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

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ClinicalTrials.gov Identifier: NCT01100515
Recruitment Status : Terminated (this study was suspended for futility)
First Posted : April 9, 2010
Last Update Posted : April 9, 2010
Sponsor:
Collaborator:
Assistance Publique - Hôpitaux de Paris
Information provided by:
University of Versailles

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.

Condition or disease Intervention/treatment Phase
Carbon Monoxide Poisoning Other: normobaric oxygen therapy Other: Hyperbaric oxygen therapy Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 179 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 3 Study of Hyperbaric Oxygen Therapy in Non-Comatose Patients With Acute Domestic Carbon Monoxide Poisoning
Study Start Date : October 1989
Actual Primary Completion Date : January 2000
Actual Study Completion Date : February 2000

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Arm Intervention/treatment
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




Primary Outcome Measures :
  1. full recovery [ Time Frame: at one month ]
    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 :
  1. persistent neurological sequels [ Time Frame: at one month ]
    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

  2. delayed neurological sequels [ Time Frame: at one month ]
    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

  3. variations in carboxyhemoglobin levels [ Time Frame: at 12 hours from randomization ]
    the difference in serum carboxyhemoglobin levels between baseline values and values recorded immeadiately after study treatment completion

  4. serious adverse events [ Time Frame: at one month ]
    any complications of hyperbaric oxygen therapy



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01100515


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

Responsible Party: Christophe Misse, DRRC Assistance Publique Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01100515     History of Changes
Other Study ID Numbers: CO89
First Posted: April 9, 2010    Key Record Dates
Last Update Posted: April 9, 2010
Last Verified: April 2010

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

Additional relevant MeSH terms:
Poisoning
Carbon Monoxide Poisoning
Chemically-Induced Disorders
Gas Poisoning
Carbon Monoxide
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gasotransmitters
Neurotransmitter Agents
Physiological Effects of Drugs