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Assessment of Cough Reflex in Lung Transplant Recipients

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ClinicalTrials.gov Identifier: NCT00584077
Recruitment Status : Completed
First Posted : January 2, 2008
Results First Posted : September 25, 2015
Last Update Posted : September 25, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Complication of Transplanted Lung

Study Design

Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Assessment of Cough Reflex in Lung Transplant Recipients
Study Start Date : April 2000
Primary Completion Date : October 2006
Study Completion Date : October 2007

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U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. to Assess the Presence and Strength of the Cough Reflex in the Lower Airway for up to One Year [ Time Frame: 15-20 minutes ]

Eligibility Criteria

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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

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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 Posted: January 2, 2008    Key Record Dates
Results First Posted: September 25, 2015
Last Update Posted: September 25, 2015
Last Verified: July 2013