One vs. Three Hyperbaric Oxygen Treatments for Acute Carbon Monoxide Poisoning - Full Text View

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

First Received: April 23, 2007 No Changes Posted

Sponsor:	Intermountain Health Care, Inc.
Collaborator:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Carbon Monoxide Poisoning Poisoning

Drug Information available for: Carbon monoxide

U.S. FDA Resources

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:

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.

Study ID Numbers:	1002700
Study First Received:	April 23, 2007
Last Updated:	April 23, 2007
ClinicalTrials.gov Identifier:	NCT00465855 History of Changes
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

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Carbon Monoxide Poisoning
Poisoning

Carbon Monoxide
Disorders of Environmental Origin
Gas Poisoning
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 22, 2009