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One vs. Three Hyperbaric Oxygen Treatments for Acute Carbon Monoxide Poisoning (1V3CORCT)
This study is currently recruiting participants.
Study NCT00465855   Information provided by Intermountain Health Care, Inc.
First Received: April 23, 2007   No Changes Posted

April 23, 2007
April 23, 2007
April 2007
 
6-week cognitive sequelae
Same as current
No Changes Posted
  • Neurological examination
  • Depression, anxiety or post-traumatic stress syndrome
  • Vocational assessment
  • Patient self-reports of CO-related problems
  • We will follow patients at 6 months to categorize long-term outcomes, but the prime outcome follow-up period is 6 weeks after CO poisoning.
Same as current
 
One vs. Three Hyperbaric Oxygen Treatments for Acute Carbon Monoxide Poisoning
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.

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.

Phase IV
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Carbon Monoxide Poisoning
Procedure: Hyperbaric oxygen therapy (HBO2)
 
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
200
May 2009
 

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
Both
18 Years to 79 Years
No
Contact: Lindell K. Weaver, MD 801-408-3623 lindell.weaver@intermountainmail.org
Contact: Susan K. Churchill, APRN-NP 801-408-3623 susan.churchill@intermountainmail.org
United States
 
NCT00465855
 
1002700
Intermountain Health Care, Inc.
Deseret Foundation
Principal Investigator: Lindell K Weaver, MD Intermountain Health Care, Inc.
Intermountain Health Care, Inc.
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP