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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01126047
• Date of registration: 14/05/2010
• Primary sponsor: University of California, Los Angeles
• Public title: Exhaled Carbon Monoxide (eCO) for Diffusing Capacity (DLCO) Correction
• Scientific title: Validation of Exhaled Carbon Monoxide for DLCO Correction
• Date of first enrolment: May 2010
• Target sample size: 100
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01126047
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Countries of recruitment

United States

Contacts

• Name: Michelle R Zeidler, MD
• Affiliation: UCLA, VA

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Lung Diseases

Intervention(s)

Other: eCO testing

Primary Outcome(s)

Exhaled carbon monoxide as a predictor of carboxyhemoglobin [Time Frame: 1 year]

Secondary ID(s)

eCO

Source(s) of Monetary Support

Please refer to primary and secondary sponsors