Recruiting

Carbon Monoxide

Sponsor:

University of Vermont

Code:

NCT00841165

Conditions

Carbon Monoxide Poisoning

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Continuous Positive Airway Pressure

Non-rebreather oxygen mask

Study Details

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.

Conditions

Carbon Monoxide Poisoning

Study ID

NCT00841165

Start date

Jan, 2009

Status verified date

Apr, 2010

Completion date

Jun, 2010

Anticipated

Primary completion date

Jun, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 1

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

active comparator: 2

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

Interventions

Continuous Positive Airway Pressure

Full face CPAP at 5cm H2O and 100% oxygen

Non-rebreather oxygen mask

Oxygen administered through a non-rebreather mask

Primary outcome measure

  • Half life of Carboxyhemoglobin [ Time Frame: Every 15 minutes during treatment ]

Central Contacts and Locations

Central contacts

Tyler J Lemay, BFA

tyler.lemay@uvm.edu

Kalev Freeman, MD PhD

kalev.freeman@uvm.edu

Locations

Fletcher Allen Health Care

Recruiting

Burlington, Vermont, United States, 05401

Principal Investigator:

Tyler J Lemay, BFA

More Information

Sponsor

University of Vermont

Last update posted

Apr 2, 2010

Last verified

Apr, 2010

Keywords

  • Carbon Monoxide Toxicity
  • Carbon
  • Monoxide
  • Poisoning
  • Toxicity
  • Treatment
  • CPAP
  • Hyperbaric
  • Oxygen

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Vermont on 2010-04-02.