One vs. Three Hyperbaric Oxygen Treatments for Acute Carbon Monoxide Poisoning (NCT00465855) | Clinical Trial Compass
CompletedPhase 4
One vs. Three Hyperbaric Oxygen Treatments for Acute Carbon Monoxide Poisoning
United States75 participantsStarted 2007-06-03
Plain-language 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.
Who can participate
Age range18 Years – 79 Years
SexALL
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Inclusion Criteria:
* 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
Exclusion Criteria:
* 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% oxyg…