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

Primary Purpose

Carbon Monoxide Poisoning

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Hyperbaric Oxygen (HBO2) - 3 sessions
Hyperbaric Oxygen (HBO2) - 1 session
Sponsored by
Intermountain Health Care, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carbon Monoxide Poisoning focused on measuring Carbon monoxide poisoning, Hyperbaric oxygen therapy, Randomized controlled trial, Clinical investigation

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Intermountain LDS Hospital
  • Intermountain Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Hyperbaric Oxygen (HBO2) - 3 sessions

Hyperbaric Oxygen (HBO2) - 1 session

Arm Description

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

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

Outcomes

Primary Outcome Measures

6-week cognitive sequelae
Presence of cognitive sequelae at 6-week follow-up

Secondary Outcome Measures

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

Full Information

First Posted
April 23, 2007
Last Updated
February 11, 2021
Sponsor
Intermountain Health Care, Inc.
Collaborators
Deseret Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00465855
Brief Title
One vs. Three Hyperbaric Oxygen Treatments for Acute Carbon Monoxide Poisoning
Acronym
1V3CORCT
Official Title
Randomized Trial of One Versus Three Hyperbaric Oxygen Treatments for Acute CO Poisoning
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 3, 2007 (Actual)
Primary Completion Date
September 10, 2016 (Actual)
Study Completion Date
January 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intermountain Health Care, Inc.
Collaborators
Deseret Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carbon Monoxide Poisoning
Keywords
Carbon monoxide poisoning, Hyperbaric oxygen therapy, Randomized controlled trial, Clinical investigation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hyperbaric Oxygen (HBO2) - 3 sessions
Arm Type
Active Comparator
Arm Description
Subjects undergo 3 hyperbaric oxygen sessions within 24 hours following carbon monoxide poisoning.
Arm Title
Hyperbaric Oxygen (HBO2) - 1 session
Arm Type
Sham Comparator
Arm Description
Subjects undergo 1 hyperbaric oxygen session and then 2 sham chamber sessions within 24 hours of carbon monoxide poisoning.
Intervention Type
Combination Product
Intervention Name(s)
Hyperbaric Oxygen (HBO2) - 3 sessions
Other Intervention Name(s)
Hyperbaric Oxygen, HBO2, HBO, HBOT
Intervention Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Hyperbaric Oxygen (HBO2) - 1 session
Other Intervention Name(s)
HBO2
Intervention Description
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.
Primary Outcome Measure Information:
Title
6-week cognitive sequelae
Description
Presence of cognitive sequelae at 6-week follow-up
Time Frame
6 weeks after poisoning
Secondary Outcome Measure Information:
Title
Neurological examination
Description
Presence of neurological abnormalities
Time Frame
6 weeks and 6 months after poisoning
Title
Depression, anxiety or post-traumatic stress syndrome
Description
Presence of depression, anxiety, or PTSD symptoms
Time Frame
6 weeks and 6 months after poisoning
Title
Vocational assessment
Description
Results of vocational testing
Time Frame
6 weeks and 6 months after poisoning
Title
Patient self-reports of CO-related problems
Description
Participant-reported outcome
Time Frame
6 weeks and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lindell K Weaver, MD
Organizational Affiliation
Intermountain Health Care, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Intermountain LDS Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Facility Name
Intermountain Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84157-7000
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12362006
Citation
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. doi: 10.1056/NEJMoa013121.
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One vs. Three Hyperbaric Oxygen Treatments for Acute Carbon Monoxide Poisoning

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