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

This study is currently recruiting participants.
Verified by Intermountain Health Care, Inc., April 2007

Sponsors and Collaborators: Intermountain Health Care, Inc.
Deseret Foundation
Information provided by: Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT00465855
  Purpose

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.


Condition Intervention Phase
Carbon Monoxide Poisoning
Procedure: Hyperbaric oxygen therapy (HBO2)
Phase IV

MedlinePlus related topics:   Carbon Monoxide Poisoning    Poisoning   

ChemIDplus related topics:   Carbon monoxide   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:   Randomized Trial of One Versus Three Hyperbaric Oxygen Treatments for Acute CO Poisoning

Further study details as provided by Intermountain Health Care, Inc.:

Primary Outcome Measures:
  • 6-week cognitive sequelae

Secondary Outcome Measures:
  • 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.

Estimated Enrollment:   200
Study Start Date:   April 2007
Estimated Study Completion Date:   May 2009

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
Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00465855

Contacts
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    

Locations
United States, Utah
Intermountain LDS Hospital     Recruiting
      Salt Lake City, Utah, United States, 84143
Intermountain Medical Center     Not yet recruiting
      Salt Lake City, Utah, United States, 84157-7000

Sponsors and Collaborators
Intermountain Health Care, Inc.
Deseret Foundation

Investigators
Principal Investigator:     Lindell K Weaver, MD     Intermountain Health Care, Inc.    
  More Information

Publications:

Study ID Numbers:   1002700
First Received:   April 23, 2007
Last Updated:   April 23, 2007
ClinicalTrials.gov Identifier:   NCT00465855
Health Authority:   United States: Institutional Review Board

Keywords provided by Intermountain Health Care, Inc.:
Carbon monoxide poisoning  
Hyperbaric oxygen therapy  
Randomized controlled trial  
Clinical investigation  

Study placed in the following topic categories:
Carbon Monoxide Poisoning
Poisoning
Carbon Monoxide
Disorders of Environmental Origin

Additional relevant MeSH terms:
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gas Poisoning
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 29, 2008




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