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

NCT01126047 | Completed

• 1 other identifier: eCO
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Lung Diseases

Keywords

Lung Diseases

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

PFT's, eCO, and pulse oximetry

OTHER

All subjects in the study will undergo complete pulmonary function testing (spirometry, blood collection for carboxyhemoglobin, diffusing capacity); exhaled carbon-monoxide testing, and pulse oximetry.

Other: eCO testing

Interventions

eCO testing OTHER

exhaled 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

PFT's, eCO, and pulse oximetry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (2)

UCLA

Los Angeles, California, 90095, United States

Location

West LA VA

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Michelle R Zeidler, MD

  UCLA, VA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 14, 2010
• First Posted: May 19, 2010
• Study Start: May 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: November 9, 2011

Record last verified: 2011-11

Locations

US (2)