Carbon Monoxide Monitoring and Emergency Treatment (COMET)
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Carbon Monoxide Poisoning |
Device: Continuous Positive Airway Pressure Device: Non-rebreather oxygen mask |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Randomized Trial of Carbon Monoxide Elimination Kinetics With Oxygen Delivered by Continuous Positive Airway Pressure Compared to Face Mask |
- Half life of Carboxyhemoglobin [ Time Frame: Every 15 minutes during treatment ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Tyler J Lemay, BFA | tyler.lemay@uvm.edu | |
| Contact: Kalev Freeman, MD PhD | kalev.freeman@uvm.edu |
| United States, Vermont | |
| Fletcher Allen Health Care | Recruiting |
| Burlington, Vermont, United States, 05401 | |
| Principal Investigator: Tyler J Lemay, BFA | |
| Study Director: | Kalev Freeman, MD, PhD | University of Vermont |
More Information
Publications:
| Responsible Party: | Dr. Kalev Freeman, Faculty Sponsor, Department of Surgery, University of Vermont |
| ClinicalTrials.gov Identifier: | NCT00841165 History of Changes |
| Other Study ID Numbers: | CHRMS 09-056 |
| Study First Received: | February 10, 2009 |
| Last Updated: | April 1, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Vermont:
|
Carbon Monoxide Toxicity Carbon Monoxide Poisoning Toxicity |
Treatment CPAP Hyperbaric Oxygen |
Additional relevant MeSH terms:
|
Carbon Monoxide Poisoning Poisoning Gas Poisoning Substance-Related Disorders |
Carbon Monoxide Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013