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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00465855
Other study ID # 1002700
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date June 3, 2007
Est. completion date January 28, 2017

Study information

Verified date February 2021
Source Intermountain Health Care, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date January 28, 2017
Est. primary completion date September 10, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 79 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States Intermountain LDS Hospital Salt Lake City Utah
United States Intermountain Medical Center Salt Lake City Utah

Sponsors (2)

Lead Sponsor Collaborator
Intermountain Health Care, Inc. Deseret Foundation

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 6-week cognitive sequelae Presence of cognitive sequelae at 6-week follow-up 6 weeks after poisoning
Secondary Neurological examination Presence of neurological abnormalities 6 weeks and 6 months after poisoning
Secondary Depression, anxiety or post-traumatic stress syndrome Presence of depression, anxiety, or PTSD symptoms 6 weeks and 6 months after poisoning
Secondary Vocational assessment Results of vocational testing 6 weeks and 6 months after poisoning
Secondary Patient self-reports of CO-related problems Participant-reported outcome 6 weeks and 6 months
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