One vs. Three Hyperbaric Oxygen Treatments for Acute Carbon Monoxide Poisoning (1V3CORCT)

Randomized Trial of One Versus Three Hyperbaric Oxygen Treatments for Acute CO Poisoning

This randomized trial will investigate important clinical outcomes of patients with acute carbon monoxide poisoning randomized to receive either one or three hyperbaric oxygen treatments.

Study Overview

• Status: Completed
• Conditions: Carbon Monoxide Poisoning
• Intervention / Treatment: Combination product: Hyperbaric Oxygen (HBO2) - 3 sessions; Combination product: Hyperbaric Oxygen (HBO2) - 1 session

Detailed Description

All patients presenting with acute carbon monoxide poisoning will receive one hyperbaric oxygen treatment (barring contraindications for hyperbaric oxygen therapy). After this treatment, eligible patients who provide consent will be randomly allocated to receive two sham sessions, or two additional hyperbaric oxygen sessions administered in a double-blind fashion.

Outcome measures will be administered at 6 weeks and 6 months.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84143
      • Intermountain LDS Hospital
    • Salt Lake City, Utah, United States, 84157-7000
      • Intermountain Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Symptomatic CO poisoning (headache, nausea, vomiting, dizziness, fatigue, muscle aches, slowed mentation, confusion, or loss of consciousness).
• Carboxyhemoglobin (COHb) levels > 10% or confirmation of poisoning with ambient levels > 50 ppm in a patient with symptoms compatible with CO poisoning and no other reasonable explanation for their signs and symptoms.
• Less than 24 hours from removal from the source of CO exposure and study enrollment.
• Accidental poisoning

Exclusion Criteria:

• Pregnancy
• Age < 18 years or > 79 years
• Complication during first hyperbaric oxygen session precluding subsequent hyperbaric oxygen.
• Intentional CO poisoning
• Unable to obtain informed consent
• Moribund patient
• Concomitant smoke inhalation with cyanide poisoning
• Bleomycin use within two weeks of study enrollment
• Intracardiac defibrillator that cannot be deactivated
• Non-English speaking
• Unlikely to return at 6 weeks
• History of central nervous system (CNS) disease (i.e., Alzheimer's, Parkinson's, dementia, demyelinating disease (MS), etc.)
• History of prior brain injury (i.e., stroke, traumatic brain injury)
• Presence of chronic debilitating disease likely to result in death within 12 months (i.e., kidney failure on dialysis, heart failure)
• Subject has a significant medical condition or conditions that would interfere with the treatment, safety, or compliance with the protocol.
• Intubated subjects
• Subjects requiring greater than 50% oxygen by non-rebreather facemask or exhibiting evidence of respiratory compromise or heart failure
• Subjects who, in the opinion of the investigator, are unable to comply with the requirements of the study or are unsuitable for any reason. The investigator and the Sponsor, prior to enrolling the subject on a case-by-case basis, must approve and document any waiver of these inclusion and exclusion criteria.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hyperbaric Oxygen (HBO2) - 3 sessions; Subjects undergo 3 hyperbaric oxygen sessions within 24 hours following carbon monoxide poisoning.	Combination product: Hyperbaric Oxygen (HBO2) - 3 sessions; Before patients are offered an opportunity to participate in this study, they will receive a single hyperbaric oxygen session. During the first session, hyperbaric oxygen will be administered at 3.0 atmospheres absolute (atm abs) for 25 minutes breathing oxygen, 5 minutes air breathing, 25 minutes oxygen breathing, 5 minutes air breathing, pressure reduced to 2.0 atm abs for 30 minutes breathing oxygen, 5 minutes air breathing, and 30 minutes oxygen breathing. For the second and third hyperbaric oxygen sessions, the subject will breathe 100% oxygen delivered at 2 atm abs for 90 minutes with two 5-minute air breathing periods.; Other Names: HBOT; HBO; HBO2; Hyperbaric Oxygen
Sham Comparator: Hyperbaric Oxygen (HBO2) - 1 session; Subjects undergo 1 hyperbaric oxygen session and then 2 sham chamber sessions within 24 hours of carbon monoxide poisoning.	Combination product: Hyperbaric Oxygen (HBO2) - 1 session; During the first session, hyperbaric oxygen will be administered at 3.0 atmospheres absolute (atm abs) for 25 minutes breathing oxygen, 5 minutes air breathing, 25 minutes oxygen breathing, 5 minutes air breathing, pressure reduced to 2.0 atm abs for 30 minutes breathing oxygen, 5 minutes air breathing, and 30 minutes oxygen breathing. The second and third chamber sessions are sham sessions: room air delivered at 1.0 atmospheres absolute for 90 minutes with two sham 5-minute air breathing periods.; Other Names: HBO2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-week cognitive sequelae	Presence of cognitive sequelae at 6-week follow-up	6 weeks after poisoning

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurological examination	Presence of neurological abnormalities	6 weeks and 6 months after poisoning
Depression, anxiety or post-traumatic stress syndrome	Presence of depression, anxiety, or PTSD symptoms	6 weeks and 6 months after poisoning
Vocational assessment	Results of vocational testing	6 weeks and 6 months after poisoning
Patient self-reports of CO-related problems	Participant-reported outcome	6 weeks and 6 months

Collaborators and Investigators

• Sponsor: Intermountain Health Care, Inc.
• Collaborators: Deseret Foundation

Publications and helpful links

General Publications

• Weaver LK, Hopkins RO, Chan KJ, Churchill S, Elliott CG, Clemmer TP, Orme JF Jr, Thomas FO, Morris AH. Hyperbaric oxygen for acute carbon monoxide poisoning. N Engl J Med. 2002 Oct 3;347(14):1057-67. doi: 10.1056/NEJMoa013121.

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2007
• Primary Completion (Actual): September 10, 2016
• Study Completion (Actual): January 28, 2017

Study Registration Dates

• First Submitted: April 23, 2007
• First Submitted That Met QC Criteria: April 23, 2007
• First Posted (Estimate): April 25, 2007

Study Record Updates

• Last Update Posted (Actual): February 12, 2021
• Last Update Submitted That Met QC Criteria: February 11, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Hyperbaric oxygen therapy; Carbon monoxide poisoning; Clinical investigation
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Gas Poisoning; Poisoning; Carbon Monoxide Poisoning
• Other Study ID Numbers: 1002700

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No