Hyperbaric Oxygen Therapy for Comatose Patients With Acute Carbon Monoxide Poisoning
Primary Purpose
Carbon Monoxide Poisoning
Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Hyperbaric oxygen therapy
hyperbaric oxygen therapy
Sponsored by
About this trial
This is an interventional treatment trial for Carbon Monoxide Poisoning focused on measuring domestic accident, coma, carbon monoxide, intoxication, acute domestic carbon monoxide poisoning
Eligibility Criteria
Inclusion Criteria:
- patients older than 15 years of age
- admitted for domestic CO poisoning within 12 hours after the end of CO exposure
- initial coma, regardless of consciousness at hospital admission
- carboxyhemoglobin level at presentation greater than 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
- 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
Sites / Locations
- Raymond Poincaré Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
One HBO session
2 HBO sessions
Arm Description
hyperbaric oxygen therapy one dive at 2 absolute atmosphere (1-hour plateau) - oxygen was delivered via a full face mask - followed by 4 hours of normobaric oxygen therapy
Two sessions of hyperbaric oxygen therapy at 2 absolute atmosphere (1-hour plateau) with oxygen delivered via a full face mask at 100% inspired oxygen fraction or via mechanical ventilation
Outcomes
Primary Outcome Measures
complete recovery
Complete recovery was defined as an absence of symptoms reported on the self-assessment questionnaire with a normal physical exam (including normal neuropsychological functions).
Secondary Outcome Measures
persistent neurological sequels
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
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.
the difference in carboxyhemoglobin levels before/after treatment completion
the difference between serum levels of carboxyhemoglobin at baseline and those recorded immedaitely after study treatment completion
serious adverse events
any complication of hyperbaric oxygen therapy
Full Information
NCT ID
NCT01099995
First Posted
April 5, 2010
Last Updated
April 7, 2010
Sponsor
University of Versailles
Collaborators
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT01099995
Brief Title
Hyperbaric Oxygen Therapy for Comatose Patients With Acute Carbon Monoxide Poisoning
Official Title
Phase 3 Study of Hyperbaric Oxygen Therapy for Comatose Patients With Acute Domestic Carbon Monoxide Poisoning
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Terminated
Why Stopped
the study was halted after the first interim analysis as there were significantly more patients who recovered at one month in the control arm
Study Start Date
October 1989 (undefined)
Primary Completion Date
January 2000 (Actual)
Study Completion Date
February 2000 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Versailles
Collaborators
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 two sessions of HBO at 2 absolute atmosphere and one session of HBO at 2 absolute atmosphere followed by 4 hours of normobaric oxygen therapy in comatose adult victims of acute domestic carbon monoxide poisoning.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carbon Monoxide Poisoning
Keywords
domestic accident, coma, carbon monoxide, intoxication, acute domestic carbon monoxide poisoning
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
170 (Actual)
8. Arms, Groups, and Interventions
Arm Title
One HBO session
Arm Type
Active Comparator
Arm Description
hyperbaric oxygen therapy one dive at 2 absolute atmosphere (1-hour plateau) - oxygen was delivered via a full face mask - followed by 4 hours of normobaric oxygen therapy
Arm Title
2 HBO sessions
Arm Type
Experimental
Arm Description
Two sessions of hyperbaric oxygen therapy at 2 absolute atmosphere (1-hour plateau) with oxygen delivered via a full face mask at 100% inspired oxygen fraction or via mechanical ventilation
Intervention Type
Other
Intervention Name(s)
Hyperbaric oxygen therapy
Intervention Description
one dive at 2 absolute atmosphere (1-hour plateau) with 30 min time for compression and decompression - oxygen was delivered via a full face mask at high concentration to achieve a 100% inspired fraction of oxygen or via mechanical ventilation
Intervention Type
Other
Intervention Name(s)
hyperbaric oxygen therapy
Intervention Description
two dives at 2 absolute atmosphere (1-hour plateau) with 30 min of compression and 30 min of decompression - oxygen being delivered via a full face mask at 100% inspired oxygen fraction or via mechanical ventilation
Primary Outcome Measure Information:
Title
complete recovery
Description
Complete recovery was defined as an absence of symptoms reported on the self-assessment questionnaire with a normal physical exam (including normal neuropsychological functions).
Time Frame
at one month
Secondary Outcome Measure Information:
Title
persistent neurological sequels
Description
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.
Time Frame
at one month
Title
delayed neurological sequels
Description
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.
Time Frame
at one month
Title
the difference in carboxyhemoglobin levels before/after treatment completion
Description
the difference between serum levels of carboxyhemoglobin at baseline and those recorded immedaitely after study treatment completion
Time Frame
at 12 hours from randomization
Title
serious adverse events
Description
any complication of hyperbaric oxygen therapy
Time Frame
at one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients older than 15 years of age
admitted for domestic CO poisoning within 12 hours after the end of CO exposure
initial coma, regardless of consciousness at hospital admission
carboxyhemoglobin level at presentation greater than 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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Djillali Annane, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jean Claude Raphael
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Raymond Poincaré Hospital
City
GArches
ZIP/Postal Code
92380
Country
France
12. IPD Sharing Statement
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Hyperbaric Oxygen Therapy for Comatose Patients With Acute Carbon Monoxide Poisoning
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