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

Phase 3

Terminated

• Conditions: Carbon Monoxide Poisoning
• Interventions: Other: Hyperbaric oxygen therapy; Other: normobaric oxygen therapy

• Registration Number: NCT01100515
• 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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 1989-10
• Primary Completion: 2000-01
• Study Completion: 2000-02
• Status Verified: 2010-04
• Study First Submitted: 2010-04-05
• Study First Submitted QC: 2010-04-08
• Last Update Submitted: 2010-04-08
• Study First Posted: 2010-04-09
• Last Update Posted: 2010-04-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 179

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
full recovery	at one month	Full 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
variations in carboxyhemoglobin levels	at 12 hours from randomization	the difference in serum carboxyhemoglobin levels between baseline values and values recorded immeadiately after study treatment completion
serious adverse events	at one month	any complications of hyperbaric oxygen therapy
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

Trial Locations

Locations (1)

Raymond Poincaré Hospital; 🇫🇷 Garches, France