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

Study Overview
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Brief Summary
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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.

Official Title
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Phase 3 Study of Hyperbaric Oxygen Therapy in Non-Comatose Patients With Acute Domestic Carbon Monoxide Poisoning

Conditions
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Carbon Monoxide Poisoning

Intervention / Treatment
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* Other: normobaric oxygen therapy
* Other: Hyperbaric oxygen therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental arm<br>Hyperbaric oxygen therapy at 2 absolute atmosphere (1-hour plateau) followed by 4 hours of normobaric oxygen therapy | Other: Hyperbaric oxygen therapy<br>* 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<br>|
| Active Comparator: Control<br>6 hours course of normobaric oxygen therapy via a face full mask | Other: normobaric oxygen therapy<br>* oxygen therapy was delivered via a full face mask at high flow to achieve 100% of inspired oxygen fraction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | at one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | at one month | 
| variations in carboxyhemoglobin levels | the difference in serum carboxyhemoglobin levels between baseline values and values recorded immeadiately after study treatment completion | at 12 hours from randomization | 
| serious adverse events | any complications of hyperbaric oxygen therapy | at one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intoxication, carbon monoxide, adults, domestic accident, acute domestic carbon monoxide poisoning