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Assessment of Cough Reflex in Lung Transplant Recipients

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.
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):

December 20, 2007
January 2, 2008
July 3, 2013
September 25, 2015
September 25, 2015
April 2000
October 2006   (Final data collection date for primary outcome measure)
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.
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 ]
Complete list of historical versions of study NCT00584077 on ClinicalTrials.gov Archive Site
to Assess the Presence and Strength of the Cough Reflex in the Lower Airway for up to One Year [ Time Frame: 15-20 minutes ]
Same as current
Not Provided
Not Provided
 
Assessment of Cough Reflex in Lung Transplant Recipients
Assessment of Cough Reflex in Lung Transplant Recipients
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample
Single or double lung or heart-lung transplant recipients
Complication of Transplanted Lung
Not Provided
Stable lung transplant recipients
All enrolled subjects receive the same procedures; bronchoscopy with administration of mechanical and chemical irritants to the airway mucosa
Duarte AG, Terminella L, Smith JT, Myers AC, Campbell G, Lick S. Restoration of cough reflex in lung transplant recipients. Chest. 2008 Aug;134(2):310-316. doi: 10.1378/chest.07-2934. Epub 2008 Mar 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
October 2007
October 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Pneumonia
  • Hypoxemia (PaO2 < 70)
  • Hemodynamic instability
  • Coagulopathy
  • Thrombocytopenia
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00584077
00-132
No
Not Provided
Not Provided
The University of Texas Medical Branch, Galveston
The University of Texas Medical Branch, Galveston
Not Provided
Principal Investigator: Alexander G Duarte, MD University of Texas
The University of Texas Medical Branch, Galveston
July 2013