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Carbon Monoxide Monitoring and Emergency Treatment (COMET)

Primary Purpose

Carbon Monoxide Poisoning

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuous Positive Airway Pressure
Non-rebreather oxygen mask
Sponsored by
University of Vermont
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carbon Monoxide Poisoning focused on measuring Carbon Monoxide Toxicity, Carbon, Monoxide, Poisoning, Toxicity, Treatment, CPAP, Hyperbaric, Oxygen

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fletcher Allen Health CareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Participants in this arm are treated with Continuous Positive Airway Pressure at 5cm H2O and 100% oxygen

Participants in this arm receive standard of care therapy- oxygen via a non-rebreather mask

Outcomes

Primary Outcome Measures

Half life of Carboxyhemoglobin

Secondary Outcome Measures

Full Information

First Posted
February 10, 2009
Last Updated
April 1, 2010
Sponsor
University of Vermont
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1. Study Identification

Unique Protocol Identification Number
NCT00841165
Brief Title
Carbon Monoxide Monitoring and Emergency Treatment
Acronym
COMET
Official Title
Randomized Trial of Carbon Monoxide Elimination Kinetics With Oxygen Delivered by Continuous Positive Airway Pressure Compared to Face Mask
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
June 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Vermont

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carbon Monoxide Poisoning
Keywords
Carbon Monoxide Toxicity, Carbon, Monoxide, Poisoning, Toxicity, Treatment, CPAP, Hyperbaric, Oxygen

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants in this arm are treated with Continuous Positive Airway Pressure at 5cm H2O and 100% oxygen
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants in this arm receive standard of care therapy- oxygen via a non-rebreather mask
Intervention Type
Device
Intervention Name(s)
Continuous Positive Airway Pressure
Intervention Description
Full face CPAP at 5cm H2O and 100% oxygen
Intervention Type
Device
Intervention Name(s)
Non-rebreather oxygen mask
Intervention Description
Oxygen administered through a non-rebreather mask
Primary Outcome Measure Information:
Title
Half life of Carboxyhemoglobin
Time Frame
Every 15 minutes during treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tyler J Lemay, BFA
Email
tyler.lemay@uvm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kalev Freeman, MD PhD
Email
kalev.freeman@uvm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kalev Freeman, MD, PhD
Organizational Affiliation
University of Vermont
Official's Role
Study Director
Facility Information:
Facility Name
Fletcher Allen Health Care
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tyler J Lemay, BFA

12. IPD Sharing Statement

Citations:
PubMed Identifier
16339350
Citation
Bruce MC, Bruce EN. Analysis of factors that influence rates of carbon monoxide uptake, distribution, and washout from blood and extravascular tissues using a multicompartment model. J Appl Physiol (1985). 2006 Apr;100(4):1171-80. doi: 10.1152/japplphysiol.00512.2005. Epub 2005 Dec 8.
Results Reference
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PubMed Identifier
12754170
Citation
Bruce EN, Bruce MC. A multicompartment model of carboxyhemoglobin and carboxymyoglobin responses to inhalation of carbon monoxide. J Appl Physiol (1985). 2003 Sep;95(3):1235-47. doi: 10.1152/japplphysiol.00217.2003. Epub 2003 May 16.
Results Reference
background
PubMed Identifier
19297574
Citation
Weaver LK. Clinical practice. Carbon monoxide poisoning. N Engl J Med. 2009 Mar 19;360(12):1217-25. doi: 10.1056/NEJMcp0808891. No abstract available.
Results Reference
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Carbon Monoxide Monitoring and Emergency Treatment

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