Carbon Monoxide Poisoning
Conditions
Keywords
Carbon monoxide poisoning, Hyperbaric oxygen therapy, Randomized controlled trial, Clinical investigation
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.
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.
Interventions
COMBINATION_PRODUCTHyperbaric Oxygen (HBO2) - 3 sessions
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.
COMBINATION_PRODUCTHyperbaric Oxygen (HBO2) - 1 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. 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.
Sponsors
Deseret Foundation
Intermountain Health Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-week cognitive sequelae | 6 weeks after poisoning | Presence of cognitive sequelae at 6-week follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neurological examination | 6 weeks and 6 months after poisoning | Presence of neurological abnormalities |
| Depression, anxiety or post-traumatic stress syndrome | 6 weeks and 6 months after poisoning | Presence of depression, anxiety, or PTSD symptoms |
| Vocational assessment | 6 weeks and 6 months after poisoning | Results of vocational testing |
| Patient self-reports of CO-related problems | 6 weeks and 6 months | Participant-reported outcome |
Countries
United States
Outcome results
None listed