Carbon Monoxide PoisoningCOMETNCT00841165
Carbon Monoxide Monitoring and Emergency Treatment
A study testing Continuous Positive Airway Pressure and Non-rebreather oxygen mask in people with Carbon Monoxide Poisoning, run by University of Vermont at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carbon Monoxide Poisoning
- What is being tested?
- Continuous Positive Airway Pressure and Non-rebreather oxygen mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Tyler J Lemay, BFA contact
Kalev Freeman, MD PhD contact
United States1 site, 1 recruiting
- Recruiting
Fletcher Allen Health Care
Burlington, Vermont, 05401
Tyler J Lemay, BFA
About this study
Official title: 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.
- Conditions
- Carbon Monoxide Poisoning
- Being tested
- Continuous Positive Airway Pressure, Non-rebreather oxygen mask
- Keywords
- Carbon Monoxide Toxicity, Carbon, Monoxide, Poisoning, Toxicity, Treatment, CPAP, Hyperbaric, Oxygen
- Medical subject headings
- Carbon Monoxide Poisoning, Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Positive Airway PressureDevice
Full face CPAP at 5cm H2O and 100% oxygen
Non-rebreather oxygen maskDevice
Oxygen administered through a non-rebreather mask
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants in this arm are treated with Continuous Positive Airway Pressure at 5cm H2O and 100% oxygen Receives: Device: Continuous Positive Airway Pressure |
| 2 | Active comparator | Participants in this arm receive standard of care therapy- oxygen via a non-rebreather mask Receives: Device: Non-rebreather oxygen mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Half life of Carboxyhemoglobin
Measured: Every 15 minutes during treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionJun 2010 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Carbon Monoxide PoisoningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Investigators
- Kalev Freeman, MD, PhD, Study director, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00841165
- Sponsor's protocol ID
- CHRMS 09-056
- Acronym
- COMET
- Status last verified
- Apr 2010
- First submitted
- 10 Feb 2009
- Last updated
- 2 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16339350Bruce 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.
PubMed 12754170Weaver LK. Clinical practice. Carbon monoxide poisoning. N Engl J Med. 2009 Mar 19;360(12):1217-25. doi: 10.1056/NEJMcp0808891. No abstract available.
PubMed 19297574
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Carbon Monoxide Elimination Kinetics With Oxygen Delivered by Continuous Positive Airway Pressure Compared to Face Mask
- ClinicalTrials.gov ID
- NCT00841165
- Acronym / sponsor ID
- COMET / CHRMS 09-056
- Conditions
- Carbon Monoxide Poisoning
- Keywords
- Carbon Monoxide Toxicity, Carbon, Monoxide, Poisoning, Toxicity, Treatment, CPAP, Hyperbaric
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 11 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Continuous Positive Airway PressureParticipants in this arm are treated with Continuous Positive Airway Pressure at 5cm H2O and 100% oxygen |
| 2 | Active comparator | Device: Non-rebreather oxygen maskParticipants in this arm receive standard of care therapy- oxygen via a non-rebreather mask |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Positive Airway PressureFull face CPAP at 5cm H2O and 100% oxygen | Device | 1 |
| Non-rebreather oxygen maskOxygen administered through a non-rebreather mask | Device | 2 |
Primary outcome
Half life of Carboxyhemoglobin
Time frame: Every 15 minutes during treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2010.
- Background: PubMed 16339350Bruce 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.
- Background: PubMed 12754170Bruce 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.
- Background: PubMed 19297574Weaver LK. Clinical practice. Carbon monoxide poisoning. N Engl J Med. 2009 Mar 19;360(12):1217-25. doi: 10.1056/NEJMcp0808891. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tyler J Lemay, BFA contact
Kalev Freeman, MD PhD contact
Kalev Freeman, MD, PhD study director
University of Vermont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Positive Airway Pressure and Non-rebreather oxygen mask in people with Carbon Monoxide Poisoning, run by University of Vermont at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tyler J Lemay, BFA (tyler.lemay@uvm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Half life of Carboxyhemoglobin (time frame: Every 15 minutes during treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00841165, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2010.