Lung Diseases Clinical Trial
Official title:
Validation of Exhaled Carbon Monoxide for DLCO Correction
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | November 2011 |
Est. primary completion date | November 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients who will at minimum have spirometry, diffusing capacity and CO-oximetry performed for any clinical indication (Part 1 only) - Willingness to under go the study procedures. - Ability to give written informed consent to participate in the study. Exclusion Criteria: - Subjects on oxygen therapy within 1 hour. High levels of oxygen are used to displace CO in cases of toxicity. Presumably those recently on lower flows of oxygen are not in a steady state for several half-lives. - Self-reported smoking within 1-hour. - Significant exercise within 15 minutes - Recent (within 2 hrs) alcohol consumption (alcohol can interfere with the DLCO measurement) - Subjects unwilling to remove nail polish from one finger - Known atypical hemoglobin types (e.g. sickle cell trait or disease, thalassemia etc). The binding and release of oxygen and presumably CO is altered in these types of hemoglobinopathies - History of known or suspected alveolar hemorrhage. Free hemoglobin or red cells in the alveolus markedly raise the DLCO and theoretically might alter the eCO. - Known or suspected intestinal bacterial overgrowth. Although the cross reactivity of the CO sensor for hydrogen is <2%, high values of hydrogen from bacterial overgrowth, may lead to erroneous CO measurements. - Tracheostomy or inability to form a tight seal around the mouthpiece. - Prior participation in the same part of this study (i.e., subjects can participate in Part 1 and Part 2, but not twice in Part 1, or twice in Part 2) - Inability to perform spirometry and diffusing capacity - Inability to consent - Other diseases or conditions that may, in the opinion of the investigator, result in invalid pulmonary function tests or eCO measurement. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | UCLA | Los Angeles | California |
United States | West LA VA | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Exhaled carbon monoxide as a predictor of carboxyhemoglobin | Exhaled carbon monoxide will be evaluated as a predictor of carboxyhemoglobin and change in diffusing capacity with increasing carboxyhemoglobin | 1 year | No |
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