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

Phase 3TerminatedNCT01100515

University of Versailles179 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 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

179

Conditions

Carbon Monoxide Poisoning

Interventions

normobaric oxygen therapyOTHER

oxygen therapy was delivered via a full face mask at high flow to achieve 100% of inspired oxygen fraction

Hyperbaric oxygen therapyOTHER

Hyperbaric oxygen therapy was delivered in a hyperbaric chamber, pressurized at 2 absolute atmosphere (1 hour plateau) and the patient breathed high oxygen concentration via a full face mask followed by 4 hours of normobaric oxygen therapy

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. * 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.

Locations (1)

Raymond Poincaré Hospital

Garches, France

Outcomes

Primary Outcomes

full recovery

Full 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

variations in carboxyhemoglobin levels

the difference in serum carboxyhemoglobin levels between baseline values and values recorded immeadiately after study treatment completion

Time frame: at 12 hours from randomization

serious adverse events

any complications of hyperbaric oxygen therapy

Time frame: at one month

Data from ClinicalTrials.gov

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