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

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

Official Title: Phase 3 Study of Hyperbaric Oxygen Therapy in Non-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 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.

Detailed Summary:
Sponsor: University of Versailles

Current Primary Outcome: 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).


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
  • 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
  • serious adverse events [ Time Frame: at one month ]
    any complications 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 8, 2010
Last Verified: April 2010