Hyperbaric Oxygen Therapy for Comatose Patients With Acute Carbon Monoxide Poisoning

Phase 3TerminatedNCT01099995

University of Versailles170 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

170

Conditions

Carbon Monoxide Poisoning

Interventions

Hyperbaric oxygen therapyOTHER

one dive at 2 absolute atmosphere (1-hour plateau) with 30 min time for compression and decompression - oxygen was delivered via a full face mask at high concentration to achieve a 100% inspired fraction of oxygen or via mechanical ventilation

hyperbaric oxygen therapyOTHER

two dives at 2 absolute atmosphere (1-hour plateau) with 30 min of compression and 30 min of decompression - oxygen being delivered via a full face mask at 100% inspired oxygen fraction or via mechanical ventilation

Eligibility

Sex: ALLMin age: 15 Years

Medical Language ↔ Plain English

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

Locations (1)

Raymond Poincaré Hospital

Garches, France

Outcomes

Primary Outcomes

complete recovery

Complete recovery was defined as an absence of symptoms reported on the self-assessment questionnaire with a normal physical exam (including normal neuropsychological functions).

Time frame: at one month

Secondary Outcomes

persistent neurological sequels

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.

Time frame: at one month

delayed neurological sequels

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.

Time frame: at one month

the difference in carboxyhemoglobin levels before/after treatment completion

the difference between serum levels of carboxyhemoglobin at baseline and those recorded immedaitely after study treatment completion

Time frame: at 12 hours from randomization

serious adverse events

any complication of hyperbaric oxygen therapy

Time frame: at one month

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.