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Assessment of Cough Reflex in Lung Transplant Recipients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00584077
First Posted: January 2, 2008
Last Update Posted: September 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston
  Purpose
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 teh 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.

Condition
Complication of Transplanted Lung

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Assessment of Cough Reflex in Lung Transplant Recipients

Resource links provided by NLM:


Further study details as provided by The University of Texas Medical Branch, Galveston:

Primary Outcome Measures:
  • Evaluate the Presence and Strength of the Cough Reflex in the Lower Airway [ 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 administartion of mecahnical (Biopsy foreceps) and chemical (dextrose solution) at the level of the main carina, native lung airway and proximal and distal to the airway anastomosis.


Secondary Outcome Measures:
  • to Assess the Presence and Strength of the Cough Reflex in the Lower Airway for up to One Year [ Time Frame: 15-20 minutes ]

Enrollment: 15
Study Start Date: April 2000
Study Completion Date: October 2007
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts
Stable lung transplant recipients
All enrolled subjects receive the same procedures; bronchoscopy with administration of mechanical and chemical irritants to the airway mucosa

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Single or double lung or heart-lung transplant recipients
Criteria

Inclusion Criteria:

  • Lung transplant recipient
  • Hemodynamically stable
  • Capable of undergoing bronchoscopy

Exclusion Criteria:

  • Pneumonia
  • Hypoxemia (PaO2 < 70)
  • Hemodynamic instability
  • Coagulopathy
  • Thrombocytopenia
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00584077


Locations
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Investigators
Principal Investigator: Alexander G Duarte, MD University of Texas
  More Information

Publications:
Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT00584077     History of Changes
Other Study ID Numbers: 00-132
First Submitted: December 20, 2007
First Posted: January 2, 2008
Results First Submitted: July 3, 2013
Results First Posted: September 25, 2015
Last Update Posted: September 25, 2015
Last Verified: July 2013