Brief Summary

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Official Title: "Phase 3 Study of Hyperbaric Oxygen Therapy in Non-Comatose Patients With Acute Domestic Carbon Monoxide Poisoning"

Carbon monoxide poisoning still places a burden on the healthcare system worldwide. While oxygen therapy is the cornerstone treatment, the role and practical modalities of hyperbaric oxygen therapy (HBO) remain controversial. This study aimed at comparing one session of HBO at 2 absolute atmosphere followed by 4 hours of normobaric oxygen therapy to 6 hours of normobaric oxygen therapy in adult victims of acute domestic carbon monoxide poisoning and without coma.

• Study Type: Interventional
• Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
• Study Primary Completion Date: January 2000

Interventions Used in this Clinical Trial

• Other: normobaric oxygen therapy
  • oxygen therapy was delivered via a full face mask at high flow to achieve 100% of inspired oxygen fraction
• Other: Hyperbaric oxygen therapy
  • Hyperbaric oxygen therapy was delivered in a hyperbaric chamber, pressurized at 2 absolute atmosphere (1 hour plateau) and the patient breathed high oxygen concentration via a full face mask followed by 4 hours of normobaric oxygen therapy

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Experimental arm
  • Hyperbaric oxygen therapy at 2 absolute atmosphere (1-hour plateau) followed by 4 hours of normobaric oxygen therapy
• Active Comparator: Control
  • 6 hours course of normobaric oxygen therapy via a face full mask

Outcome Measures for this Clinical Trial

Primary Measures

• full recovery
  • Time Frame: at one month
    Safety Issue?: No

Secondary Measures

• persistent neurological sequels
  • Time Frame: at one month
    Safety Issue?: Yes
• delayed neurological sequels
  • Time Frame: at one month
    Safety Issue?: Yes
• variations in carboxyhemoglobin levels
  • Time Frame: at 12 hours from randomization
    Safety Issue?: No
• serious adverse events
  • Time Frame: at one month
    Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

Inclusion Criteria

• patients older than 15 years of age
• admitted for domestic CO poisoning within 12 hours after the end of CO exposure.
• had transient loss of consciousness (syncope, malaise)
• carboxyhemoglobin level at presentation >10% or 5%, in smokers and non-smokers, respectively.

Exclusion Criteria

• poisoning by more than one compound (e.g., CO plus a drug or CO plus other toxic gases such as those found in fire smoke
• suicide attempt
• pregnancy
• coma
• contraindications to HBO (circulatory collapse or pneumothorax)
• technical obstacles to HBO
• non domestic CO poisoning
• difficulty in determining whether the patient experienced initial loss of consciousness or initial coma
• consent refusal.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 15 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

• Lead Sponsor
  • University of Versailles
• Collaborator
  • Assistance Publique - Hôpitaux de Paris
• Provider of Information About this Clinical Study
  • Christophe Misse, DRRC Assistance Publique Hôpitaux de Paris