One vs. Three Hyperbaric Oxygen Treatments for Acute Carbon Monoxide Poisoning
1V3CORCT
Randomized Trial of One Versus Three Hyperbaric Oxygen Treatments for Acute CO Poisoning
1 other identifier
interventional
75
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2007
Longer than P75 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2007
CompletedFirst Posted
Study publicly available on registry
April 25, 2007
CompletedStudy Start
First participant enrolled
June 3, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 10, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 28, 2017
CompletedFebruary 12, 2021
February 1, 2021
9.3 years
April 23, 2007
February 11, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
6-week cognitive sequelae
Presence of cognitive sequelae at 6-week follow-up
6 weeks after poisoning
Secondary Outcomes (4)
Neurological examination
6 weeks and 6 months after poisoning
Depression, anxiety or post-traumatic stress syndrome
6 weeks and 6 months after poisoning
Vocational assessment
6 weeks and 6 months after poisoning
Patient self-reports of CO-related problems
6 weeks and 6 months
Study Arms (2)
Hyperbaric Oxygen (HBO2) - 3 sessions
ACTIVE COMPARATORSubjects undergo 3 hyperbaric oxygen sessions within 24 hours following carbon monoxide poisoning.
Hyperbaric Oxygen (HBO2) - 1 session
SHAM COMPARATORSubjects undergo 1 hyperbaric oxygen session and then 2 sham chamber sessions within 24 hours of carbon monoxide poisoning.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Intermountain Health Care, Inc.lead
- Deseret Foundationcollaborator
Study Sites (2)
Intermountain LDS Hospital
Salt Lake City, Utah, 84143, United States
Intermountain Medical Center
Salt Lake City, Utah, 84157-7000, United States
Related Publications (1)
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.
PMID: 12362006BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lindell K Weaver, MD
Intermountain Health Care, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2007
First Posted
April 25, 2007
Study Start
June 3, 2007
Primary Completion
September 10, 2016
Study Completion
January 28, 2017
Last Updated
February 12, 2021
Record last verified: 2021-02