Carbon Monoxide Poisoning Clinical Trial
— 1V3CORCTOfficial title:
Randomized Trial of One Versus Three Hyperbaric Oxygen Treatments for Acute CO Poisoning
Verified date | February 2021 |
Source | Intermountain Health Care, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 75 |
Est. completion date | January 28, 2017 |
Est. primary completion date | September 10, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 79 Years |
Eligibility | 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% 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. |
Country | Name | City | State |
---|---|---|---|
United States | Intermountain LDS Hospital | Salt Lake City | Utah |
United States | Intermountain Medical Center | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
Intermountain Health Care, Inc. | Deseret Foundation |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 6-week cognitive sequelae | Presence of cognitive sequelae at 6-week follow-up | 6 weeks after poisoning | |
Secondary | Neurological examination | Presence of neurological abnormalities | 6 weeks and 6 months after poisoning | |
Secondary | Depression, anxiety or post-traumatic stress syndrome | Presence of depression, anxiety, or PTSD symptoms | 6 weeks and 6 months after poisoning | |
Secondary | Vocational assessment | Results of vocational testing | 6 weeks and 6 months after poisoning | |
Secondary | Patient self-reports of CO-related problems | Participant-reported outcome | 6 weeks and 6 months |
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