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Assessment of Cough Reflex in Lung Transplant Recipients

This study is currently recruiting participants.
Verified February 2012 by The University of Texas, Galveston
Sponsor:
Information provided by (Responsible Party):
The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT00584077
First received: December 20, 2007
Last updated: February 21, 2012
Last verified: February 2012
History of Changes
  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 Transplantion

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

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Estimated Enrollment: 36
Study Start Date: April 2000
Estimated Study Completion Date: September 2012
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: The University of Texas, Galveston
ClinicalTrials.gov Identifier: NCT00584077     History of Changes
Other Study ID Numbers: 00-132
Study First Received: December 20, 2007
Last Updated: February 21, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on June 18, 2013