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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01762917
First Posted: January 8, 2013
Last Update Posted: January 8, 2013
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.
Information provided by (Responsible Party):
Joachim Saur, University Hospital Mannheim
  Purpose
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).

Condition
Chronic Obstructive Pulmonary Disease Bronchial Asthma Restrictive Pulmonary Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Influence of Bag Volume Variation in Inert Gas Rebreathing Pulmonary Blood Flow Measurements on the Reproducibility in Patients With Pulmonary Diseases

Further study details as provided by Joachim Saur, University Hospital Mannheim:

Primary Outcome Measures:
  • pulmonary blood flow [ Time Frame: 1 day ]
    variation of serial pulmonary blood flow measurements


Enrollment: 45
Study Start Date: September 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Obstruction
Patients suffering from pulmonary obstruction
Restriction
Patients suffering from pulmonary restriction
Controls
Pulmonary healthy controls

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
inpatients and outpatients, internal medicine, university hospital
Criteria

Inclusion Criteria:

  • ability to perform rebreathing maneuver

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

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): NCT01762917


Locations
Germany
University Hospital Mannheim
Mannheim, Germany
Sponsors and Collaborators
Universitätsmedizin Mannheim
  More Information

Responsible Party: Joachim Saur, Principal Investigator, University Hospital Mannheim
ClinicalTrials.gov Identifier: NCT01762917     History of Changes
Other Study ID Numbers: IGR_Vbag_MA
First Submitted: December 21, 2012
First Posted: January 8, 2013
Last Update Posted: January 8, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Asthma
Respiratory Tract Diseases
Bronchial Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases