Carbon Monoxide PoisoningPhase 41V3CORCTNCT00465855
One vs. Three Hyperbaric Oxygen Treatments for Acute Carbon Monoxide Poisoning
A Phase 4 study testing Hyperbaric Oxygen (HBO2) - 3 sessions and Hyperbaric Oxygen (HBO2) - 1 session in people with Carbon Monoxide Poisoning, run by Intermountain Health Care, Inc. at 2 sites in United States.
Trial summary
This randomized trial will investigate important clinical outcomes of patients with acute carbon monoxide poisoning randomized to receive either one or three hyperbaric oxygen treatments. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Carbon Monoxide Poisoning
- What is being tested?
- Hyperbaric Oxygen (HBO2) - 3 sessions and Hyperbaric Oxygen (HBO2) - 1 session
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Jun 2007to 28 Jan 2017
- Phase
- Phase 4
- 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic CO poisoning (headache, nausea, vomiting, dizziness, fatigue, muscle aches, slowed mentation, confusion, or loss of consciousness).
- Carboxyhemoglobin (COHb) levels > 10% or confirmation of poisoning with ambient levels > 50 ppm in a patient with symptoms compatible with CO poisoning and no other reasonable explanation for their signs and symptoms.
- Less than 24 hours from removal from the source of CO exposure and study enrollment.
- Accidental poisoning
Who cannot join
- Pregnancy
- Age < 18 years or > 79 years
- Complication during first hyperbaric oxygen session precluding subsequent hyperbaric oxygen.
- Intentional CO poisoning
- Unable to obtain informed consent
- Moribund patient
Show all 18Show fewer
- Concomitant smoke inhalation with cyanide poisoning
- Bleomycin use within two weeks of study enrollment
- Intracardiac defibrillator that cannot be deactivated
- Non-English speaking
- Unlikely to return at 6 weeks
- History of central nervous system (CNS) disease (i.e., Alzheimer's, Parkinson's, dementia, demyelinating disease (MS), etc.)
- History of prior brain injury (i.e., stroke, traumatic brain injury)
- Presence of chronic debilitating disease likely to result in death within 12 months (i.e., kidney failure on dialysis, heart failure)
- Subject has a significant medical condition or conditions that would interfere with the treatment, safety, or compliance with the protocol.
- Intubated subjects
- Subjects requiring greater than 50% oxygen by non-rebreather facemask or exhibiting evidence of respiratory compromise or heart failure
- Subjects who, in the opinion of the investigator, are unable to comply with the requirements of the study or are unsuitable for any reason. The investigator and the Sponsor, prior to enrolling the subject on a case-by-case basis, must approve and document any waiver of these inclusion and exclusion criteria.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Intermountain LDS Hospital
Salt Lake City, Utah, 84143
Intermountain Medical Center
Salt Lake City, Utah, 84157-7000
About this study
Official title: Randomized Trial of One Versus Three Hyperbaric Oxygen Treatments for Acute CO Poisoning
This randomized trial will investigate important clinical outcomes of patients with acute carbon monoxide poisoning randomized to receive either one or three hyperbaric oxygen treatments.
Read the detailed description
All patients presenting with acute carbon monoxide poisoning will receive one hyperbaric oxygen treatment (barring contraindications for hyperbaric oxygen therapy). After this treatment, eligible patients who provide consent will be randomly allocated to receive two sham sessions, or two additional hyperbaric oxygen sessions administered in a double-blind fashion.
Outcome measures will be administered at 6 weeks and 6 months.
- Conditions
- Carbon Monoxide Poisoning
- Being tested
- Hyperbaric Oxygen (HBO2) - 3 sessions, Hyperbaric Oxygen (HBO2) - 1 session
- Keywords
- Carbon monoxide poisoning, Hyperbaric oxygen therapy, Randomized controlled trial, Clinical investigation
- Medical subject headings
- Carbon Monoxide Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Oxygen (HBO2) - 3 sessionsCombination product
Also called Hyperbaric Oxygen, HBO2, HBO, HBOT
Before patients are offered an opportunity to participate in this study, they will receive a single hyperbaric oxygen session. During the first session, hyperbaric oxygen will be administered at 3.0 atmospheres absolute (atm abs) for 25 minutes breathing oxygen, 5 minutes air breathing, 25 minutes oxygen breathing, 5 minutes air breathing, pressure reduced to 2.0 atm abs for 30 minutes breathing oxygen, 5 minutes air breathing, and 30 minutes oxygen breathing.
For the second and third hyperbaric oxygen sessions, the subject will breathe 100% oxygen delivered at 2 atm abs for 90 minutes with two 5-minute air breathing periods.
Hyperbaric Oxygen (HBO2) - 1 sessionCombination product
Also called HBO2
During the first session, hyperbaric oxygen will be administered at 3.0 atmospheres absolute (atm abs) for 25 minutes breathing oxygen, 5 minutes air breathing, 25 minutes oxygen breathing, 5 minutes air breathing, pressure reduced to 2.0 atm abs for 30 minutes breathing oxygen, 5 minutes air breathing, and 30 minutes oxygen breathing.
The second and third chamber sessions are sham sessions: room air delivered at 1.0 atmospheres absolute for 90 minutes with two sham 5-minute air breathing periods.
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric Oxygen (HBO2) - 3 sessions | Active comparator | Subjects undergo 3 hyperbaric oxygen sessions within 24 hours following carbon monoxide poisoning. Receives: Combination Product: Hyperbaric Oxygen (HBO2) - 3 sessions |
| Hyperbaric Oxygen (HBO2) - 1 session | Sham comparator | Subjects undergo 1 hyperbaric oxygen session and then 2 sham chamber sessions within 24 hours of carbon monoxide poisoning. Receives: Combination Product: Hyperbaric Oxygen (HBO2) - 1 session |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-week cognitive sequelae
Presence of cognitive sequelae at 6-week follow-up
Measured: 6 weeks after poisoning
Secondary outcomes (4)
Neurological examination
Presence of neurological abnormalities
Measured: 6 weeks and 6 months after poisoning
Depression, anxiety or post-traumatic stress syndrome
Presence of depression, anxiety, or PTSD symptoms
Measured: 6 weeks and 6 months after poisoning
Vocational assessment
Results of vocational testing
Measured: 6 weeks and 6 months after poisoning
Patient self-reports of CO-related problems
Participant-reported outcome
Measured: 6 weeks and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2007 (estimated)
- Study start3 Jun 2007
- Primary completion10 Sep 2016
- Study completion28 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Deseret Foundation
- Responsible party
- Sponsor
- Investigators
- Lindell K Weaver, MD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00465855
- Sponsor's protocol ID
- 1002700
- Acronym
- 1V3CORCT
- Status last verified
- Feb 2021
- First submitted
- 23 Apr 2007
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Publications
Weaver LK, Hopkins RO, Chan KJ, Churchill S, Elliott CG, Clemmer TP, Orme JF Jr, Thomas FO, Morris AH. Hyperbaric oxygen for acute carbon monoxide poisoning. N Engl J Med. 2002 Oct 3;347(14):1057-67. doi: 10.1056/NEJMoa013121.
PubMed 12362006
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of One Versus Three Hyperbaric Oxygen Treatments for Acute CO Poisoning
- ClinicalTrials.gov ID
- NCT00465855
- Acronym / sponsor ID
- 1V3CORCT / 1002700
- Conditions
- Carbon Monoxide Poisoning
- Keywords
- Carbon monoxide poisoning, Hyperbaric oxygen therapy, Randomized controlled trial, Clinical investigation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Collaborators
- Deseret Foundation
- Study start
- 3 Jun 2007 (actual)
- Primary completion
- 10 Sep 2016 (actual)
- Study completion
- 28 Jan 2017 (actual)
- First posted
- 25 Apr 2007 (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.
This randomized trial will investigate important clinical outcomes of patients with acute carbon monoxide poisoning randomized to receive either one or three hyperbaric oxygen treatments.
Detailed description
All patients presenting with acute carbon monoxide poisoning will receive one hyperbaric oxygen treatment (barring contraindications for hyperbaric oxygen therapy). After this treatment, eligible patients who provide consent will be randomly allocated to receive two sham sessions, or two additional hyperbaric oxygen sessions administered in a double-blind fashion.
Outcome measures will be administered at 6 weeks and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric Oxygen (HBO2) - 3 sessions | Active comparator | Combination Product: Hyperbaric Oxygen (HBO2) - 3 sessionsSubjects undergo 3 hyperbaric oxygen sessions within 24 hours following carbon monoxide poisoning. |
| Hyperbaric Oxygen (HBO2) - 1 session | Sham comparator | Combination Product: Hyperbaric Oxygen (HBO2) - 1 sessionSubjects undergo 1 hyperbaric oxygen session and then 2 sham chamber sessions within 24 hours of carbon monoxide poisoning. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Symptomatic CO poisoning (headache, nausea, vomiting, dizziness, fatigue, muscle aches, slowed mentation, confusion, or loss of consciousness).
- Carboxyhemoglobin (COHb) levels > 10% or confirmation of poisoning with ambient levels > 50 ppm in a patient with symptoms compatible with CO poisoning and no other reasonable explanation for their signs and symptoms.
- Less than 24 hours from removal from the source of CO exposure and study enrollment.
- Accidental poisoning
Key exclusion criteria (18 listed)
- Pregnancy
- Age < 18 years or > 79 years
- Complication during first hyperbaric oxygen session precluding subsequent hyperbaric oxygen.
- Intentional CO poisoning
- Unable to obtain informed consent
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 |
|---|---|---|
| Hyperbaric Oxygen (HBO2) - 3 sessionsAlso: Hyperbaric Oxygen, HBO2, HBO, HBOTBefore patients are offered an opportunity to participate in this study, they will receive a single hyperbaric oxygen session. During the first session, hyperbaric oxygen will be administered at 3.0 atmospheres absolute (atm abs) for 25 minutes breathing oxygen, 5 minutes air breathing, 25 minutes oxygen breathing, 5 minutes air breathing, pressure reduced to 2.0 atm abs for 30 minutes breathing oxygen, 5 minutes air breathing, and 30 minutes oxygen breathing. For the second and third hyperbaric oxygen sessions, the subject will breathe 100% oxygen delivered at 2 atm abs for 90 minutes with two 5-minute air breathing periods. | Combination product | Hyperbaric Oxygen (HBO2) - 3 sessions |
| Hyperbaric Oxygen (HBO2) - 1 sessionAlso: HBO2During the first session, hyperbaric oxygen will be administered at 3.0 atmospheres absolute (atm abs) for 25 minutes breathing oxygen, 5 minutes air breathing, 25 minutes oxygen breathing, 5 minutes air breathing, pressure reduced to 2.0 atm abs for 30 minutes breathing oxygen, 5 minutes air breathing, and 30 minutes oxygen breathing. The second and third chamber sessions are sham sessions: room air delivered at 1.0 atmospheres absolute for 90 minutes with two sham 5-minute air breathing periods. | Combination product | Hyperbaric Oxygen (HBO2) - 1 session |
Primary outcome
6-week cognitive sequelae
Time frame: 6 weeks after poisoning
Presence of cognitive sequelae at 6-week follow-up
4 secondary outcomes
Neurological examination
Time frame: 6 weeks and 6 months after poisoning
Depression, anxiety or post-traumatic stress syndrome
Time frame: 6 weeks and 6 months after poisoning
Vocational assessment
Time frame: 6 weeks and 6 months after poisoning
Patient self-reports of CO-related problems
Time frame: 6 weeks and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
- Background: PubMed 12362006Weaver LK, Hopkins RO, Chan KJ, Churchill S, Elliott CG, Clemmer TP, Orme JF Jr, Thomas FO, Morris AH. Hyperbaric oxygen for acute carbon monoxide poisoning. N Engl J Med. 2002 Oct 3;347(14):1057-67. doi: 10.1056/NEJMoa013121.
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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.
Lindell K Weaver, MD principal investigator
Intermountain Health Care, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hyperbaric Oxygen (HBO2) - 3 sessions and Hyperbaric Oxygen (HBO2) - 1 session in people with Carbon Monoxide Poisoning, run by Intermountain Health Care, Inc. at 2 sites 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 4 inclusion and 18 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: finished, as of the sponsor's last update on 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-week cognitive sequelae (time frame: 6 weeks after poisoning). 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 NCT00465855, which also lists 1 linked publication.
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 12 Feb 2021.