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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-03

Study Completion Date

2017-01-28

Brief Summary

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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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Detailed Description

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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.

Conditions

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Carbon Monoxide Poisoning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Hyperbaric Oxygen (HBO2) - 3 sessions

Subjects undergo 3 hyperbaric oxygen sessions within 24 hours following carbon monoxide poisoning.

Group Type ACTIVE_COMPARATOR

Hyperbaric Oxygen (HBO2) - 3 sessions

Intervention Type 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.

Hyperbaric Oxygen (HBO2) - 1 session

Subjects undergo 1 hyperbaric oxygen session and then 2 sham chamber sessions within 24 hours of carbon monoxide poisoning.

Group Type SHAM_COMPARATOR

Hyperbaric Oxygen (HBO2) - 1 session

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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Hyperbaric Oxygen HBO2 HBO HBOT HBO2

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No