Clinical trial NCT00465855: One vs. Three Hyperbaric Oxygen Treatments for Acute Carbon Monoxide Poisoning
Official title: Randomized Trial of One Versus Three Hyperbaric Oxygen Treatments for Acute CO Poisoning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Carbon Monoxide Poisoning
Keywords: Carbon monoxide poisoning
Hyperbaric oxygen therapy
Randomized controlled trial
Clinical investigation
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
Collaborators: name: Deseret Foundation
First posted: 2007-04-25
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 6-week cognitive sequelae
timeFrame: 6 weeks after poisoning
Secondary outcomes:
measure: Neurological examination
timeFrame: 6 weeks and 6 months after poisoning
measure: Depression, anxiety or post-traumatic stress syndrome
timeFrame: 6 weeks and 6 months after poisoning
measure: Vocational assessment
timeFrame: 6 weeks and 6 months after poisoning
measure: Patient self-reports of CO-related problems
timeFrame: 6 weeks and 6 months
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Intermountain LDS Hospital
state: Utah
city: Salt Lake City
country: United States
facility: Intermountain Medical Center
state: Utah
Study officials:
affiliation: Intermountain Health Care, Inc.
name: Lindell K Weaver, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.