Clinical Trial: Hyperbaric Oxygen Therapy for Comatose Patients With Acute Carbon Monoxide Poisoning

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Phase 3 Study of Hyperbaric Oxygen Therapy for 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 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.

Detailed Summary:
Sponsor: University of Versailles

Current Primary Outcome: complete recovery [ Time Frame: at one month ]

Complete 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: Same as current

Current Secondary Outcome:

  • 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.
  • 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.
  • the difference in carboxyhemoglobin levels before/after treatment completion [ Time Frame: at 12 hours from randomization ]
    the difference between serum levels of carboxyhemoglobin at baseline and those recorded immedaitely after study treatment completion
  • serious adverse events [ Time Frame: at one month ]
    any complication of hyperbaric oxygen therapy


Original Secondary Outcome: Same as current

Information By: University of Versailles

Dates:
Date Received: April 5, 2010
Date Started: October 1989
Date Completion:
Last Updated: April 7, 2010
Last Verified: April 2010