Optimal Number of Hyperbaric Oxygen Treatments for Carbon Monoxide Poisoning

University of Alberta

Status: Enrolling

Conditions: Carbon Monoxide Poisoning; Hyperbaric Oxygen Therapy

Treatments: Procedure: Hyperbaric Oxygen Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06619717

Pro00146529

Details and patient eligibility

About

The optimal treatment strategy with hyperbaric oxygen therapy has been the subject of some debate over the past 3 decades. Initial landmark studies showed a decrease in the incidence of DNS with a single treatment and also with three treatments over the course of 24 hours. These two strategies have continued to be used widely without further evidence comparing them in a direct fashion. Retrospective publications in the years since have been largely conflicting about the benefit of additional hyperbaric treatments. The investigators would seek to randomize patients with carbon monoxide poisoning to receive with 1 or 3 treatments with hyperbaric oxygen and measure their neurologic outcomes.

Full description

HBO is a niche treatment modality, especially in Canada. There are few sites which offer this care, and as such, treatment often carries significant logistical challenges. Since 2021, the HBO unit at the Misericordia hospital has averaged 49 patients per year being treated for CO poisoning. This HBO unit provides coverage to patients within Alberta, Saskatchewan, Manitoba, Yukon, and Northwest Territories. Due to the significant barriers to treatment, including the high cost to the public system, it is important to clearly understand how to best treat these patients.

Purpose:

The aim of this study is to assess whether a single treatment session of hyperbaric oxygen is non-inferior to three treatments for patients with acute carbon monoxide poisoning.

Enrollment: 300 estimated patients

Sex: All

Ages: 17+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All adult (over 17 years old) patients referred to a Hyperbaric Unit for acute carbon monoxide poisoning.

Exclusion criteria

• Obtunded
• Mechanically ventilated
• Pregnant
• Incarcerated
• Cognitively impaired (acutely or chronically)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Single HBO treatment

Active Comparator group

Description:

The exact parameters of each dive will be left to individual clinicians. Commonly used treatments would be: 1 treatment: 100% oxygen at 2.8 atmospheres for 30 minutes followed by a 10-minute air break, then 100% oxygen at 2 atmospheres for 60 minutes with one 10-minute air break after 30 minutes

Treatment:

Procedure: Hyperbaric Oxygen Therapy

Procedure: Hyperbaric Oxygen Therapy

Three HBO treatments

Experimental group

Description:

The exact parameters of each dive will be left to individual clinicians. Commonly used treatments would be: 3 treatments: Weaver protocol or similar variation (i.e. 100% oxygen at 3 atmospheres for 90 minutes with two 10-minute air breaks every 30 minutes. This will be repeated every 8 hours until 3 treatments are complete.)

Treatment:

Procedure: Hyperbaric Oxygen Therapy

Procedure: Hyperbaric Oxygen Therapy