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

Primary Purpose

Lung Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
eCO testing
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Diseases focused on measuring Lung Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • UCLA
  • West LA VA

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

PFT's, eCO, and pulse oximetry

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 14, 2010
Last Updated
November 7, 2011
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT01126047
Brief Title
Exhaled Carbon Monoxide (eCO) for Diffusing Capacity (DLCO) Correction
Official Title
Validation of Exhaled Carbon Monoxide for DLCO Correction
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases
Keywords
Lung Diseases

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PFT's, eCO, and pulse oximetry
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
eCO testing
Intervention Description
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
Primary Outcome Measure Information:
Title
Exhaled carbon monoxide as a predictor of carboxyhemoglobin
Description
Exhaled carbon monoxide will be evaluated as a predictor of carboxyhemoglobin and change in diffusing capacity with increasing carboxyhemoglobin
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle R Zeidler, MD
Organizational Affiliation
UCLA, VA
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
West LA VA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

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

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