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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
75
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.
Intermountain LDS Hospital
Salt Lake City, Utah, United States
Intermountain Medical Center
Salt Lake City, Utah, United States
6-week cognitive sequelae
Presence of cognitive sequelae at 6-week follow-up
Time frame: 6 weeks after poisoning
Neurological examination
Presence of neurological abnormalities
Time frame: 6 weeks and 6 months after poisoning
Depression, anxiety or post-traumatic stress syndrome
Presence of depression, anxiety, or PTSD symptoms
Time frame: 6 weeks and 6 months after poisoning
Vocational assessment
Results of vocational testing
Time frame: 6 weeks and 6 months after poisoning
Patient self-reports of CO-related problems
Participant-reported outcome
Time frame: 6 weeks and 6 months
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