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

Sponsor:	Intermountain Health Care, Inc.
Collaborator:	Deseret Foundation
Information provided by (Responsible Party):	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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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 Oxygen Therapy 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 [ Time Frame: 6 weeks after poisoning ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Neurological examination [ Time Frame: 6 weeks and 6 months after poisoning ] [ Designated as safety issue: No ]
Depression, anxiety or post-traumatic stress syndrome [ Time Frame: 6 weeks and 6 months after poisoning ] [ Designated as safety issue: No ]
Vocational assessment [ Time Frame: 6 weeks and 6 months after poisoning ] [ Designated as safety issue: No ]
Patient self-reports of CO-related problems [ Time Frame: 6 weeks and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	April 2007
Estimated Study Completion Date:	May 2013
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 3 hyperbaric oxygen sessions Subjects undergo 3 hyperbaric oxygen sessions within 24 hours following carbon monoxide poisoning.	Procedure: Hyperbaric oxygen therapy (HBO2) 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. Other Names: Hyperbaric Oxygen HBO2 HBO HBOT
Sham Comparator: 1 hyperbaric oxygen session Subjects undergo 1 hyperbaric oxygen session and then 2 sham chamber sessions within 24 hours of carbon monoxide poisoning.	Procedure: Hyperbaric oxygen therapy (HBO2) 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. Other Names: Hyperbaric Oxygen HBO2 HBO HBOT

Arms

Assigned Interventions

Active Comparator: 3 hyperbaric oxygen sessions

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

Procedure: Hyperbaric oxygen therapy (HBO2)

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.

Other Names:

Hyperbaric Oxygen
HBO2
HBO
HBOT

Sham Comparator: 1 hyperbaric oxygen session

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

Procedure: Hyperbaric oxygen therapy (HBO2)

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.

Other Names:

Hyperbaric Oxygen
HBO2
HBO
HBOT

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
History of 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.

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	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.

Responsible Party:	Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier:	NCT00465855 History of Changes
Other Study ID Numbers:	1002700
Study First Received:	April 23, 2007
Last Updated:	October 3, 2011
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:

Carbon Monoxide Poisoning
Poisoning
Gas Poisoning
Substance-Related Disorders

Carbon Monoxide
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012