Optimal Number of Hyperbaric Oxygen Treatments for Carbon Monoxide Poisoning

NCT ID: NCT06619717

Last Updated: 2025-01-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-24
• Study Completion Date: 2028-06-01

Brief Summary

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.

Detailed 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.

Conditions

Hyperbaric Oxygen Therapy; Carbon Monoxide Poisoning

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single HBO treatment

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

Group Type: ACTIVE_COMPARATOR

Hyperbaric Oxygen Therapy

Intervention Type: PROCEDURE

Single treatment with hyperbaric oxygen. Exact parameters left to treating physician but commonly: 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

Three HBO treatments

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.)

Group Type: EXPERIMENTAL

Hyperbaric Oxygen Therapy

Intervention Type: PROCEDURE

Three treatments with hyperbaric oxygen therapy. The exact parameters of each dive will be left to individual clinicians. Commonly used treatments would be:

Weaver protocol, or similar (i.e. 100% oxygen at 3 atmospheres for 90 minutes with two 10-minute air breaks every 30 minutes. Repeat this every 8 hours until 3 treatments are complete.)

Interventions

Hyperbaric Oxygen Therapy

Three treatments with hyperbaric oxygen therapy. The exact parameters of each dive will be left to individual clinicians. Commonly used treatments would be:

Weaver protocol, or similar (i.e. 100% oxygen at 3 atmospheres for 90 minutes with two 10-minute air breaks every 30 minutes. Repeat this every 8 hours until 3 treatments are complete.)

Intervention Type: PROCEDURE

Hyperbaric Oxygen Therapy

Single treatment with hyperbaric oxygen. Exact parameters left to treating physician but commonly: 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

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Minimum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian Rowe, MD, MSc, CCFP (EM), FCCP

Role: STUDY_DIRECTOR

Professor in the Department of Emergency Medicine, Faculty of Medicine & Dentistry, College of Health Sciences, at the University of Alberta

Locations

University of Alberta

Edmonton, Alberta, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Jesse Hill

Role: CONTACT

jlh1@ualberta.ca

780-735-2627

Facility Contacts

Jesse Hill

Role: primary

jlh1@ualberta.ca

780-735-2627

Other Identifiers

Pro00146529

Identifier Type: -

Identifier Source: org_study_id