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NCT01762917 Clinical Trial

Influence of Bag Volume Variation on the Reproducibility of Inert Gas Rebreathing

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:
Influence of Bag Volume Variation in Inert Gas Rebreathing Pulmonary Blood Flow Measurements on the Reproducibility in Patients With Pulmonary Diseases

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01762917
Other study ID # IGR_Vbag_MA
Secondary ID
Status Completed
Phase N/A
First received December 21, 2012
Last updated January 7, 2013
Start date September 2007
Est. completion date December 2010

Study information
Verified date January 2013
Source Universitätsmedizin Mannheim
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

Non-invasive inert gas rebreathing (IGR) based on the Fick Principle showed promising results in the determination of pulmonary blood flow (PBF). The volume of the rebreathing bag (Vbag) is proposed by the system, however, elderly patients or those suffering from high grade pulmonary diseases might be unable to entirely rebreathe this volume and therefore fail to completely mix the test gases. The aim of our study is to evaluate the effect of adapting Vbag on the reproducibility of IGR measurements in patients with obstruction (group A), restriction (group B) and pulmonary healthy controls (group C).

Recruitment information / eligibility
Status Completed
Enrollment 45
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- ability to perform rebreathing maneuver

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Germany University Hospital Mannheim Mannheim

Sponsors (1)
Lead Sponsor Collaborator
Universitätsmedizin Mannheim

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary pulmonary blood flow variation of serial pulmonary blood flow measurements 1 day No
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