Assessment of Cough Reflex in Lung Transplant Recipients

This study is currently recruiting participants.

Verified by The University of Texas, Galveston, February 2009

First Received: December 20, 2007 Last Updated: February 12, 2009 History of Changes

Sponsored by:	The University of Texas, Galveston
Information provided by:	The University of Texas, Galveston
ClinicalTrials.gov Identifier:	NCT00584077

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 (sugar water) or mechanical stimulation with standard bronchial biopsy forceps in three separate areas of the transplanted lung(s). 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
Lung Transplantation

MedlinePlus related topics: Cough Lung Transplantation

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Assessment of Cough Reflex in Lung Transplant Recipients

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

Primary Outcome Measures:

to evaluate presence and strength of the cough reflex in the lower airway specifically at the level of the main carina and airway anastomosis through the application of mechanical and chemical stimuli [ Time Frame: 15-20 minutes ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	36
Study Start Date:	April 2000
Estimated Study Completion Date:	December 2009

Groups/Cohorts
A All enrolled patients receive the same procedures

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00584077

Contacts

Contact: Alexander G Duarte, MD

409-772-2436

aduarte@utmb.edu

Locations

United States, Texas
University of Texas Medical Branch	Recruiting
Galveston, Texas, United States, 77555
Contact: Alexander G Duarte, MD 409-772-2436 aduarte@utmb.edu

Sponsors and Collaborators

The University of Texas, Galveston

Investigators

Principal Investigator:

Alexander G Duarte, MD

University of Texas

More Information

No publications provided

Responsible Party:	University of Texas Medical Branch ( Alexander G Duarte, MD )
Study ID Numbers:	00-132
Study First Received:	December 20, 2007
Last Updated:	February 12, 2009
ClinicalTrials.gov Identifier:	NCT00584077 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Cough

ClinicalTrials.gov processed this record on May 07, 2009