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Assessment of Cough Reflex in Lung Transplant Recipients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier:
NCT00584077
First received: December 20, 2007
Last updated: August 24, 2015
Last verified: July 2013
  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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: December 20, 2007
Results First Received: July 3, 2013
Last Updated: August 24, 2015
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on December 02, 2016