Single-Breath Measurement Underestimates Ventilatory Volume According to Emphysema Severity

This study has been completed.

Sponsor:

Information provided by:

Columbia University

ClinicalTrials.gov Identifier:

NCT00528944

First received: September 11, 2007

Last updated: January 28, 2011

Last verified: January 2011

History of Changes

Purpose

Although single breath helium (He) dilution measurement (VASB) is currently used in pulmonary function laboratories to assess functional alveolar volume and diffusing capacity for carbon monoxide, the extent to which VASB reflects ventilatory and thoracic volume has not been prospectively determined in emphysema. We hypothesized that VASB underestimates rebreathe helium dilution volume (VARB), and plethysmographic volume (VApleth) as clinical and physiologic severity of emphysema increases.

Condition
Emphysema

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Single-Breath Measurement Underestimates Ventilatory Volume According to Emphysema Severity

Resource links provided by NLM:

MedlinePlus related topics: Emphysema

U.S. FDA Resources

Further study details as provided by Columbia University:

Enrollment:	104
Study Start Date:	January 2006
Study Completion Date:	July 2007

Groups/Cohorts
Cohort A Patients with obstructive defects and radiological evidence of emphysema
Cohort B Patients with obstructive ventilatory defects and no radiological evidence of emphysema
Cohort C Non-smokers without obstructive ventilatory defects or history of cardiopulmonary disease

Detailed Description:

VASB, VARB, and VApleth were measured in 52 consecutive stable outpatients with clinical and radiographic emphysema. Thirteen patients with an obstructive ventilatory defect without emphysema (OVD) and 18 normal controls were similarly studied. All subjects underwent spirometry followed by whole body plethysmography and He dilution volume measurements; VASB and VARB order was randomized.

Eligibility

Ages Eligible for Study:	18 Years to 81 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

This is a prospective trial in all outpatients with emphysema referred for full pulmonary function testing to the pulmonary diagnostic unit.

Criteria

Inclusion Criteria:

All outpatients between the ages of 18 and 81 years referred to the Columbia University Medical Center Pulmonary Diagnostic Unit between 1/18/06 and 7/30/07 for full pulmonary function evaluation, and with an obstructive ventilatory defect on spirometry, were considered eligible.

Exclusion Criteria:

Patients who did not want to undergo the re-breathe diffusing capacity testing
Patients who could not give informed consent;and
Patients who were too physically compromised to undergo full testing including the re-breathe maneuver as deemed by our technicians.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00528944

Locations

United States, New York
Columbia University Cardiopulmonary, Sleep and Ventilatory Disorders Center
NY, New York, United States, 10032

Sponsors and Collaborators

Columbia University

Investigators

Principal Investigator:

Robert C Basner, MD

Columbia University

More Information

No publications provided

Responsible Party:	Robert C Basner, MD, Columbia University Medical Center
ClinicalTrials.gov Identifier:	NCT00528944 History of Changes
Other Study ID Numbers:	AAAB6328
Study First Received:	September 11, 2007
Last Updated:	January 28, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Columbia University:

alveolar volume
pulmonary function testing
emphysema

Additional relevant MeSH terms:

Emphysema
Pulmonary Emphysema
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 22, 2013

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