T  R  A  N  S  T   R  A  C  H  E  A  L
O X Y G E N     T H E R A P Y

CLINICAL   GUIDE
FOR  THE
FASTTRACT

I N S E R T I O N   T E C H N I Q U E

 

 

Copyright 1997-2001, Transtracheal Systems, Inc.

 

CONTENTS

 

Transtracheal Oxygen Introduction

PHASE I:    Patient Orientation, Evaluation, Selection and Preparation

PHASE II:    Fast Tract™ Procedure and Stenting

PHASE III:    Initiation of TTO and the Immature Tract   

PHASE IV:    The Mature Tract

 

Transtracheal Oxygen Introduction

The Nocturnal Oxygen Therapy Trial (NOTT)1 concluded that continuous oxygen therapy delivered to ambulatory hypoxemic patients improved survival and quality of life. But the “continuous” group in that study only used oxygen for an average of about 18 hours per day, and most clinicians recognize that few patients wear nasal prongs continuously. Nasal prongs are often removed because of discomfort, restricted mobility or cosmetic concerns. Prongs are also unstable and are frequently dislodged when the patient sleeps. Pulmonologists and otolaryngologists may be most familiar with the myriad complications and discomforts associated with the use of nasal prongs.

Patients most commonly seek transtracheal oxygen (TTO) as an alternative to nasal prongs because of discomfort and restricted mobility associated with the nasal prongs.2 Greater convenience and oxygen conservation are of intermediate importance, and appearance is least important when patients are asked to rank these issues as they enter a transtracheal program.

Transtracheal oxygen therapy offers many benefits which meet the therapeutic goals identified in the NOTT study in a cost effective way (see summary below). True 24 hour per day compliance, a more active lifestyle and conservation of oxygen resources are all feasible with this technology. The average TTO patient has a 55% reduction of oxygen flow at rest and a 30% decrease with activity.3-6 Even allowing for increased compliance from an average of 18 hours per day to 24 hours per day, transtracheal patients average about 20% less bulk oxygen consumption compared to oxygen delivery by nasal prongs. TTO can be used in tandem with oxygen conservation devices, and in that way further reduce bulk oxygen consumption. Transtracheal oxygen therapy has also been shown to increase exercise tolerance and decrease the oxygen cost of breathing.7,8

Summary: Benefits of Transtracheal Oxygen

Physiologic benefits
    · Reduced erythrocytosis
    · Reduced pulmonary vascular resistance
    · Improved cor pulmonale
    · Improved A-a DO2 while breathing room air
    · Decreased physiologic dead space
    · Reduced inspired minute ventilation
    · Reduced work of breathing
    · Improved exercise capacity
    · Improved oxygenation during sleep

Improved mobility
    · Greater exercise tolerance
    · Longer lasting, lightweight portable oxygen
    sources
    · Reduced dyspnea

True 24 hour per day compliance
    · Greater comfort
    · Elimination of nasal cannula complications
    · Improved self-image

Reduced hospital days and cost

Improved survival

The SCOOP transtracheal oxygen program has been developed and refined since its inception in 1985. Although safety, efficacy and a high rate of patient acceptance has been established in the literature, the technology has actually been utilized in a relatively small proportion of potential candidates with chronic hypoxemia.3,4,9 Underutilization of transtracheal oxygen therapy may be due to several factors. Two primary factors are that the pulmonary physician may lack familiarity and comfort with the initial catheter insertion procedure; and, scheduling, patient education and post procedure care may place too many demands on physician time.

To address these and other clinical issues, an alternative method for placing the SCOOP oxygen catheter has been developed. The Fast TractTM procedure, performed by a qualified surgeon to gain airway access to the trachea, allows for earlier initiation of transtracheal oxygen delivery, facilitates rapid tract maturation and reduces the incidence of problems related to mucus balls, lost tracts, chondritis and keloids.9 It can be seen as a first line procedure for patients as well as a revision procedure for patients with chronic tract problems following a Modified Seldinger Technique. Fast TractTM expedites the transtracheal oxygen process and in a managed care environment, allows the surgeon or pulmonologist to return the patient to the primary physician with a relatively trouble free tract in a reduced period of time. The potential benefits of faster tract maturation with fewer complications include a broader physician referral base and broader patient acceptance.

The following summarizes the SCOOP program of care utilizing the Fast TractTM procedure. The program consists of four clinically defined phases which integrate transtracheal catheters and supplies specifically designed for the program with the patient’s existing oxygen equipment.

Four Clinically Defined Phases

Phase I        Orientation, Evaluation, Selection and Preparation

Phase II    Fast TractTM Procedure and Stenting

Phase III    Transtracheal Oxygen Therapy - Initiation of TTO and Immature Tract

Phase IV    Transtracheal Oxygen Therapy - Mature Tract

The SCOOP system is designed to meet the physiologic and biomechanical needs of long-term transtracheal oxygen therapy. The system maximizes safety and efficacy while remaining compatible with existing oxygen equipment. The catheters and hoses permit flow rates up to 6 L/min. at less than 2 p.s.i. back pressure and may be used with standard 2 p.s.i. pop-off humidifiers, fixed orifice flow meters and concentrators. Patients with flow rates greater than 6 L/min. may require a humidifier with a 6 p.s.i. pop-off.

Concerns about the potential for excessive oxygen delivery with retained CO2 have not been realized, and high flow rates may actually facilitate the wash out of CO2. Preliminary investigations to explore high transtracheal flow rates as a means to augment ventilation have shown promising results.6

The SCOOP catheters are made of high tech biopolymers which resist kinking and crushing. The internal tubing is radiopaque and is available for adults in 9 cm, 11 cm, and 13 cm internal lengths. The thermoplastic tubing rapidly takes a set at body temperature and allows the catheter to conform to individual patient anatomy.

The catheter rests gently against the posterior membranous tracheal wall and is insensible with normal respiratory movements. The overall flexibility of the catheter is carefully controlled to balance stability (stiffness) with comfort (flexibility). The catheter tip is beveled and molded to facilitate easy insertion and is oriented to direct gas away from the tracheal mucosa. The SCOOP catheter has one distal port and is used by all patients in Phase III when the catheter is cleaned in place. The SCOOP catheter is also used in Phase IV when the tract is fully matured and daily removal of the catheter for cleaning is feasible.

The external tubing extension removes the connectors away from the flange at the collar line for improved comfort and ease of manipulation. The flange and external tubing are made of clear plastic to minimize visibility. The flange is small and, when used with a properly fitted SCOOP bead chain necklace, allows air to get to the skin around the tract opening and avoids maceration by secretions. When the flange is upright and readable, the internal portion of the catheter is oriented for comfort and efficiency. The standard luer taper connector fits most unit dose saline vials, Blairex saline canisters, standard luer taper syringes, and the SCOOP oxygen hose.

SCOOP cleaning rods are made for both cleaning in place and removal for cleaning. The tip of the rod is atraumatic, and the length extends slightly past the tip of the catheter. The same cleaning rod fits the 9 cm, 11 cm, and 13 cm catheters as the overall length of the catheters remains a constant 20 cm.

The SCOOP oxygen hose is available in nine size combinations to fit various patient sizes and upper body to lower body proportions. These hoses are made of clear plastic to minimize visibility. The supple small caliber upper body tubing is worn beneath the clothing. The larger caliber kink and crush resistant lower body segment connects to the upper body segment at a security clip which attaches to the top of the lower body clothing on the right side.

Security, reliability and comfort have been considered along every segment of the system from the tip of the catheter to the oxygen source. The procedures and protocols which make best use of the SCOOP system are the subject of this guide.


References

1.    Nocturnal Oxygen Therapy Trial Group. Continuous or nocturnal oxygen therapy in hypoxemic chronic obstructive lung disease: a clinical trial. Ann Intern Med 1980; 93:391-8.

2.    Spofford BT, Christopher KL, Petty TL, et al. Why do patients want transtracheal oxygen? (abstract) AM Rev Resp Dis 1988; 137:A445.

3.    Christopher KL, Spofford BT, Petrun MD, et al. A program for transtracheal oxygen delivery: assessment of safety and efficacy. Ann Intern Med 1987; 107: 802-8.

4.    Christopher KL, Spofford BT, Brannin PT, Petty TL. Transtracheal oxygen for refractory hypoxemia. JAMA 1986; 256:494-7.

5.    Spofford BT, Christopher KL, Goodman JR, et al. Nationwide experience with the SCOOP transtracheal oxygen program. Presented at the International Conference on Pulmonary Rehabilitation and Home Mechanical Ventilation, Denver: 4 March 1988.

6.    Christopher KL, Murry I, Simpson R, et al. Transtracheal augmentation of ventilation. (abstract) Chest 1989; 96:174S.

7.    Benditt J, Pollock M, Roa J, Celli B. Transtracheal delivery of gas decreases the oxygen cost of breathing. Am Rev Resp Dis 1993; 147:1207-1210.

8.    Wesmiller SW, Hoffman LA, Sciurba FC, Ferson PF, Johnson JT, Dauber JH. Exercise tolerance during nasal cannula and transtracheal oxygen delivery. Am Rev Resp Dis 1990; 141:789-791.

9.    Lipkin A, Christopher KL, Yaeger E, Diehl S, Jorgenson S. Otolaryngologist role in transtracheal oxygen therapy. Otol. Head and Neck Surgery 1996; 115:447-53.

 

PHASE I:
Patient Orientation, Evaluation, Selection and Preparation

Phase I Goals

    · Inform the patient
    · Identify contraindications and precautions
    · Select the right patient
        -identify good starting candidates (>10%)
        -observe precautions with majority (80%)
        -exclude poor candidates (<10%)
    · Stabilize the patient before the procedure

General Indications

General indications for transtracheal oxygen therapy are the same as for oxygen delivered by nasal prongs. Continuous oxygen is indicated for patients with chronic hypoxemia which persists in spite of optimal medical therapy. Arterial blood gases obtained on room air should show a PaO2< 55 mm Hg. Transtracheal oxygen is also indicated for patients with a PaO2 of 56-59 mm Hg if they also have: 1) dependent edema caused by congestive heart failure, 2) “P” pulmonale on EKG (P wave greater than 3mm in standard leads II, III, or AVF), or 3) erythrocythemia with a hematocrit > 55%. Room air oximetry may also be used to document the need for oxygen if the SaO2 < 85% or if 1, 2 or 3 is present with an SaO2 of 86-89%.

General Indications
Long-Term Oxygen Therapy

    · PaO2< 55 mm Hg
    · PaO2= 56-59 mm Hg with
        -dependent edema
        -p wave > 3mm in II, III or AVF
        -hematocrit > 55%
    · SaO2< 85 mm Hg
    · SaO2= 86-89 mm Hg with
        -dependent edema
        -p wave > 3mm in II, III or AVF
        -hematocrit > 55

Specific Indications

Specific indications for transtracheal oxygen therapy include: 1) a need for improved mobility, 2) noncompliance related to nasal prongs, 3) complications of nasal prongs, 4) cor pulmonale or erythrocythemia on nasal oxygen, 5) refractory hypoxemia, 6) nocturnal desaturation corrected by TTO, and 7) patient preference. Mobility may be improved by the extension of portable oxygen sources and better exercise tolerance. Complications of nasal prongs are common and include ear sores, serous otitis media, nasal sores, nasal crusting, nose bleeds, diminished sense of smell and taste, tear duct blockage, chronic dry sore throats, hoarseness, and burns caused by ignition of the nasal prongs. Cor pulmonale or erythrocythemia with an adequate PaO2 suggest noncompliance with nasal prongs.

Specific Indications
Transtracheal Oxygen Therapy

    · Need for improved mobility
    · Noncompliance related to nasal prongs
    · Complications of nasal prongs
    · Cor pulmonale or erythrocythemia on nasal oxygen
    · Refractory hypoxemia
    · Nocturnal desaturation corrected by TTO
    · Patient preference

Contraindications

Contraindications include mental or physical incompetence which would interfere with use of a transtracheal catheter. Transtracheal oxygen should not be used in patients with a severe anxiety neurosis. Transtracheal oxygen at typical flow rates < 2L/min. is usually insensible, and severely anxious patients often worry that they are not getting their oxygen. Moreover, these anxious patients may also perceive transtracheal oxygen as more complex and intimidating. Because of the risk of pneumothorax, the procedure should not be performed if a pre-procedure chest x-ray shows pleura herniated over the proposed procedure site. Transtracheal oxygen also should not be used if subglottic stenosis, bilateral vocal cord paralysis or any other cause of a significant upper airway obstruction is present. The transtracheal catheter and possible formation of mucus balls could seriously aggravate the upper airway obstruction.

Absolute Contraindications
Transtracheal Oxygen Therapy

    · Severe anxiety neurosis
    · Poor compliance with medical therapy
    · Mental or physical incompetence
    · Upper airway obstruction
    · Pleura herniated over puncture site

Orientation

Patients are fully informed about the potential benefits and risks of transtracheal oxygen therapy before making a commitment to proceed with the procedure. An ideal orientation includes viewing the orientation segment in the SCOOP Oxygen Program for Patients training video, a question and answer session with a knowledgeable health care professional and an opportunity to talk or meet with a transtracheal patient. Interested patients should then receive a SCOOP Patient Workbook and Guide and have a basis to identify precautions and possible contraindications.


Evaluation

All patients have a targeted history, physical examination, and basic laboratory evaluations. Selected patients may require additional tests. The SCOOP Patient Chart is an especially useful record keeping tool which prompts the clinician to seek specific information relevant to the success of the transtracheal program. For example, the history would normally inquire about bed clothing. This is important information because catheter security routines require that the upper segment of the hose remain under upper body clothing and that the security clip be attached to the lower body clothing (or a belt) at all times.

The physical exam should also include careful examination of the nose including nostrils, septum and mucosa. The ears are examined for helical chondritis or irritation and other problems such as serous otitis media. Observations in the neck should include length, thickness, deviation of the trachea, position of the larynx and position of anterior neck veins. The neck anatomy is inspected and palpated with the Fast TractTM procedure in mind.

TTO Candidate Evaluation

    · Arterial blood gases (room air)
    · Arterial blood gases (on nasal oxygen)
    · Hematocrit
    · Spirometry (pre and post bronchodilator)
    · Chest x-ray (PA and lateral) with properly fitted bead chain
    necklace

Basic laboratory data is gathered on all individuals. Arterial blood gases on room air and on nasal prongs are obtained to document the need for oxygen therapy, to identify any risk factors for transtracheal oxygen therapy and to give the patient an estimate of reduced oxygen flow on transtracheal oxygen. For example, a patient with an inadequate PaO2 of 47 mm Hg on 2 L/min. by nasal prongs may be disappointed to only go down to 1.5 L/min. on SCOOP even through the PaO2 goes up to 65 mm Hg. The hematocrit is an easy test which reflects on the overall adequacy of oxygen therapy. A shift on transtracheal oxygen from a high normal hematocrit to a mid or low normal hematocrit is common and suggests better 24 hour per day oxygenation. Spirometry (both pre and post bronchodilator) is used to estimate the risk for bronchospasm during the Fast TractTM procedure and to assess ventilatory reserve. Posteroanterior and lateral chest x-rays with properly fitted bead chain necklace are helpful in excluding rare individuals with pleura over the anterior neck and identifying unusual variants of anatomy before the transtracheal procedure.

Surgical Preoperative Evaluation

    · EKG
    · CBC
    · SMA 22
    · UA
    · PT

Certain tests are routine screens as a preoperative evaluation. Though exact studies may vary according to the surgeon and institution, an example of preoperative studies are noted above.

Additional laboratory data may be helpful in individual cases. Special tests may include exercise oximetry, a 100% FiO2 study, lung volumes, diffusion capacity, or an electrocardiogram. The 100% FiO2 study warrants special discussion. Although SCOOP transtracheal oxygen is efficacious in many patients with refractory hypoxemia, it cannot be expected to oxygenate all patients. Two patients with refractory hypoxemia and inadequate oxygenation on maximal nasal prong therapy may have PaO2 results of 50 mm Hg and 150 mm Hg with an FiO2 of 100%. Only the second patient is a good candidate for SCOOP.

Additional Laboratory Data

    · Exercise oximetry
    · 100% FiO2 study (refractory hypoxemia)
    · Lung volumes and diffusion capacity

 

MOC Score
Risk Assessment

                                                              0                        1                        2
    · Mechanical reserve (FEV1)         M0:>1.0          M1:.50-.99          M2:<.50
    · Oxygenation (PaO2 on O2)         O0:>55             O1:50-55           O2:<50
    · CO2 (PaCO2 on O2)                  C0:<40             C1:41-50           C2:>50

After completing these evaluations, MOC (Mechanical reserve, Oxygenation, CO2 retention) and SAL (Score for Activity Level) scores are determined. These are easily determined from the history, spirometry and blood gas results (on oxygen). The MOC score is useful for identifying especially fragile patients who must be observed more closely during the procedure, the night after the procedure and during Phase III. The SAL score is useful in identifying more active patients who are the best starting candidates. The SAL is a simple score which also permits charting of changes in activity level related to changes in treatment.

Score for Activity Level (SAL)
Risk Assessment

    1 = Bedridden
    2 = Housebound except for doctor visits; out of bed < 12 hours/day
    3 = Housebound except for doctor visits; out of bed > 12 hours/day
    4 = Leaves home for shopping and other needs of daily living
    5 = Routinely leaves home for socializing, recreation or work

Selection

The physician now has the information needed to complete the pre-procedure review. It requires that the physician review the findings of the evaluations and consider indications, contraindications and precautions. Candidacy and special considerations are discussed with the patient, and informed consent is obtained. Thereafter, the patient is medically and psychologically prepared for the procedure.

The Fast TractTM procedure and program should be undertaken by a team in a graduated fashion starting with easier patients and progressing to more difficult patients after experience has been gained. The transtracheal team includes the surgeon, pulmonologist, referring physician, respiratory therapist or nurse, patient, significant other, and home care provider. The first ten procedures should be performed on patients who fit the criteria listed below. An active individual who is early in the natural history of lung disease will be around for a long time to help counsel subsequent patients. The first six months should be considered a learning period. During this start-up phase, the team should expect to see a slightly higher morbidity rate. With experience, transtracheal oxygen therapy will become progressively more routine and morbidity will steadily decline.

Transtracheal Team

    · Surgeon
    · Pulmonologist
    · Respiratory Therapist or Nurse
    · Patient and Significant Other
    · Home Care Provider

Initial Patient Selection
First 10 Patients

    · Not refractory (no individual MOC = 2)
    · Active (SAL = 4 or 5)
    · Lives nearby and has reliable transportation
    · Slim or medium neck
    · No severe disabling anxiety
    · Motivated and cooperative

More challenging patients with obese necks, copious sputum, reactive airways, coagulation disorders, or moderate anxiety as well as patients who live more than one hour away can be considered after the team has acquired experience with the first ten relatively easier patients. The majority of patients can be successfully treated by a team with enough experience to anticipate and avoid most potential problems. When minor morbidity occurs, the team is able to recognize and intervene definitively.

Precautions

    · Poor mechanical reserve
    · Profound hypoxemia
    · Hypercarbia without acidemia
    · Obese neck or other anatomic abnormality
    · Mild to moderate anxiety neurosis
    · Bronchial hypersensitivity
    · Copious or viscous sputum
    · Serious cardiac arrhythmia
    · Bleeding disorder

The efficacy of TTO in refractory hypoxemia has unfortunately suggested to some that TTO is most appropriate for end-stage patients. Many physicians feel pressured to “do something” when patients begin a rapid preterminal phase. These patients are most challenging, and the inexperienced team will experience high morbidity and mortality. Transtracheal oxygen can become stigmatized with the image of reckless heroics. This is unfortunate because TTO is best used early in the natural history of COPD and other disorders resulting in chronic hypoxemia. Transtracheal oxygen is the first practical means of delivering true 24-hour per day ambulatory oxygen and is a superior means of preventing sequelae of hypoxemia for the typical oxygen dependent patient. The message is clear - don’t start with refractory patients!


Preparation

Patients should be under optimal medical treatment and stable at the time of the Fast TractTM procedure. In some circumstances, this may require the administration of antibiotics or steroids. In others it may call for interruption of anticoagulation therapy. No fixed interval should be set between the pre-procedure review and the procedure when patients are unstable. It may take several weeks to get an unstable patient in shape for the procedure.

Normal Sequelae
Informed Consent

    · Transient tenderness at puncture site
    · Transient increase in coughing
    · Transient changes in sputum
        -increased volume
        -blood streaking
    · Closure of tract (if catheter removed)
    · Reduced ability to phonate (temporarily)

Informed consent is obtained at the time of the pre-procedure review. Sequelae are differentiated from complications, because they are normal for most patients to experience.

Potential Complications
Informed Consent

    · Extravasted air
        -subcutaneous emphysema (1%)
        -pneumothorax (rare)
    · Infection
        -tracheal chondritis (12%)
        -cellulitis (rare)
        -abscess (rare)
    · Bleeding > 10ml (rare)
    · Acute respiratory failure (1%)
    · Keloid formation (rare)
    · Symptomatic mucus balls (15%)

Planning Ahead

A patient who is adequately prepared will arrive composed and mentally ready for SCOOP transtracheal oxygen therapy. Preparation details include measurement of the SCOOP oxygen hose, catheter size assessment, a scheduled visit with the surgeon, and arrangements for procedure supplies. Once informed consent is obtained, the SCOOP oxygen hose to be worn in conjunction with the SCOOP transtracheal catheter is customized to the patient. Have the patient stand to be measured for the SCOOP oxygen hose. A cloth measuring tape is used to measure the gentle arc from the notch of the manubrium to the right hip in inches. This is the upper length. A second measurement is taken from the hip to the tank as the patient stands next to the portable source. A short loop in the lower length is desirable to permit walking a few steps away from the portable source, but it should not be so long as to touch the floor and create a hazard for tripping. Hoses are available in 12, 15, 20 and 25 inch upper lengths and 40, 50 and 60 inch lower lengths. The H-2050 (20 inch upper length, 50 inch lower) is the most common size hose. The SCOOP Oxygen Hose is designed to be worn on the right side of the lower body clothing.

Catheter length needs to be assessed for all patients. The standard adult catheter is 11 cm long. If the patient falls out of the standard range, a 9 cm or 13 cm length might need to be considered. It is recommended to start with the 11 cm catheter, but a chest x-ray post catheter insertion will be needed to confirm proper length. The goal is to see the catheter tip 1-2 cm above the carina.

Typically, the patient is referred to the surgeon who will be performing the Fast TractTM procedure after an evaluation and work-up. The surgeon’s office will schedule the procedure and dispense all preoperative instructions to the patient regarding time and place to report for the procedure, medications to be taken and when to become NPO prior to the procedure. Patients should be instructed that they will spend the night in the hospital.

Although supplies for the stent removal/catheter placement procedure on post op day one are provided in the patient portion of the T-10 System Pack, it is important to notify the hospital’s respiratory therapy department to provide back-up for all supplies necessary for the procedure.

The SCOOP Oxygen Hose is designed to be worn on the right side of the lower body clothing.

SCOOP Oxygen Hose Fitting

 

PHASE II:
Fast Tract™ Procedure and Stenting

Phase II Goals

    · Create a quality tract
        -proper level for stability
        -not through cricothyroid membrane
        -in the midline of the trachea
    · Do not destabilize the fragile patient
        -on day of procedure
        -during day after procedure

The best time to do the procedure is early in the week. This allows the patient to be monitored in the hospital for the remainder of the day, the next morning, and then at home throughout the week. Patients should arrive in optimal medical condition and be psychologically prepared for the Fast TractTM procedure.

The patient arrives at the hospital at the time specified by the surgeon’s office, having followed the NPO guidelines established previously by the surgeon.

The following information should already be on the patient’s chart - the pulmonologist’s current history and physical, EKG, requested laboratory results, and any other pertinent data obtained from the evaluation interviews with the pulmonologist and surgeon.

The surgeon briefly reviews and evaluates the patient prior to the procedure, answering any additional questions that the patient may have. The pulmonologist is available if needed for further preoperative care. A brief interim history and physical is taken to identify any new symptoms such as increased cough, purulent sputum, or wheezing. The patient’s oxygen saturation on the nasal cannula or mask should be checked via pulse oximetry to ensure adequate oxygenation. If the patient is unstable for any reason the procedure is postponed.

Typical Preoperative Orders

    · Procedure: Tracheostomy with skin flaps - access procedure for transtracheal oxygen therapy
    · Plan on overnight admission postoperatively
    · Allergies
    · NPO guidelines:
        -8 hours for solids or non-clear liquids
        -4 hours for clear liquids
        -oral medications with sips of water up to 1 1/2 hours prior to surgery
    · Use metered dose inhalers or nebulized bronchodilator 1/2 hour prior to surgery
    · Intravenous hydrocortisone 100mg IV
    · Hold anticoagulants
    · History and physical by pulmonologist - must be on the chart
    · Have on the chart: recent CXR report, spirometry results, ABG results, EKG, CBC, SMAC, and UA
    · Oxygen via nasal cannula and or mask; titrate to keep SaO2 above 92%

If the patient is stable, an IV is started, and the previously ordered medications are administered. Patients at risk for bronchospasm are given a nebulized bronchodilator or MDI thirty minutes prior to the procedure per pulmonologist order.

In the pre-operative holding area, the anesthesiologist reviews the patient’s chart and conducts a brief interview to assess cardiopulmonary functional status and ascertain optimal condition for surgery. In particular, NPO status and history of reactions to medications and anesthesia is noted, the airway is inspected, and the (ASA) physical status is designated. If needed, sedation may be administered in prudent doses to the anxious patient at this time. Pulse oximetry monitoring is initiated.

Upon arrival at the OR suite, the surgeon fits the bead chain necklace to enable proper catheter placement. A bead chain necklace is passed around the patient’s neck. A proper fit will usually accommodate two fingers snugly between the neck and the chain, but not excessively tight with neck hyper-extension or heavy coughing. It is suggested that the chain not be cut at this time but only used for proper catheter placement marking, due to possible mild neck swelling with the procedure. The chain will be checked again for proper fit prior to stent removal/catheter placement. This may be done by the surgeon or pulmonologist or under the direct supervision of the physician, a respiratory therapist or nurse. The patient is seated in a high Fowlers position in the bed with the head square on the shoulders. This position should help avoid rotational distortion of the neck anatomy. Attention is focused on the anterior neck. The head of the bed should be angled up 80o and the patient is instructed to slightly extend the neck. The ideal neck position is the same as when the patient is looking into a mirror at his or her own neck.

The nasal prongs are positioned to arrive from behind. This leaves the anterior neck unobstructed. Patients who are wearing masks should have the device inverted and taped to the forehead.

The notch of the thyroid cartilage is marked using a surgical marking pen with a “V

The cricothyroid membrane is marked with a horizontal “      
The notch of the manubrium is marked with a gentle “U

The most recent PA and lateral chest x-rays are reviewed prior to marking the procedure site. With the neck sightly elevated and square on the shoulders, the superficial anatomy of the anterior neck is palpated. Special attention is paid to anterior neck veins and position of the trachea. The notch of the thyroid cartilage is marked using a surgical marking pen with a “V”, the cricothyroid membrane is marked with a horizontal “     “, and the notch of the manubrium is marked with a gentle “U”. The cervical trachea rests between the “     “ and the “U” and creates a vertical axis. With the fitted bead chain necklace in place, the crossing point may be marked using the surgical pen with two dashes laterally over the sternocleidomastoid muscles. In about 85% of patients, the necklace will cross at the first or second interspace. In about 10%, it will cross lower; and in 5%, it will cross the cricothyroid membrane. In the latter case, the chain is loosened to permit it to dip to the first tracheal interspace. The necklace is removed and saved for use the following day when transtracheal oxygen is initiated.

A tract should not be created through the cricothyroid membrane because it predictably results in hoarseness. This appears to be related to the presence of the cricovocal ligament passing from the cricoid up to the vocal cords. More importantly, experience with the procedure has demonstrated that tracts through the cricothyroid membrane often become indurated and tender. Keloids may form and make catheter insertion difficult. Many tracts created at this level subsequently require revision.

The patient is positioned supine on the operating table with the neck gently extended and a roll is placed under the shoulders. The head of the bed may be elevated slightly for patient comfort. Monitors are applied: BP cuff, EKG, and pulse oximeter. The degree of sedation to be provided will depend on the previous clinical assessment. Small doses of midazolam (0.5-1.5 mg) and fentanyl (25-75 micrograms) will be tolerated by nearly all patients and will not only provide relaxation, but the fentanyl will also depress the cough reflex. In addition, many patients will be able to tolerate amnestic, if not induction doses of propofol (30-70 mg) or methohexital (20-60 mg) just prior to injection of local anesthesia by the surgeon. Nasal O2 is provided throughout. Although it is rarely necessary, a patient may be converted to general anesthesia on an emergency basis.


figure 1

The area between the cricoid and sternal notch is infiltrated with lidocaine 1% with epinephrine 1:100,000. The neck is prepped and draped. Using cutting cautery, a vertical incision of approximately 1.5 to 2 cm is centered on the site selected by the surgeon (Reference Figure 1). Flaps of full-thickness skin are elevated laterally 2 cm in each direction. The cutting cautery is then used to perform a cervical lipectomy, removing all the fat down to the level of the strap muscles (Reference Figure 2). The strap muscles are separated at the midline, exposing the anterior wall of the trachea (Reference Figure 3). Occasionally, division of the thyroid isthmus is necessary.


figure 2

figure 3

The previously elevated skin flaps are then used to fashion an epithelialized tract down to the anterior wall of the trachea. This is performed by suturing the flaps to the undersides of the previously exposed sternothyroid muscles with a running suture of 3-0 vicryl or similar absorbable material (Reference Figure 4). It may be reinforced with additional interrupted sutures as necessary. Prior to entering the trachea, the entire surgical field is inspected and complete hemostasis is obtained. Additional local anesthetic (lidocaine 1% without epinephrine) is injected into the tracheal wall and lumen, particularly at the point of entry into the trachea. This will help prevent movement and coughing when the trachea is entered. Since oxygen in high concentration is flowing into the trachea, the electro cautery cutting blade should never be used to enter the trachea.


figure 4

The trachea is then entered with a small horizontal incision in the interspace between two upper tracheal rings previously marked by the necklace (Reference Figure 5).


figure 5

The blunt end of the punch is passed through the incision, the punch is engaged (Reference Figure 6), and a small window of cartilage is resected (Reference Figure 7). In cases with scarred or calcified tracheal cartilage, or with revision on tracts that had been created with previous techniques, a Boston Medical Products fenestrator or scalpel can be utilized. With a circular motion, gentle pressure is placed on the fenestrator, creating an opening in the trachea. Suction is applied to the end of the fenestrator, capturing the resected cartilage.


figure 6

figure 7

Using the available stylet, the stent is inserted into the tracheal window (Reference Figure 8). A trach dressing is placed over the procedure site, and ties or straps are then used to secure the stent in proper position. A trach collar is applied to the stent to provide humidity for the patient’s comfort. Oxygen is supplied by nasal prongs and/or mask to achieve an oxygen saturation of > 90% via pulse oximetry.


figure 8

Post-Op Stenting Routine

The patient is transported to the Recovery Room at the conclusion of the surgery for monitoring for 1/2 - 3/4 hour. While in the Recovery Room, the patient should have a posteroanterior and lateral chest x-ray. This should document the absence of extravated air (subcutaneous emphysema, pneumomediastinum and pneumothorax) and confirm the intratracheal location of the radiopaque stent. The relationship of the tip of the stent to the carina is noted. If the tip is closer than 1 cm to the carina, a shorter catheter should be obtained before transtracheal oxygen is started the next day. The sedative and anesthetic agents utilized during the procedure are short-acting, and at judicious doses, the sedative and cardiopulmonary effects are largely dissipated within one hour, even in elderly or debilitated patients. Once stabilized the patient is moved to the floor where he or she will stay until the next morning when transtracheal oxygen is initiated.

Once in the Recovery Room, the patient is often evaluated by the pulmonologist. The head of the bed should be elevated to 45o. Vital signs and pulse oximetry are continuously monitored to keep O2 saturations at the appropriate level. Bronchodilator medications are used as needed per physician’s order, and the stent may be suctioned with an 8 French suction catheter, if needed for secretion clearance.

Post-operative drugs are dispensed per pulmonologist. IV fluids are maintained along with the appropriate antibiotics, cough suppressant and analgesics. Topical lidocaine (without epinephrine) may be instilled into the stent to further reduce coughing. Pre-op medications may be restarted. Anticoagulants such as aspirin, Heparin and Coumadin are held for one day and restarted again on post-op day one.

Typical Post-Operative Orders

    · Status post-tracheostomy with skin flaps - access procedure for transtracheal oxygen therapy
    · Admit to Recovery Room with transfer orders to the floor
    · Allergies
    · Consult pulmonologist
    · Vital signs; q 1 hour times 4, then q 4 hours
    · Elevate head of bed 45 degrees
    · Out of bed with assistance only
    · Diet: start with liquids, advance to soft regular diet as tolerated
    · IV fluids @ 100 cc/hr. Cap IV when taking PO liquids
    · Oxycodone 1 or 2 PO q 4 hours prn pain OR Demerol mg IM q 3 hours prn pain
    · Hydroxyzine hydrochloride mg IM q 3 hours prn nausea
    · Cephalexin 250 mg PO qid
    · Guaifenesin LA 2 tabs PO bid
    · Benzonatate 2 tabs tid prn cough
    · Steroids
    · Restart anticoagulants on post-op day one
    · Resume other pre-op medications
    · Orders for respiratory therapy
    · Oxygen: Trach mist with nasal cannula and/or mask to keep titrated to O2 saturation > %
    · Suction stent prn with an 8 French suction catheter
    · Lidocaine 1% liquid (not viscous) - instill 1 cc in stent q 3 hours prn cough
    · Medications via nebulizer
    · Arrange through the Respiratory Therapy Department to have the following supplies ready for the stent removal/catheter placement procedure on post-op day one: SCOOP 11 cm transtracheal catheter with cleaning rod, SCOOP oxygen hose, bead chain necklace, bead chain wire cutters, wire guide, 1% Lidocaine, luer taper syringe with needle, water soluble lubricant, cotton tipped applicators, 3% hydrogen peroxide, 4x4 gauze, Opsite or Tegaderm, Blairex saline or unit dose vials, facial tissue, oximeter, protective glasses, examination gloves, nasal cannula, bubble humidifier, O2 adapter, and SCOOP Oxygen Program for Patients training video.
    · Remind family or significant other to bring patient’s portable oxygen system (cylinder or liquid completely full) for AM discharge
    · Discharge is planned for the following day after the stent is removed and the SCOOP catheter is inserted

Extensive experience with TTO suggests that a prophylactic antibiotic (effective against staphylococcus) is beneficial for seven days following the procedure. The existing body of literature about antibiotic prophylaxis does not address the special considerations of cartilage. Failure to administer antibiotics for these longer periods may result in tracheal chondritis two or three weeks later.

As the tracheal anesthesia wears off, most patients develop some degree of cough. The severity of the cough is assessed after the procedure and a cough suppression plan is designed. Patients with a low FEV1 or interstitial lung disease are at higher risk to cough. Brisk coughing is rare when patients are allowed to accommodate the foreign body before the SCOOP catheter is inserted. Patients should be instructed to control any urge to cough, because it may result in respiratory fatigue or subcutaneous emphysema. Benzonatate, 2 tablets 3 times a day and PRN, are dispensed as needed. Additionally one to two cc of 1% liquid lidocaine (without epinephrine) can be instilled into the stent every 3 hours as needed for cough which may help augment the oral cough suppressant. In some cases it may be necessary to instill the topical lidocaine more often, or use a stronger percentage (i.e. 2%).

Once stabilized, the patient is discharged from the Recovery Room and transferred to the floor. The patient may be out of bed with assistance only and diet may be advanced from liquids to soft regular diet as tolerated. Oxygen saturations and respiratory status are monitored, and suctioning as needed is done via the stent with an 8 French suction catheter to facilitate secretion clearance. The site around the stent is kept as clean and dry as possible using a cotton tipped applicator and 3% hydrogen peroxide, and a standard trach dressing.

Discharge is planned for the following day after the stent is removed, and the SCOOP catheter is inserted. Families should be reminded to bring the patient’s full portable oxygen system for discharge the next day.

Transtracheal Systems, Inc. provides the Fast TractTM System Pack (Surgical Kit with 9 cm or 11 cm catheter [catalog number T-10SP-9 or T-10SP-11] to facilitate the procedure, the overnight stay and the stent-to-SCOOP change over). A sterile 4.8 mm Fast TractTM Tracheal Punch, a sterile 4.6 OD wire reinforced silicone Fast TractTM Stent and a Dale Tracheostomy Tube Holder are furnished for the procedure. Three 8 French suction catheter kits are provided, and the sterile wire guide, two bead chain necklaces and a wire suture scissors are for use at the stent-to-SCOOP change-over. In addition, the System Pack also provides one SCOOP catheter single pack (9 or 11 cm), one SCOOP 2-pack (9 or 11 cm), one hose (H-2050), one cleaning kit (CK-6), a patient workbook and one SCOOP Oxygen Program for Patients training video (V-3).

 

PHASE III:
Initiation of TTO and the Immature Tract

Phase III Goals

    · Initiation of TTO
        -customize cleaning protocol
        -avoid/treat mucus balls - cephalad catheters
        -avoid lost tracts
        -treat tract problems
        -encourage the patient

Phase III normally begins the morning after the Fast TractTM procedure. The Fast TractTM procedure facilitates early initiation of transtracheal oxygen therapy, before a fully mature tract has occurred. This is due to the structure and integrity of the tract that has been created by the surgeon. Phase III for the Fast TractTM procedure usually lasts 10-14 days. This time period varies slightly according to the maturity of the tract.

The stent is exchanged for a functioning SCOOP catheter on post-op day one. Transtracheal oxygen flow rates are titrated at rest and with exercise, and an arterial blood gas or SaO2 is obtained at rest per physician order. The patient and the significant other are instructed about cleaning in place and observed through a cleaning cycle to confirm proper technique. Security routines to assist in avoiding lost tracts are reviewed with the patient prior to discharge.

The remainder of Phase III is spent assessing tract maturity, fine tuning patient cleaning protocols and avoiding and treating mucus balls and tract problems. Support and encouragement for the patient during this phase while the patient is adjusting to SCOOP oxygen therapy is equally important.

Prior to the post-op day one visit by the pulmonologist or otolaryngologist, back-up supplies for the initiation of SCOOP TTO should be available from the Respiratory Therapy Department. Remember that the catheters, hose, cleaning kit and a patient training video are provided in the patient section of the Fast TractTM System Pack. These supplies should follow the patient from the operating room to the floor.

Supplies Required for Stent-to-SCOOP Change-Over

SCOOP catheter                      3% hydrogen peroxide                       protective glasses

cleaning rod                            Opsite, Tape or Tegaderm                  examination gloves

sized SCOOP oxygen hose             Blairex saline or unit dose vials            nasal prongs

bead chain necklace                          water soluble lubricant                        O2 adapter

wire suture scissors                    cotton tipped applicators                   bubble humidifier

wire guide                                               4x4 gauze                                   facial tissues

1% lidocaine                               luer taper syringe with needle                  patient chart

oximeter                                      SCOOP Patient Training video (V-3)

It is recommended to start with an 11 cm SCOOP catheter. Follow up with a chest x-ray to confirm and evaluate placement. Ideally, the catheter should be located 1-2 cm above the carina. Catheters are also available in 9, and 13 cm lengths.

The patient is positioned in the semi-Fowlers position with nasal prongs arranged to arrive from behind. The physician, respiratory therapist, or nurse puts on protective glasses and gloves, and the aerosol set-up is discontinued. The SCOOP catheter package is opened, and a small amount of water-soluble lubricant is placed on the catheter tip. The bead chain necklace is assessed for initial proper fit. Make sure that two fingers can gently rest between the neck and the chain. The chain is then cut to the appropriate length, and the previously-measured necklace is passed through the eyelets of the flange. Suction the stent with an 8 French suction catheter, per hospital policy. Draw up 2 cc’s of 1% plain lidocaine into the luer taper syringe and remove the needle from the syringe.

Hand the patient a facial tissue and warn of an incipient cough, bad taste and globus sensation which will be caused by the injection of the local anesthetic. Remind the patient not to eat or drink anything for one hour following the lidocaine injection.

Quickly inject the lidocaine into the stent. If the patient does not cough, ask the patient to cough in order to better distribute the lidocaine throughout the tracheal lumen. Wait about one minute. Clean around the stent with cotton tipped applicators and 3% hydrogen peroxide, and remove the trach ties from both sides of the stent.

Insert the flexible end of the wire guide to the black reference mark at 11 cm and withdraw the stent over the wire guide. Have an assistant or the patient hold the wire guide with the black reference mark at the level of the skin. Lubricate the SCOOP catheter and pass it, with the pre-threaded necklace, over the wire guide twirling it 360o into the tract. When the flange comes to rest against the skin, the wire guide is removed and the necklace clasp connected. Make certain that the SCOOP logo on the flange is upright and readable. Place a 4x4 gauze pad under the flange prior to taping. A 2-inch piece of clear plastic tape (Opsite or Tegaderm) is placed on both sides of the flange over the bead chain necklace (immediately to the left and right) to help avoid inadvertent dislodging of the catheter. This is usually only necessary during Phase III.

To ensure that the catheter is correctly seated, you may visualize the catheter with a penlight to confirm catheter placement in the trachea. Using a syringe filled with saline and the needle removed, connect the luer taper syringe to the catheter and withdraw the plunger. If air flow backs freely, the catheter should be in correct position. A CXR can be done if positive confirmation is desired.

Take the previously-selected SCOOP oxygen hose and attach the security clip to the top of the lower body clothing at the right hip. Pass the supple hose segment under the upper body clothing and connect to the catheter via the luer taper connector.

A pulse oximeter is placed on the patient’s finger, and the SCOOP oxygen hose is connected to the oxygen source. Initially, the flow rate is turned down to half the nasal prong flow rate. The nasal prongs are removed and the patient is titrated on transtracheal oxygen to an oxygen saturation > 90% (usually 91-92%). Adequate oxygenation and ventilation may be confirmed with an arterial blood gas, per physician order.

Using the patient’s portable oxygen source and an oximeter, ambulate the patient to determine the necessary activity flow rate. All TTO patients should have 3 flow rates documented: a resting TTO flow rate, an activity TTO flow rate and a nasal prong flow rate.

Have the patient (and if possible, the patient’s significant other) view the Phase III “Cleaning in Place” segment of the SCOOP Patient Training video. Show the patient how to clean in place, and then observe the patient cleaning in place to ensure proper technique. Cleaning in place should be done twice daily (BID). It should be recommended that the patient clean the catheter at 8:00AM and 4:00PM so that a respiratory therapist, physician or nurse can easily be contacted should the patient have questions or problems. In addition, the patient is given the SCOOP package insert with the enclosed written “Cleaning in Place” instructions. Canisters of Blairex Broncho Saline or unit dose vials of saline may be used by the patient for internal catheter cleaning, in addition to an antibacterial soap for external catheter cleaning.

Remind the patient of possible air loss and secretions from the stoma while it is healing, and possible difficulty speaking for the first few days. Normal voice should return in time. The patient can apply gentle pressure to the SCOOP flange to make phonation easier. Reassure the patient that the stoma will close around the catheter during the healing process. The patient may also experience intermittent blood tinged sputum for a few days following the procedure.

Apply a sterile gauze dressing around the stoma and tape in place to catch any drainage that might occur. Instruct the patient to use the gauze for 2 or 3 days while the stoma is healing.

Review normal security routines with the patient to help ensure against lost tracts. A properly fitted necklace should not be modified by the patient. The supple upper segment of the SCOOP oxygen hose must be worn under upper body clothing, especially in bed. Patients who wear nightgowns should fashion a cloth belt to which the security clip can be attached under the gown.

The patient should be instructed that inadvertent dislodgment of the catheter may possibly result in lost tract. Should this occur, the patient should attempt to reinsert the catheter but for no longer than 5 minutes before calling the physician’s office or emergency room. If the patient is unsuccessful in reinserting the catheter, help should be sought immediately. The nasal cannula should be worn at the prescribed flow rate and SCOOP supplies carried to the physician’s office or emergency room. (In this manner, the physician, respiratory therapist or nurse will be better prepared for the patient’s arrival.)

It should be noted that in an attempt to reinsert the catheter or during violent coughing, a “cephalad catheter” may ensue. When this occurs, the catheter passes upward through the vocal cords rather than its normal intratracheal position. The patient will experience severe coughing and discomfort and will have difficulty with phonation. If this is the case, the patient should be instructed to gently, but quickly, remove the catheter and try inserting again paying special attention to direct the catheter straight back, so that it will follow the natural curve of the posterior tracheal wall. If the patient has any questions regarding proper catheter position, he or she should call the physician’s office for further instructions. If necessary, a chest x-ray can be ordered.

Before discharging your patient, make a follow-up appointment within 3 to 5 days for a first catheter stripping and evaluation. Review the Patient Workbook and Guide and the Ten SCOOP Rules with the patient. Make sure the patient has all the necessary prescriptions, appropriate antibiotics, cough suppressant, mucoevacuent and analgesics for discharge.

Notify the patient’s homecare company of any liter flow changes and provide a prescription for appropriate catheter and hose replacement every 90 days.


Mucus Balls

Review the signs and symptoms of a mucus ball with the patient, including increasing or severe cough, severe or worsening dyspnea and increased wheezing. If any of these symptoms occur, the patient should be seen for a catheter stripping.

Mucus Ball Clinical Presentations

    · Cough, increasing or severe
    · Dyspnea, increasing or severe
    · Wheezing, increasing or severe

A mucus ball is an accumulation of inspissated mucus which adheres to the anterior and lateral surface of the catheter, just above the tip. Symptomatic mucus balls occur in 10-20% of patients in Phase III when the catheter is cleaned in place. They generally disappear in Phase IV when daily removal strips the mucus off the catheter, allowing it to be expectorated. In many patients, the trachea adapts, and mucus balls spontaneously diminish in frequency during Phase III. Although mucus balls can cause a tickle cough, dyspnea or wheezing, they rarely result in airway obstruction. The pathogenesis of their formation is related to the volume of dry gas introduced into the lower airway and baseline secretions. Patients with low FEV1 and weak cough are less able to generate the glottic blast to dislodge mucus balls and are at relatively greater risk. Ineffective cleaning, inadequate humidification, failure to periodically strip the catheter during Phase III and insufficient systemic hydration are iatrogenic factors which predispose a patient to mucus ball formation. The transtracheal team should maintain a high index of suspicion during the first week of Phase III, and mucus balls, which form in spite of adequate cleaning and humidification, should be immediately recognized and treated.

Initial Risk Assessment for Mucus Balls in Phase III

    · Low Risk
        < 1 L/min. at rest
        and no baseline mucus problem
        and no individual MOC = 2
    · Moderate Risk
        1-4 L/min. at rest
        or some baseline mucus problem
        and no individual MOC = 2
    · High Risk
        5-8 L/min. at rest
        or cystic fibrosis or bronchiectasis
        or any individual MOC = 2

The risk of forming mucus balls must be assessed when the patient returns for the first follow-up visit to the physician. This is usually scheduled during the week immediately following the procedure. The risk of mucus ball formation may be greater in the immediate post-op period due to the higher volume of room air introduced through the stoma as the tract matures.

If there is a small to moderate amount of mucus on the tip of the catheter following a catheter stripping, the cleaning schedule is increased to 3 times a day (TID), and the patient returns in 4-7 days for a catheter stripping and/or Phase IV evaluation. Review the cleaning procedure and ensure that the patient has proper humidification on the stationary oxygen system. If the patient’s flow rate is greater than 1 L/min., a high-quality 2 psi pop-off humidifier for stationary oxygen source is recommended. The patient requiring flows greater than 6 L/min. might benefit from a bubble humidifier with a 6 psi pop-off (Salter Labs Model #7600). Patients requiring higher flows or more humidity may require a servo controlled heated humidifier (Marquest or Fisher Paykel). These humidifiers can be obtained from the homecare provider.

If the patient coughs out a mucus ball after catheter stripping, increase cleaning in place to 4 times a day (QID) and start a mucoevacuent, such as Humibid L.A. (Guaifenesin) 1200 mg BID. Review cleaning and humidification with the patient and have him/her return in 3-5 days for another catheter stripping and evaluation.

Phase III Cleaning Protocols

Cleaning in Place                          Catheter Stripping
        BID                                       1 x per week
        TID                                        4-7 days
        QID                                       3-5 days

The initial cleaning and stripping protocol permits escalation or de-escalation based on actual clinical evaluation. The adequacy of cleaning should be assessed during each Phase III visit. Mucus balls can be treated in all patients, but a few with poor cough, copious secretions and high flow rates may need intense supervision which may include QID cleaning in place, use of a servo-heated humidifier and twice weekly catheter stripping throughout Phase III. The transtracheal team must master the art of preventing, recognizing and treating mucus balls.

Phase III Follow-Up Visits

    About 10 minutes
        1. Check necklace fitting
        2. Check appearance and maturity of tract
        3. Strip catheter over wire guide
        4. Check oxygen saturation by oximetry

Subsequent scheduled and unscheduled visits during Phase III should always include a check of the bead chain necklace fitting, appearance and maturity of the tract, catheter stripping and oximetry. These can often be accomplished in about 10 minutes. The frequency of monitoring should remain flexible and be adjusted according to actual clinical evaluation. The following table summarizes the steps involved in stripping the SCOOP catheter.

Catheter Stripping Protocol - III

    1. Patient uses nasal prongs during stripping
    2. Clean crusts from tract opening
    3. Instill 2 cc of 1% plain lidocaine into catheter
    4. Insert wire guide to 11 cm mark
    5. Remove soiled catheter
    6. Assistant or patient holds wire at black reference mark
    7. Wash catheter and apply water soluble jelly
    8. Reinsert SCOOP catheter and connect necklace
    9. Place 2 inch piece of Opsite, Tegaderm or tape over the
    bead chain necklace on each side of the flange
    10. Reconnect catheter and remove nasal prongs
    11. Check oxygen saturation by oximetry

Catheter Dislodgment

Dislodgment of the catheter during Phase III rarely results in closure of the tract, but lost tracts are a problem that require immediate attention. The physician should have a sterile catheter and wire guide available for possible emergent use. In the event of dislodgment, the patient must be seen immediately, and the physician should attempt to reinsert the SCOOP catheter using a small amount of sterile water-soluble jelly or viscous lidocaine on the catheter tip. If this is not successful after a few minutes, an attempt to pass a SCOOP wire guide should be made. Local anesthetic is not injected since it tends to distort tissues. Prolonged attempts at recovering the tract are not advised, since the wire guide may make numerous false tracts. Prolonged attempts to reestablish a lost tract can cause subcutaneous air. If the tract cannot be recovered, the patient goes home on nasal prongs, and an elective procedure may be scheduled for a later date.

Phase III is the most challenging of the 4 phases, because minor morbidity is most likely to occur at this time, and the patient is learning to adjust to the SCOOP program. A skilled team will anticipate and avoid much of the morbidity, recognize and treat problems which do occur and encourage the patient to ride out Phase III, because the clinical course usually becomes much smoother in Phase IV.

 

PHASE IV:
The Mature Tract

Phase IV Goals

    · Customize cleaning protocol
    · Treat tract problems
    · Pulmonary rehabilitation program
    · Replace disposable supplies
    · Health maintenance visits (HMV)
        -monitor O2 therapy

Phase IV usually begins 10-14 days following the Fast TractTM procedure. A customized cleaning protocol for each patient is desirable, because it takes into consideration liter flow, mucus production, underlying lung disease, the patient’s level of comfort with catheter removal and insertion, and the ability to generate an effective cough. A cleaning routine should include cleaning in place at least twice a day. Cleaning in place is the foundation of care. The frequency may easily be increased or decreased based on the patient’s clinical symptomology. Removal for cleaning can be done as often as twice a day to as little as once a week. Daily or twice daily catheter removal reduces risk of mucus ball formation and is recommended. Patients who do not experience mucus balls may prefer to remove the catheter for cleaning less frequently. A customized cleaning protocol is essential for each patient to maximize safety and efficiency.

Phase IV - Catheter Cleaning Guidelines

    · Cleaning in place
        -clean in place at 8AM, 4PM and prn
        -cleaning frequency may be increased or decreased
        based on the patient’s clinical symptomology
        -feeble or anxious patients may prefer cleaning in place
        -tender tracts - minimize further tract trauma
        -patient preference
    · Removal for cleaning
        -remove catheter as often as twice a day at 8AM
        and 4PM
        -do not remove more than BID
        -remove catheter once a day, every other day or once
        a week based on the patient’s symptomology

Daily or twice daily catheter removal reduces risk
of mucus ball formation and is recommended.

When the patient arrives for the first Phase IV visit, tract maturity is assessed. The patient, seated in the procedure chair with head rest, is interviewed regarding changes in sputum, cough, mucus balls, dyspnea, wheezing or any tract problems. Vital signs are taken; body weight and pedal edema are assessed, and a resting oxygen saturation is checked. The tract opening is evaluated for erythema, granulation tissue, induration or any residual air leak. The bead chain necklace is observed for appropriate fit.

A new appropriate SCOOP catheter is prepared by placing a small amount of water-soluble lubricant on the catheter tip, and the bead chain necklace is threaded through the flange. The patient is given facial tissues and warned of incipient cough. Two cc of 1% lidocaine are injected into the SCOOP catheter. After a 1 minute wait, the SCOOP catheter is removed over the wire guide assessing tract maturity during removal and reinsertion. Remove the wire guide and insert the new SCOOP catheter. If the catheter slips easily into place, there is no difficulty with the external opening lining up with the internal tract, and the tract is not too wide and gaping, the tract is defined as mature, and the patient can be advanced to Phase IV. If the physician or respiratory therapist has any difficulty with the aforementioned, or if the patient is not psychologically prepared for daily catheter exchange, the patient will remain in Phase III for 1 or 2 more weeks.

If the tract is not mature or if the patient is not psychologically ready, reinsert the SCOOP catheter and have the patient continue cleaning in place. Secure the bead chain necklace, making sure the SCOOP logo is upright and readable, and retape each side of the flange. Make an appointment for the patient to return in 1 week for a Phase IV re-evaluation.

For the patient who proceeds onto Phase IV, reassess oxygen flow rate by oximetry titration at rest and with exertion. Have the patient view the “Removal for Cleaning” segment in the SCOOP Patient Training video. The patient should then demonstrate the “Removal for Cleaning” sequence using the second catheter.

Helpful tips for the patient include the following suggestions: Hold the catheter at the tip within the last inch so that it gives more control during insertion. Insert the catheter straight back and not at an angle. It should follow the tract’s path and slip easily into place. Twirl the catheter when inserting. Some coughing is normal during insertion. If coughing occurs, continue advancing the catheter. Do not to force the catheter in, because once the catheter is inserted, the coughing should subside.

Remind the patient about occasional cephalad catheter displacement. Sometimes the catheter is displaced in an upward direction. When this happens, the catheter is placed through the vocal cords. This causes a very uncomfortable feeling and a severe continuous cough, and the patient may be unable to talk. This can happen for several reasons. The catheter might have been angled slightly upward instead of straight back, or a strong cough at the time of insertion may have angled the catheter upward. If this occurs, gently remove the catheter and focus on directing the catheter straight back, at which point the catheter should follow the tract path and slip easily into place. The coughing will subside, and the patient’s speaking voice will return.

Customize the patient’s cleaning and changing protocol according to clinical course as well as his or her ease with catheter change. The patient should clean and/or change the catheter BID. Encourage the patient to do the cleaning and changing protocols between 8:00AM and 4:00PM, so that if any questions or problems arise, it would be easier to get in touch with a knowledgeable respiratory therapist, physician or nurse.

There are several suggested customized cleaning protocols. Patients may remove the SCOOP catheter once a day and clean in place once a day. Some patients may choose to remove the catheter 3 times a week with BID cleaning in place on the other days. Other patients who have very little mucus production or are anxious may choose to only remove the catheter once or twice a week with cleaning in place the rest of the time.

Cleaning in excess of BID should always be done using the “in place” method. Excessive removal and reinsertion may traumatize the tract and result in tenderness or chondritis.

There is a great deal of flexibility built into the SCOOP program of care. The physician or transtracheal team member will customize a cleaning program that meets the patient’s specific cleaning needs. Review the Ten SCOOP Rules and the Phase IV instructions with the patient. An appointment will be made for the patient to return in one month. Make sure the patient is told to contact the physician with questions or problems.

A follow-up call to the patient is advisable after a few days to ensure that all is going smoothly and to offer support and encouragement.

Hereafter, the clinical course is usually smooth, and emphasis can be placed on optimizing oxygen therapy and pulmonary rehabilitation. Many patients can be enrolled in pulmonary rehabilitation programs to exploit the superior exercise tolerance and mobility offered by the transtracheal oxygen program.

Health Maintenance Visits (HMV)

    · Three month intervals
    · Interval history and physical exam
        -activity level (SAL)
        -cough, sputum, dyspnea, wheezing
        -appearance of tract
        -chest exam
        -peripheral edema
        -check necklace fitting
    · Laboratory evaluations
        -hematocrit
        -resting oximetry
        -exercise oximetry
        -arterial blood gas (annual HMV)
        -PA and lateral CXR (annual HMV)
    · Replacement of supplies
        -patient contacts DME for replacement of 2 SCOOP catheters and a hose every 90 days per recommended replacement protocol

No universal standards exist for monitoring long-term continuous oxygen therapy. The SCOOP program has found regular health maintenance visits (HMV) every 3 months helpful in optimizing oxygen therapy. Frequent brief check-ups seem to be cost effective in avoiding hositalizations which are expensive. The content of the health maintenance visits is noted above.

Although the Fast TractTM procedure reduces the incidence of tract problems, it is important to be able to identify and treat the problems appropriately. A variety of tract problems may be seen during Phase IV. Erythema may be caused by maceration, abrasion, granulation tissue, contact hyper-sensitivity, Candida albicans and bacterial cellulitis. Maceration and abrasion may result from a necklace which is too tight or a tightly buttoned collar. A cuff of granulation tissue may be seen in some patients. Granulation tissue is a bright red and friable mass of capillaries, fibroblasts and inflammatory cells. In the event that the granulation tissue is exuberant and is associated with minor bleeding, simple cautery with an AgNO3 stick or excision and cautery will correct the problem. Candida is usually an iatrogenic complication from broad spectrum antibiotic ointments. Other factors which predispose to Candida include oral steroids, oral antibiotics and diabetes mellitus. The best protection against Candida is a clean dry tract. Contact hyper-sensitivity can occur with chlorhexidine residues on the catheter and other substances which the patient may be applying to the tract. The catheter should only be cleaned with antibacterial soap. Bacterial cellulitis is especially uncommon but would be treated with antibiotics. Tracheal chrondritis is a special problem which merits further explanation.

Cartilage is a unique tissue, because it is less vascular and has a tendency to become colonized by bacteria and behave like a foreign body. The reader is reminded of the earlier discussion justifying the prolonged use of antibiotic prophylaxis around the time of the procedure. Clinically, about 10% of patients develop a deep indurated lump around the tract several weeks after the procedure. The lump is often tender but is not fluctuant as an abscess would be. The bacteriology is unclear, but the knot appears to be a regional inflammatory response to colonization of exposed tracheal cartilage. Treatment with oral antibiotics, such as Cipro or Keflex 250 mg TID-QID (or a newer antibiotic of choice effective against Staphyloccus aureus), for an additional 3 weeks is usually effective.

Late tract problems may appear months or years following the procedure. Abrasion, maceration, contact hyper-sensitivity and Candida albicans are uncommon, because the patient has usually learned proper tract care by this time. Problematic scar tissue develops in about 5% of patients and causes problems inserting the catheter or visible keloids. Visible keloids differ from granulation tissue because of their late appearance (pink rather than red color and keratinized surface). Factors which appear to result in excessive scar tissue include cricothyroid membrane punctures, exposure of cartilage during the procedure, excessive catheter removal for cleaning (>BID) and patient predisposition. Keloids and chronic tract problems at the level of the cricothyroid membrane are managed by revising the procedure at a lower site. Small keloids at lower puncture sites sometimes respond to repeated injection of small amounts of depo-steroid (e.g. Kenalog, Depomedrol) directly into the keloid. The Fast TractTM procedure is useful as both a primary method of tract creation and a revision procedure for tract problems already incurred with the needle wire guide technique. Large keloids and chronic tract problems which do not respond to simpler methods may be successfully treated with the Fast TractTM procedure. Virtually all patients who have been on TTO long enough to develop complications will elect to have the Fast TractTM procedure rather than return to nasal prongs.

Summary of Transtracheal Tract Problems

    Problems                                                        Treatment
    Maceration                                                      Adjust necklace
    Abrasion                                                          Adjust necklace
    Granulation tissue                                             AgNO3 cautery
    Contact hyper-sensitivity                                  Avoid “lotions & potions”
    Candida albicans                                              Avoid antibiotic ointment
    Cellulitis                                                           Antibiotic
    Tracheal chondritis                                           Antibiotics (3 weeks)

Patients will be reassured to know that if improvement of their medical condition allows discontinuation of transtracheal oxygen therapy, the Fast TractTM procedure may be reversed. In most cases, removal of the SCOOP catheter and placement of a light dressing over the tract will lead to complete closure of the tract in a period of a few days.

If the tract does not completely close, surgical closure can be performed in the operating room under local anesthetic and monitored anesthetic care. Lidocaine 1% with epinepherine 1:100,000 is infiltrated around the remaining tracheocutaneous tract. Cutting cautery is used to completely resect the epithelial connection between the trachea and the skin. The strap muscles and subcutaneous tissue are mobilized and reapproximated at the midline with interrupted absorbable sutures, such as 3-0 Vicryl. After subcuticular skin closure, steristrips are placed. This procedure can be performed on an outpatient basis. Cosmetic revision of depressed tract scars can be performed in a similar manner.

In summary, SCOOP® transtracheal oxygen therapy offers the typical oxygen patient many benefits over conventional nasal prongs and is the best method for delivering ambulatory oxygen therapy 24 hours per day. This booklet summarizes the current Fast TractTM SCOOP® program and addresses of most of the problems encountered earlier in the evolution of this new technology.

For additional copies of this guide or for ordering information concerning SCOOP transtracheal products, call or write to:

Transtracheal Systems, Inc.
109 Inverness Drive East, Suite J
Englewood, Colorado 80112-5105
Ph: 303-790-4766 Fax: 303-790-4588
www.tto2.com

 

© 1997-2001 Transtracheal Systems Part No. 80154 Rev. D 08/01