Complication of Transplanted Lung
Conditions
Brief summary
The purpose of this study is to evaluate the presence of cough reflex in the transplanted lung of patients who have had either a single or double lung transplant or heart-lung transplant at University of Texas Medical Branch. At the 1 year post transplant bronchoscopy, the presence of the cough reflex will be assessed by placing 3 to 5 ml of 5% dextrose and placement of the bronchial biopsy forceps on the airway mucosa. Three to four separate areas of the transplanted airways will be assessed. The cough reflex will be assessed by recording the surface electrical activity by placing external electrodes to monitor the movement of abdominal muscles during a cough. The data will be recorded and compared with recordings from coughs recorded using the surface electrical activity of a cough generated by non-transplant patients.
Detailed description
Bronchoscopy Stable, lung transplant recipients undergoing surveillance bronchoscopy will be enrolled. We will exclude subjects with new or persistent cough, hypoxemia, new radiographic infiltrates, or hemodynamic instability. Before bronchoscopy, patients will receive diazepam while codeine and atropine will be withheld. Upper airway anesthesia was performed using cotton swabs soaked with 4 % lidocaine applied on the oropharyngeal mucosa and gradually placed posteriorly with the aid of curved foreceps to anesthetize the supraglottic region. A trained individual will perform topical upper airway anesthesia over 15 minutes and adequate anesthesia will be determined once subjects fail to cough during foreceps application to the supraglottic region. Conscious sedation will be administered using intravenous midazolam while vital signs are monitored. Once adequate sedation is achieved, the bronchoscope will be introduced through the mouth beyond the vocal chords to the main carina and slowly advanced to the airway anastomosis. Coughing that occurs with advancement of the bronchoscope from the chords to the anastomosis will be addressed by maintaining the bronchoscope in an immobile neutral position for 60-180 seconds until coughing stops and the cough provocation will be performed. Cough provocation Airway irritants will be applied in the following sequence: 1) one cm distal to anastomosis, 2) one cm proximal to anastomosis and 3) at the main carina. Chemical irritation will consist of 3 mL aliquots of 5 % dextrose water (D5W) instilled through the bronchoscope channel on the bronchial mucosa (21). Aliquots of D5W will be administered at each site on three separate occasions with a 60 second interval between administrations. Mechanical irritation will involve placement of the biopsy foreceps on the bronchial mucosa at each site. The sequence of airway irritation sites will always begin with the distal anastomosis followed by the proximal anastomosis and main carina. Airway lidocaine administration Patients demonstrating a cough reflex at the distal anastomotic site will be recorded. After measurements are obtained at all airway sites, the bronchoscope will be reintroduced to the distal anastomosis and 3 mL of 4 % lidocaine instilled on the bronchial mucosa. Sixty seconds later, mechanical and chemical irritation of the proximal and distal anastomosis will be performed as previously outlined. Cough assessment Cough frequency will be determined by counting audible coughs and abdominal muscle contractions measured with a surface electromyograph (EMG) recorder. Surface electrodes placed on the skin, 2 cm below each costal margin along the midclavicular line will be connected to an EMG recorder (Biopac Systems Inc, Santa Barbara, CA) linked to a dedicated computer. Continuous EMG recordings will be obtained 15 seconds before administration of the airway irritant to ensure absence of cough before airway irritant administration (Figure 1). Twenty seconds or more of recording will be obtained after airway irritant application. Cough will be defined as abdominal muscle contraction and audible expiratory sound.
Interventions
None listed
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Lung transplant recipient * Hemodynamically stable * Capable of undergoing bronchoscopy
Exclusion criteria
* Pneumonia * Hypoxemia (PaO2 \< 70) * Hemodynamic instability * Coagulopathy * Thrombocytopenia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Coughs | 15-20 minutes | The number of coughs elicited by placement of biopsy forceps or instillation of dextrose solution on the airway mucosa. The presence of the cough reflex will be assessed with administration of mechanical (biopsy foreceps) and chemical (D5W) at the level of the main carina, proximal to airway anastomosis (native airway) and distal to the airway anastomosis (allograft airway). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| to Assess the Presence and Strength of the Cough Reflex in the Lower Airway for up to One Year | 15-20 minutes | Presence of cough as elicited by placement of biopsy forceps or instillation of dextrose solution on the airway mucosa. The presence of the cough reflex will be assessed with administration of mechanical (biopsy foreceps) and chemical (dextrose solution) at the level of the main carina, native lung airway and proximal and distal to the airway anastomosis. Lung transplant recipients underwent airway evaluations using the above protocel at 1.5 and 12 months after lung transplantation. after undergoing transplantation |
Countries
United States
Participant flow
Recruitment details
Subjects scheduled to undergo surveillance bronchoscopy were enrolled
Participants by arm
| Arm | Count |
|---|---|
| Lung Transplant Recipients With Stable Lung Function All enrolled subjects underwent bronchoscopy to determine presence of cough as well as the location of airway eliciting a cough response | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Lung Transplant Recipients With Stable Lung Function |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Age, Continuous Age | 49 years STANDARD_DEVIATION 8 |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Number of Coughs
The number of coughs elicited by placement of biopsy forceps or instillation of dextrose solution on the airway mucosa. The presence of the cough reflex will be assessed with administration of mechanical (biopsy foreceps) and chemical (D5W) at the level of the main carina, proximal to airway anastomosis (native airway) and distal to the airway anastomosis (allograft airway).
Time frame: 15-20 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lung Transplant Recipients With Stable Lung Function | Number of Coughs | 7.3 Coughs | Standard Deviation 5.2 |
Comparison: Each subject served as their own control as a comparison of the airway innervated (contralateral native lung) with the denervated airway (allograft)p-value: <0.01ANOVA
Secondary
to Assess the Presence and Strength of the Cough Reflex in the Lower Airway for up to One Year
Presence of cough as elicited by placement of biopsy forceps or instillation of dextrose solution on the airway mucosa. The presence of the cough reflex will be assessed with administration of mechanical (biopsy foreceps) and chemical (dextrose solution) at the level of the main carina, native lung airway and proximal and distal to the airway anastomosis. Lung transplant recipients underwent airway evaluations using the above protocel at 1.5 and 12 months after lung transplantation. after undergoing transplantation
Time frame: 15-20 minutes
Population: Stable lung transplant recipients
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lung Transplant Recipients With Stable Lung Function | to Assess the Presence and Strength of the Cough Reflex in the Lower Airway for up to One Year | Cough1.5 months with D5W at distal anastomosis | 0.63 Coughs | Standard Deviation 1.2 |
| Lung Transplant Recipients With Stable Lung Function | to Assess the Presence and Strength of the Cough Reflex in the Lower Airway for up to One Year | Cough 12 months with D5W at distal anastomosis | 7.3 Coughs | Standard Deviation 5.2 |
| Lung Transplant Recipients With Stable Lung Function | to Assess the Presence and Strength of the Cough Reflex in the Lower Airway for up to One Year | Cough1.5 months with foreceps atdistal anastomosis | 0.25 Coughs | Standard Deviation 0.46 |
| Lung Transplant Recipients With Stable Lung Function | to Assess the Presence and Strength of the Cough Reflex in the Lower Airway for up to One Year | Cough 12 months with foreceps atdistal anastomosis | 3.0 Coughs | Standard Deviation 2.3 |
Comparison: For the cross-sectional and longitudinal groups, a comparison of cough frequency after airway irritation of the main carina, and the proximal and distal anastomotic sites was performed using one-way analysis of variance with Bonferroni test. In the longitudinal cohort, a comparison of the cough frequencies at different airway sites at 1.5 and 12 months was performed using one-way analysis of variance with Bonferroni test.p-value: <0.01ANOVA