Hyperbaric Oxygen Therapy for Comatose Patients With Acute Carbon Monoxide Poisoning

University of Versailles

Status and phase: Terminated; Phase 3

Conditions: Carbon Monoxide Poisoning

Treatments: Other: Hyperbaric oxygen therapy; Other: hyperbaric oxygen therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01099995

CO89-2

Details and patient eligibility

About

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 two sessions of HBO at 2 absolute atmosphere and one session of HBO at 2 absolute atmosphere followed by 4 hours of normobaric oxygen therapy in comatose adult victims of acute domestic carbon monoxide poisoning.

Enrollment: 170 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients older than 15 years of age
• admitted for domestic CO poisoning within 12 hours after the end of CO exposure
• initial coma, regardless of consciousness at hospital admission
• carboxyhemoglobin level at presentation greater than 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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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170 participants in 2 patient groups

One HBO session

Active Comparator group

Description:

hyperbaric oxygen therapy one dive at 2 absolute atmosphere (1-hour plateau) - oxygen was delivered via a full face mask - followed by 4 hours of normobaric oxygen therapy

Treatment:

Other: Hyperbaric oxygen therapy

2 HBO sessions

Experimental group

Description:

Two sessions of hyperbaric oxygen therapy at 2 absolute atmosphere (1-hour plateau) with oxygen delivered via a full face mask at 100% inspired oxygen fraction or via mechanical ventilation

Treatment:

Other: hyperbaric oxygen therapy