One vs. Three Hyperbaric Oxygen Treatments for Acute Carbon Monoxide Poisoning
Completed · Phase 4 · Has a placebo group
Conditions studied: Carbon Monoxide Poisoning
In brief
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.
Key facts
- Study ID
- NCT00465855
- Run by
- Intermountain Health Care, Inc.
- People needed
- 75
- Starts
- 2007-06-03
- Expected to finish
- 2017-01-28
- Last updated by the study team
- 2021-02-12
Who can join
Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.
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.
- 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.
Where it is running
- Intermountain LDS Hospital — Salt Lake City, Utah, United States
- Intermountain Medical Center — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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