Hyperbaric Oxygen Therapy for Carbon Monoxide Poisoning

Overseen By Jesse Hill

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Obtunded, Mechanically ventilated, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 24 hours

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is hyperbaric oxygen therapy safe for humans?

Hyperbaric oxygen therapy (HBOT) has been widely used and studied for treating carbon monoxide poisoning, and there is a lot of research supporting its use. While the studies focus on its effectiveness, the widespread use and research suggest it is generally considered safe for humans when used appropriately. ^{1 2 3 4 5}

How does hyperbaric oxygen therapy differ from other treatments for carbon monoxide poisoning?

Hyperbaric oxygen therapy is unique because it involves breathing 100% oxygen at pressures higher than normal atmospheric pressure, which helps quickly remove carbon monoxide from the blood and reoxygenate tissues more effectively than standard oxygen therapy. ^{2 6 7 8 9}

What data supports the effectiveness of the treatment Hyperbaric Oxygen Therapy for Carbon Monoxide Poisoning?

Hyperbaric oxygen therapy (HBO) helps quickly increase oxygen levels in the body and remove carbon monoxide, which can be crucial for patients who have been unconscious due to poisoning. Some case reports show that patients treated with HBO had no long-term brain damage after recovery, suggesting it may help prevent serious complications. ^{1 3 6 8 9}

Who Is on the Research Team?

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

Principal Investigator

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

Are You a Good Fit for This Trial?

Adults over 17 years old who have been referred to a Hyperbaric Unit for acute carbon monoxide poisoning are eligible for this trial. Specific details about who cannot participate were not provided.

Inclusion Criteria

I am over 17 and have been referred for treatment due to carbon monoxide poisoning.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either 1 or 3 hyperbaric oxygen treatments for carbon monoxide poisoning

24 hours

1-3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on delayed neurologic sequelae

6 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Hyperbaric Oxygen Therapy

Trial Overview The trial is testing whether one or three hyperbaric oxygen treatments are more effective in treating carbon monoxide poisoning. Patients will be randomly assigned to receive either one treatment or three treatments, and their neurological outcomes will be compared.

How Is the Trial Designed?

Group I: Three HBO treatments Experimental Treatment 1 Intervention

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 II: Single HBO treatment Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Published Research Related to This Trial

Hyperbaric oxygen (HBO) therapy is recommended for all carbon monoxide (CO) poisoning victims who are unconscious upon arrival at the emergency ward, as it facilitates rapid reoxygenation of tissues and accelerates CO elimination.

Despite existing literature on CO poisoning treatment, there is a significant need for more clinically controlled studies to better understand the efficacy and safety of HBO therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of carbon monoxide poisoning. Background and guidelines for oxygen therapy]. Ahrenkiel, JL., Jessen, B.[2017]

Patients with carbon monoxide poisoning need thorough assessment and education before receiving hyperbaric oxygen therapy to ensure safety and effectiveness.

Monitoring physiological changes after hyperbaric oxygen treatment is crucial for evaluating the patient's response and recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carbon monoxide poisoning: hyperbaric oxygenation preparations. Scherb, BJ.[2019]

A patient with severe carbon monoxide poisoning (CO-Hb concentration of 82%) was successfully treated with hyperbaric oxygen (HBO) therapy, despite experiencing cardiac arrest during decompression due to complications like acidosis and elevated potassium levels.

After completing HBO therapy, the patient showed no neurological issues three months post-treatment, indicating the efficacy of HBO therapy in preventing delayed neurological sequelae in severe CO poisoning cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Hyperbaric oxygen for carbon monoxide poisoning: case report of severe poisoning due to exhaust fumes]. Erdmann, M., Schöppenthau, H., Büttner, J.[2021]

Hyperbaric oxygen therapy (HBOT) did not significantly reduce in-hospital mortality in patients with carbon monoxide poisoning, with rates of 0.8% in the HBOT group compared to 1.2% in the control group.

However, patients receiving HBOT showed improved mental status and activities of daily living at discharge, indicating potential benefits for recovery, especially in those with non-severe poisoning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy and mortality from carbon monoxide poisoning: A nationwide observational study. Nakajima, M., Aso, S., Matsui, H., et al.[2020]

In a study of 172 patients with acute carbon monoxide poisoning, hyperbaric oxygen therapy resulted in a 100% total effective rate, with 93% of patients fully cured and 7% showing improvement.

Administering hyperbaric oxygen therapy within 6 hours of poisoning led to a 100% cure rate, significantly higher than the 78.9% cure rate for those treated after 6 hours, highlighting the importance of early intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical effect of hyperbaric oxygen therapy on groupment acute carbon monoxide poisoning]. Deng, DH., You, ZQ., Qi, B.[2013]

Approximately 1,500 patients with carbon monoxide poisoning are treated with hyperbaric oxygen therapy (HBO2) annually in the US, a number that has remained stable since 1992.

Only 23% of treatment facilities routinely administer more than one HBO2 session per patient, indicating variability in treatment protocols among facilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric treatment of patients with carbon monoxide poisoning in the United States. Hampson, NB., Little, CE.[2022]

Hyperbaric oxygen therapy (HBOT) is strongly supported by extensive research as an effective treatment for acute carbon monoxide poisoning, based on recent clinical studies and trials.

HBOT should be administered at a pressure of 2.5-3.0 atm absolute to optimize its therapeutic effects in treating carbon monoxide toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen should be used for carbon monoxide poisoning. Sethuraman, K., Thom, SR.[2023]

Hyperbaric oxygen therapy is effective in treating patients with carbon monoxide poisoning, as shown in a study of 34 patients who experienced various sources of poisoning, primarily from faulty heating systems.

Patients with poorer outcomes after treatment had higher serum CK levels, lower Glasgow coma scale scores, and longer delays in receiving first aid and hyperbaric therapy, highlighting the importance of timely intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of carbon monoxide poisoning with hyperbaric oxygen. Hsu, LH., Wang, JH.[2015]

Hyperbaric oxygen therapy (HBOT) significantly increases oxygen levels in the body and is effective for treating conditions like decompression illness and arterial air embolism, but its use for carbon monoxide poisoning in children is less well-established than in adults.

Due to their higher metabolic rates and developing nervous systems, infants and children may be more vulnerable to carbon monoxide poisoning, suggesting that special considerations are necessary when using HBOT in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy in childhood carbon monoxide poisoning. Liebelt, EL.[2019]

Citations

1. Denmark pubmed.ncbi.nlm.nih.gov

[Treatment of carbon monoxide poisoning. Background and guidelines for oxygen therapy]. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Carbon monoxide poisoning: hyperbaric oxygenation preparations. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

[Hyperbaric oxygen for carbon monoxide poisoning: case report of severe poisoning due to exhaust fumes]. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy and mortality from carbon monoxide poisoning: A nationwide observational study. [2020]

5. China pubmed.ncbi.nlm.nih.gov

[Clinical effect of hyperbaric oxygen therapy on groupment acute carbon monoxide poisoning]. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Hyperbaric treatment of patients with carbon monoxide poisoning in the United States. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen should be used for carbon monoxide poisoning. [2023]

8. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Treatment of carbon monoxide poisoning with hyperbaric oxygen. [2015]

9. United States pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy in childhood carbon monoxide poisoning. [2019]