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

Tracking Information

First Received Date ^ICMJE

December 20, 2007

Last Updated Date

February 21, 2012

Start Date ^ICMJE

April 2000

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00584077 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Assessment of Cough Reflex in Lung Transplant Recipients

Official Title ^ICMJE

Assessment of Cough Reflex in Lung Transplant Recipients

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 (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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Single or double lung or heart-lung transplant recipients

Condition ^ICMJE

Lung Transplantion

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

All enrolled patients receive the same procedures

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

September 2012

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Lung transplant recipient
Hemodynamically stable
Capable of undergoing bronchoscopy

Exclusion Criteria:

Pneumonia
Hypoxemia (PaO2 < 70)
Hemodynamic instability
Coagulopathy
Thrombocytopenia

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Alexander G Duarte, MD

409-772-2436

aduarte@utmb.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00584077

Other Study ID Numbers ^ICMJE

00-132

Has Data Monitoring Committee

Responsible Party

The University of Texas, Galveston

Study Sponsor ^ICMJE

The University of Texas, Galveston

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Alexander G Duarte, MD

University of Texas

Information Provided By

The University of Texas, Galveston

Verification Date

February 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top