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CompletedNCT01126047

Exhaled Carbon Monoxide (eCO) for Diffusing Capacity (DLCO) Correction

Validation of Exhaled Carbon Monoxide for DLCO Correction

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
100 (actual)
Sponsor
University of California, Los Angeles · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

The purpose of this study is to check the accuracy of a procedure called exhaled carbon monoxide (eCO) testing. Exhaled carbon monoxide is used by physicians to help assess breathing in people with conditions like asthma and emphysema. eCO may be used to correct another breathing test (called diffusing capacity, or DLCO). Blood collection is usually required to correct the DLCO, so validation of the eCO test may help avoid that blood collection.

Detailed description

The purpose of this study is to check the accuracy of a procedure called exhaled carbon monoxide (eCO) testing. Exhaled carbon monoxide is used by physicians to help assess breathing in people with conditions like asthma and emphysema. 100 subjects who are at least 18 years of age will be invited to participate. The first 50 subjects (Part 1) must have had pulmonary function testing (spirometry, diffusing capacity and CO-oximetry) for clinical reasons ordered by their own physician in order to enroll. The second 50 subjects (Part 2) may undergo this testing as part of the study. Participation requires 1 visit, during which subjects will undergo breathing tests, have blood collected, and answer 3 questions. The number of breathing tests will depend on which part of the study subjects are in. Subjects participating in Part 1 of the study will undergo 2-4 additional diffusing capacity (breathing) tests. (Clinical tests require 2-4 tests. This study requires 6. The number of research tests done depends on the number of clinical tests done. Subjects participating in Part 2 of the study who have not had clinical breathing tests ordered by their physician will undergo 1 spirometry (breathing) test (3-8 blows into a tube), 6 diffusing capacity (breathing tests), and blood draw. All subjects will undergo eCO testing (blowing into a machine) before the breathing tests and after the breathing tests. The visit in Part 1 of the study will take about 30 minutes. The visit in Part 2 of the study will take about 30 minutes for subjects who have undergone clinical breathing tests recently, and about 1 ½ hours for those who must undergo breathing tests for the research. Subjects will also have their pulse oximetry (using a standard finger clip) performed at the same time as each eCO testing.

Conditions

Interventions

TypeNameDescription
OTHEReCO testingexhaled carbon monoxide testing measured in duplicate on each of 2 machines immediately prior to the carboxyhemoglobin blood draw and four minutes after the clinical measurement of DLCO

Timeline

Start date
2010-05-01
Primary completion
2011-11-01
Completion
2011-11-01
First posted
2010-05-19
Last updated
2011-11-09

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01126047. Inclusion in this directory is not an endorsement.