Hyperbaric Oxygen Therapy for Acute Domestic Carbon Monoxide (CO) Poisoning

University of Versailles

Status and phase: Terminated; Phase 3

Conditions: Carbon Monoxide Poisoning

Treatments: Other: normobaric oxygen therapy; Other: Hyperbaric oxygen therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01100515

CO89

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 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.

Enrollment: 179 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.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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179 participants in 2 patient groups

Experimental arm

Experimental group

Description:

Hyperbaric oxygen therapy at 2 absolute atmosphere (1-hour plateau) followed by 4 hours of normobaric oxygen therapy

Treatment:

Other: Hyperbaric oxygen therapy

Control

Active Comparator group

Description:

6 hours course of normobaric oxygen therapy via a face full mask

Treatment:

Other: normobaric oxygen therapy