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Completed

NCT Number: NCT00465855

One vs. Three Hyperbaric Oxygen Treatments for Acute Carbon Monoxide 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.

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Key information

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Intermountain LDS Hospital, Salt Lake City, Utah, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hyperbaric Oxygen (HBO2) - 3 sessions

Combination Product

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: Hyperbaric Oxygen, HBO2, HBO, HBOT

Hyperbaric Oxygen (HBO2) - 1 session

Combination Product

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

Primary outcomes

  1. 6-week cognitive sequelae

    Time frame: 6 weeks after poisoning

    Presence of cognitive sequelae at 6-week follow-up

Secondary outcomes

  1. Neurological examination

    Time frame: 6 weeks and 6 months after poisoning

    Presence of neurological abnormalities

  2. Depression, anxiety or post-traumatic stress syndrome

    Time frame: 6 weeks and 6 months after poisoning

    Presence of depression, anxiety, or PTSD symptoms

  3. Vocational assessment

    Time frame: 6 weeks and 6 months after poisoning

    Results of vocational testing

  4. Patient self-reports of CO-related problems

    Time frame: 6 weeks and 6 months

    Participant-reported outcome

Sponsors and collaborators

Lead sponsor

Intermountain Health Care, Inc.

Other

Collaborators

  • Deseret Foundation

Registry information

Official study title

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

Acronym: 1V3CORCT

Important dates

Study start
2007
Primary completion
2016
Study completion
2017
First posted
Apr 25, 2007
Registry last updated
Feb 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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