Hyperbaric Oxygen Therapy for Comatose Patients With Acute Carbon Monoxide Poisoning

Phase 3

Terminated

• Conditions: Carbon Monoxide Poisoning

• Registration Number: NCT01099995
• Lead Sponsor: University of Versailles

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Primary Completion: 2000-01
• Study Completion: 2000-02
• Status Verified: 2010-04
• Study First Submitted: 2010-04-05
• Study First Submitted QC: 2010-04-07
• Last Update Submitted: 2010-04-07
• Study First Posted: 2010-04-08
• Last Update Posted: 2010-04-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
complete recovery	at one month	Complete recovery was defined as an absence of symptoms reported on the self-assessment questionnaire with a normal physical exam (including normal neuropsychological functions).

Secondary Outcome Measures

Name	Time	Method
persistent neurological sequels	at one month	Neurological sequels were considered persistent (PNS) if they were present both at hospital discharge and at one-month evaluation, regardless of the type of manifestation.
delayed neurological sequels	at one month	Delayed neurological sequelae (DNS) were any neurological manifestations that appeared between hospital discharge and one-month evaluation, regardless of their severity. Patients with DNS were those considered fully recovered at hospital discharge but with neurological manifestations at one-month evaluation.
the difference in carboxyhemoglobin levels before/after treatment completion	at 12 hours from randomization	the difference between serum levels of carboxyhemoglobin at baseline and those recorded immedaitely after study treatment completion
serious adverse events	at one month	any complication of hyperbaric oxygen therapy

Trial Locations

Locations (1)

Raymond Poincaré Hospital; 🇫🇷 GArches, France