Clinical Trial: One vs. Three Hyperbaric Oxygen Treatments for Acute Carbon Monoxide Poisoning
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Randomized Trial of One Versus Three Hyperbaric Oxygen Treatments for Acute CO Poisoning
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 Summary:
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.
Sponsor: Intermountain Health Care, Inc.
Current Primary Outcome: 6-week cognitive sequelae [ Time Frame: 6 weeks after poisoning ]
Original Primary Outcome: 6-week cognitive sequelae
Current Secondary Outcome:
- Neurological examination [ Time Frame: 6 weeks and 6 months after poisoning ]
- Depression, anxiety or post-traumatic stress syndrome [ Time Frame: 6 weeks and 6 months after poisoning ]
- Vocational assessment [ Time Frame: 6 weeks and 6 months after poisoning ]
- Patient self-reports of CO-related problems [ Time Frame: 6 weeks and 6 months ]
Original Secondary Outcome:
- Neurological examination
- Depression, anxiety or post-traumatic stress syndrome
- Vocational assessment
- Patient self-reports of CO-related problems
- We will follow patients at 6 months to categorize long-term outcomes, but the prime outcome follow-up period is 6 weeks after CO poisoning.
Information By: Intermountain Health Care, Inc.
Dates:
Date Received: April 23, 2007
Date Started: April 2007
Date Completion: May 2018
Last Updated: October 4, 2016
Last Verified: October 2016
