Hyperbaric Oxygen Therapy for Acute Domestic Carbon Monoxide (CO) Poisoning

This study has been terminated.

(this study was suspended for futility)

Sponsor:

Collaborator:

Assistance Publique - Hôpitaux de Paris

Information provided by:

University of Versailles

ClinicalTrials.gov Identifier:

NCT01100515

First received: April 5, 2010

Last updated: April 8, 2010

Last verified: April 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	April 5, 2010
Last Updated Date	April 8, 2010
Start Date ^ICMJE	October 1989
Primary Completion Date	January 2000 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 8, 2010)	full recovery [ Time Frame: at one month ] [ Designated as safety issue: No ] Full recovery was defined as an absence of symptoms reported on the self-assessment questionnaire with a normal physical exam (including normal neuropsychological functions).
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01100515 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 8, 2010)	persistent neurological sequels [ Time Frame: at one month ] [ Designated as safety issue: Yes ] Neurological sequels were considered persistent (PNS) if they were present both at hospital discharge and at one-month evaluation, regardless of the type of manifestation delayed neurological sequels [ Time Frame: at one month ] [ Designated as safety issue: Yes ] Delayed neurological sequelae (DNS) were any neurological manifestations that appeared between hospital discharge and one-month evaluation, regardless of their severity. Patients with DNS were those considered fully recovered at hospital discharge but with neurological manifestations at one-month evaluation variations in carboxyhemoglobin levels [ Time Frame: at 12 hours from randomization ] [ Designated as safety issue: No ] the difference in serum carboxyhemoglobin levels between baseline values and values recorded immeadiately after study treatment completion serious adverse events [ Time Frame: at one month ] [ Designated as safety issue: Yes ] any complications of hyperbaric oxygen therapy
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Hyperbaric Oxygen Therapy for Acute Domestic Carbon Monoxide (CO) Poisoning
Official Title ^ICMJE	Phase 3 Study of Hyperbaric Oxygen Therapy in Non-Comatose Patients With Acute Domestic Carbon Monoxide Poisoning
Brief Summary	Carbon monoxide poisoning still places a burden on the healthcare system worldwide. While oxygen therapy is the cornerstone treatment, the role and practical modalities of hyperbaric oxygen therapy (HBO) remain controversial. This study aimed at comparing one session of HBO at 2 absolute atmosphere followed by 4 hours of normobaric oxygen therapy to 6 hours of normobaric oxygen therapy in adult victims of acute domestic carbon monoxide poisoning and without coma.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Carbon Monoxide Poisoning
Intervention ^ICMJE	Other: normobaric oxygen therapy oxygen therapy was delivered via a full face mask at high flow to achieve 100% of inspired oxygen fraction Other: Hyperbaric oxygen therapy Hyperbaric oxygen therapy was delivered in a hyperbaric chamber, pressurized at 2 absolute atmosphere (1 hour plateau) and the patient breathed high oxygen concentration via a full face mask followed by 4 hours of normobaric oxygen therapy
Study Arm (s)	Experimental: Experimental arm Hyperbaric oxygen therapy at 2 absolute atmosphere (1-hour plateau) followed by 4 hours of normobaric oxygen therapy Intervention: Other: Hyperbaric oxygen therapy Active Comparator: Control 6 hours course of normobaric oxygen therapy via a face full mask Intervention: Other: normobaric oxygen therapy
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	179
Completion Date	February 2000
Primary Completion Date	January 2000 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: patients older than 15 years of age admitted for domestic CO poisoning within 12 hours after the end of CO exposure. had transient loss of consciousness (syncope, malaise) carboxyhemoglobin level at presentation >10% or 5%, in smokers and non-smokers, respectively. Exclusion Criteria: poisoning by more than one compound (e.g., CO plus a drug or CO plus other toxic gases such as those found in fire smoke suicide attempt pregnancy coma contraindications to HBO (circulatory collapse or pneumothorax) technical obstacles to HBO non domestic CO poisoning difficulty in determining whether the patient experienced initial loss of consciousness or initial coma consent refusal.
Gender	Both
Ages	15 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	France

Administrative Information
NCT Number ^ICMJE	NCT01100515
Other Study ID Numbers ^ICMJE	CO89
Has Data Monitoring Committee	No
Responsible Party	Christophe Misse, DRRC Assistance Publique Hôpitaux de Paris
Study Sponsor ^ICMJE	University of Versailles
Collaborators ^ICMJE	Assistance Publique - Hôpitaux de Paris
Investigators ^ICMJE	Not Provided
Information Provided By	University of Versailles
Verification Date	April 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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