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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
  Purpose

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.


Condition Intervention Phase
Carbon Monoxide Poisoning
 Other: normobaric oxygen therapy
Other: Hyperbaric oxygen therapy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 3 Study of Hyperbaric Oxygen Therapy in Non-Comatose Patients With Acute Domestic Carbon Monoxide Poisoning

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Versailles:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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


Enrollment: 179
Study Start Date: October 1989
Study Completion Date: February 2000
Primary Completion Date: January 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental arm
Hyperbaric oxygen therapy at 2 absolute atmosphere (1-hour plateau) followed by 4 hours of normobaric oxygen therapy
 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
Active Comparator: Control
6 hours course of normobaric oxygen therapy via a face full mask
 Other: normobaric oxygen therapy
oxygen therapy was delivered via a full face mask at high flow to achieve 100% of inspired oxygen fraction

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01100515

Locations
France
Raymond Poincaré Hospital
Garches, France, 92380
Sponsors and Collaborators
University of Versailles
Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Christophe Misse, DRRC Assistance Publique Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01100515     History of Changes
Other Study ID Numbers: CO89
Study First Received: April 5, 2010
Last Updated: April 8, 2010
Health Authority: France: Direction Générale de la Santé

Keywords provided by University of Versailles:
intoxication
carbon monoxide
adults
domestic accident
acute domestic carbon monoxide poisoning

Additional relevant MeSH terms:
Carbon Monoxide Poisoning
Poisoning
Gas Poisoning
Substance-Related Disorders
 Carbon Monoxide
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013