- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00584077
Assessment of Cough Reflex in Lung Transplant Recipients
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Texas
-
Galveston, Texas, United States, 77555
- University of Texas Medical Branch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Lung transplant recipient
- Hemodynamically stable
- Capable of undergoing bronchoscopy
Exclusion Criteria:
- Pneumonia
- Hypoxemia (PaO2 < 70)
- Hemodynamic instability
- Coagulopathy
- Thrombocytopenia
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Stable lung transplant recipients
All enrolled subjects receive the same procedures; bronchoscopy with administration of mechanical and chemical irritants to the airway mucosa
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Coughs
Time Frame: 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).
|
15-20 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
to Assess the Presence and Strength of the Cough Reflex in the Lower Airway for up to One Year
Time Frame: 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 |
15-20 minutes
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 00-132
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Complication of Transplanted Lung
-
Gary A Levy, O. Ont. MD. FRCP AGAFOttawa Hospital Research InstituteCompletedComplication of Transplanted Organ, NosCanada
-
McGill University Health Centre/Research Institute...UnknownComplication of Transplanted Organ, NosCanada
-
Rigshospitalet, DenmarkKarolinska Institutet; Oslo University Hospital; Helsinki University Central... and other collaboratorsUnknownComplication of Transplanted LiverDenmark, Finland, Norway, Sweden
-
Hospital Vall d'HebronCompletedInfection | Intestinal Microbiota | Complication of Transplanted Liver | Acute Rejection of Liver TransplantSpain
-
Universidad de GuanajuatoHospital Regional de Alta Especialidad del BajioCompletedTransplanted Kidney Complication
-
The Hospital for Sick ChildrenMerck Sharp & Dohme LLC; The Physicians' Services Incorporated FoundationCompletedLate Complication From Kidney Transplant | Complication of Transplanted Liver | Human Papillomavirus-Related CarcinomaCanada
-
Duke UniversityGilead SciencesCompletedComplication of Transplanted LungUnited States
-
Mark StegallMillennium Pharmaceuticals, Inc.TerminatedDisorder of Transplanted KidneyUnited States
-
Oslo University HospitalSouth-Eastern Norway Regional Health AuthorityCompletedDisorder of Transplanted KidneyNorway
-
Northwestern UniversityNorthwestern Memorial HospitalCompletedComplication of Transplanted LiverUnited States