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

Primary Purpose

Carbon Monoxide Poisoning

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
normobaric oxygen therapy
Hyperbaric oxygen therapy
Sponsored by
University of Versailles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carbon Monoxide Poisoning focused on measuring intoxication, carbon monoxide, adults, domestic accident, acute domestic carbon monoxide poisoning

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Raymond Poincaré Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental arm

Control

Arm Description

Hyperbaric oxygen therapy at 2 absolute atmosphere (1-hour plateau) followed by 4 hours of normobaric oxygen therapy

6 hours course of normobaric oxygen therapy via a face full mask

Outcomes

Primary Outcome Measures

full recovery
Full 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
variations in carboxyhemoglobin levels
the difference in serum carboxyhemoglobin levels between baseline values and values recorded immeadiately after study treatment completion
serious adverse events
any complications of hyperbaric oxygen therapy

Full Information

First Posted
April 5, 2010
Last Updated
April 8, 2010
Sponsor
University of Versailles
Collaborators
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT01100515
Brief Title
Hyperbaric Oxygen Therapy for Acute Domestic Carbon Monoxide (CO) Poisoning
Official Title
Phase 3 Study of Hyperbaric Oxygen Therapy in Non-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
this study was suspended for futility
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carbon Monoxide Poisoning
Keywords
intoxication, carbon monoxide, adults, domestic accident, 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
179 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental arm
Arm Type
Experimental
Arm Description
Hyperbaric oxygen therapy at 2 absolute atmosphere (1-hour plateau) followed by 4 hours of normobaric oxygen therapy
Arm Title
Control
Arm Type
Active Comparator
Arm Description
6 hours course of normobaric oxygen therapy via a face full mask
Intervention Type
Other
Intervention Name(s)
normobaric oxygen therapy
Intervention Description
oxygen therapy was delivered via a full face mask at high flow to achieve 100% of inspired oxygen fraction
Intervention Type
Other
Intervention Name(s)
Hyperbaric oxygen therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
full recovery
Description
Full 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
variations in carboxyhemoglobin levels
Description
the difference in serum carboxyhemoglobin levels between baseline values and values recorded immeadiately after study treatment completion
Time Frame
at 12 hours from randomization
Title
serious adverse events
Description
any complications 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. 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.
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 Acute Domestic Carbon Monoxide (CO) Poisoning

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