Clinical Trials Directory

Trials / Terminated

TerminatedNCT06619717

Optimal Number of Hyperbaric Oxygen Treatments for Carbon Monoxide Poisoning

Optimizing Hyperbaric Oxygen Treatments for Acute Carbon Monoxide Poisoning: An Open-label Randomized Study.

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
2 (actual)
Sponsor
University of Alberta · Academic / Other
Sex
All
Age
17 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDUREHyperbaric Oxygen TherapyThree 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.)
PROCEDUREHyperbaric Oxygen TherapySingle 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

Timeline

Start date
2025-01-24
Primary completion
2026-02-10
Completion
2026-02-10
First posted
2024-10-01
Last updated
2026-03-13

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT06619717. Inclusion in this directory is not an endorsement.