Carbon Monoxide Hyperbaric Oxygen With Steroid Therapy

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
University of Nebraska
Study ID
NCT06574048
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Carbon Monoxide Encephalopathy
  • Carbon Monoxide Intoxication
  • Carbon Monoxide Poisoning
  • Carbon Monoxide-induced Parkinsonism

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • saline placebo — DRUG
    IV saline bolus
  • Dexamethasone — DRUG
    10mg IV Dexamethasone

Study Details

Hyperbaric Oxygen Therapy (HBO) is routine treatment of carbon monoxide (CO) poisoning to prevent delayed neurological sequelae. This study looking to see if neurologic outcomes are improved with the addition of dexamethasone. CO poisoning can initiate a free radical mediated process that can instigate a demyelinating process resulting in long term neurological sequelae in some, but not all patients. In other demyelinating disorders, steroids are a part of first line treatment. HBO is already used for acute CO poisoning, so this pilot study will try to ascertain if the addition of steroids in concert with each hyperbaric oxygen session will yield improved outcomes.

Key Dates

Start date
Jul 31, 2026
Status verified
Oct 2025
Primary completion
Jul 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Hyperbaric Oxygen Therapy with Dexamethasone
    Participants will be treated with hyperbaric oxygen (HBO) therapy within three days of acute carbon monoxide poisoning. Treatment is a minimum of three inpatient sessions. Participants will also receive 10 mg dexamethasone per day while receiving HBO therapy (minimum of two doses, maximum of five doses if participants' stay is longer than three days). After three treatment sessions, participants will discharge home, barring no other medical complications requiring further hospitalization. In addition, continued HBO therapy plus steroids will be offered if participants are still dealing with CO poisoning sequelae as determined by study outcome measures.
  • Placebo Comparator: Hyperbaric Oxygen Therapy with Placebo (Saline)
    Participants will be treated with hyperbaric oxygen (HBO) therapy within three days of acute carbon monoxide poisoning. Treatment is a minimum of three inpatient sessions. Participants will also a saline placebo instead of dexamethasone while receiving HBO therapy. After three treatment sessions, participants will discharge home, barring no other medical complications requiring further hospitalization. In addition, continued HBO therapy plus steroids will be offered if participants are still dealing with CO poisoning sequelae as determined by study outcome measures.

Primary Outcome Measure

Montreal Cognitive Assessment (MoCA) [ Time Frame: Prior to hospital discharge after HBO therapy is no longer clinically warranted, and post-discharge at 2 weeks, 6 weeks, and 12 weeks. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Nebraska Medicine, Hyperbaric Medicine Program, Clarkson TowerOmahaNebraska68105
Jeffrey S Cooper, MD
[email protected]
402-552-2490

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By research site
Nebraska Medicine, Hyperbaric Medicine Program, Clarkson Tower· Omaha, NE

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