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

Sponsor

Intermountain Health Care, Inc. (Other)

Overall Status

Completed

CT.gov ID

NCT00465855

Collaborator

Deseret Foundation (Other)

Enrollment

Locations

Arms

115.9

Actual Duration (Months)

37.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carbon Monoxide Poisoning	Combination Product: Hyperbaric Oxygen (HBO2) - 3 sessions Combination Product: Hyperbaric Oxygen (HBO2) - 1 session	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Randomized Trial of One Versus Three Hyperbaric Oxygen Treatments for Acute CO Poisoning

Actual Study Start Date :

Jun 3, 2007

Actual Primary Completion Date :

Sep 10, 2016

Actual Study Completion Date :

Jan 28, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Hyperbaric Oxygen (HBO2) - 3 sessions Subjects undergo 3 hyperbaric oxygen sessions within 24 hours following carbon monoxide poisoning.	Combination Product: Hyperbaric Oxygen (HBO2) - 3 sessions 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: Hyperbaric Oxygen (HBO2) - 1 session Subjects undergo 1 hyperbaric oxygen session and then 2 sham chamber sessions within 24 hours of carbon monoxide poisoning.	Combination Product: Hyperbaric Oxygen (HBO2) - 1 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. The second and third chamber sessions are sham sessions: room air delivered at 1.0 atmospheres absolute for 90 minutes with two sham 5-minute air breathing periods. Other Names: HBO2

Arm

Intervention/Treatment

Active Comparator: Hyperbaric Oxygen (HBO2) - 3 sessions

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

Combination Product: Hyperbaric Oxygen (HBO2) - 3 sessions

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: Hyperbaric Oxygen (HBO2) - 1 session

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

Combination Product: Hyperbaric Oxygen (HBO2) - 1 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. The second and third chamber sessions are sham sessions: room air delivered at 1.0 atmospheres absolute for 90 minutes with two sham 5-minute air breathing periods.

Other Names:

HBO2

Outcome Measures

Primary Outcome Measures

6-week cognitive sequelae [6 weeks after poisoning]
Presence of cognitive sequelae at 6-week follow-up

Secondary Outcome Measures

Neurological examination [6 weeks and 6 months after poisoning]
Presence of neurological abnormalities
Depression, anxiety or post-traumatic stress syndrome [6 weeks and 6 months after poisoning]
Presence of depression, anxiety, or PTSD symptoms
Vocational assessment [6 weeks and 6 months after poisoning]
Results of vocational testing
Patient self-reports of CO-related problems [6 weeks and 6 months]
Participant-reported outcome

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.