Carbon Monoxide Monitoring and Emergency Treatment (COMET)

April 1, 2010 updated by: University of Vermont

Randomized Trial of Carbon Monoxide Elimination Kinetics With Oxygen Delivered by Continuous Positive Airway Pressure Compared to Face Mask

Carbon monoxide (CO) has been called a "silent killer", and those patients who survive CO poisoning are at risk of neurological damage, which may be permanent. CO is a leading cause of unintentional poisoning deaths in the United States, and the odorless gas results in an estimated average of 20,636 emergency department (ED) visits each year. Oxygen is the antidote for CO poisoning, and it acts both by attenuating toxic effects and enhancing elimination. A fractional inspired concentration of oxygen (FiO2) of 0.7 to 0.9 may be achieved by administration of 100% oxygen delivered using a reservoir with a facemask that prevents rebreathing. Hyperbaric oxygen therapy may provide added benefit for patients with CO poisoning, but this therapy is unavailable in many parts of the United States including Vermont. Use of a continuous positive airway pressure (CPAP) mask may achieve an FiO2 of 1.0, but the effects of delivering an FiO2 of 1.0 compared to 0.7 in CO poisoning are unknown. CPAP, by comparison, is inexpensive, portable, and available in most EDs. In this study, the investigators are testing the hypothesis that oxygen delivered by CPAP will improve both CO washout kinetics and functional outcomes, compared to the standard therapy of oxygen delivered by non-rebreathing facemask. Specific Aim 1 will provide toxicokinetic data to support a potential benefit in the use of CPAP for CO poisoning, by comparing CO elimination kinetics in response to oxygen therapy delivered by non-rebreathing facemask versus CPAP. The 20 patients expected in our first year will provide adequate power to detect a 20% fall in half-time of CO elimination. While CPAP may increase CO washout rates, as predicted in Specific Aim 1, demonstration of real functional benefit will be tested in Specific Aim 2. This Aim seeks to determine functional (neuropsychological) outcomes in patients with CO poisoning treated with oxygen therapy delivered by non-rebreathing facemask versus CPAP. Data showing a therapeutic benefit from CPAP in CO poisoning would have clinical implications. Compared to hyperbaric oxygen therapy, CPAP therapy can begin earlier, including the pre-hospital setting, for patients with known exposure. With the frequent nature of CO poisoning and the widespread availability of CPAP, a potential benefit could lead to improved outcomes for the 20,000+ patients who present to EDs annually.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Recruiting
        • Fletcher Allen Health Care
        • Principal Investigator:
          • Tyler J Lemay, BFA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Elevated Carboxyhemoglobin Level (non-smokers >8%, smokers >12%)
  • 18 years of age or older
  • Able to provide informed consent as assessed by Attending Emergency Physician

Exclusion Criteria:

  • Requires daily medication for active lung disease
  • Altered mental status
  • Hemodynamically unstable
  • Requires transfer to ICU or hyperbaric oxygen facility
  • Previous enrollment in the study
  • No concurrent acute psychiatric illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Participants in this arm are treated with Continuous Positive Airway Pressure at 5cm H2O and 100% oxygen
Device: Continuous Positive Airway Pressure
Full face CPAP at 5cm H2O and 100% oxygen
Active Comparator: 2
Participants in this arm receive standard of care therapy- oxygen via a non-rebreather mask
Device: Non-rebreather oxygen mask
Oxygen administered through a non-rebreather mask

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Half life of Carboxyhemoglobin
Time Frame: Every 15 minutes during treatment
Every 15 minutes during treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Vermont

Investigators

  • Study Director: Kalev Freeman, MD, PhD, University of Vermont

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Anticipated)

June 1, 2010

Study Completion (Anticipated)

June 1, 2010

Study Registration Dates

First Submitted

February 10, 2009

First Submitted That Met QC Criteria

February 10, 2009

First Posted (Estimate)

February 11, 2009

Study Record Updates

Last Update Posted (Estimate)

April 2, 2010

Last Update Submitted That Met QC Criteria

April 1, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHRMS 09-056

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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