Trial | NCT01099995  Report issue

Title

Hyperbaric Oxygen Therapy for Comatose Patients With Acute Carbon Monoxide Poisoning
Phase 3 Study of Hyperbaric Oxygen Therapy for Comatose Patients With Acute Domestic Carbon Monoxide Poisoning

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    170
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.
Study Started
Oct 31
1989
Primary Completion
Jan 31
2000
Study Completion
Feb 29
2000
Last Update
Apr 08
2010
Estimate

Other Hyperbaric oxygen therapy [oxygen, oxygen]

one dive at 2 absolute atmosphere (1-hour plateau) with 30 min time for compression and decompression - oxygen was delivered via a full face mask at high concentration to achieve a 100% inspired fraction of oxygen or via mechanical ventilation

Other hyperbaric oxygen therapy [oxygen, oxygen]

two dives at 2 absolute atmosphere (1-hour plateau) with 30 min of compression and 30 min of decompression - oxygen being delivered via a full face mask at 100% inspired oxygen fraction or via mechanical ventilation

One HBO session Active Comparator

hyperbaric oxygen therapy one dive at 2 absolute atmosphere (1-hour plateau) - oxygen was delivered via a full face mask - followed by 4 hours of normobaric oxygen therapy

2 HBO sessions Experimental

Two sessions of hyperbaric oxygen therapy at 2 absolute atmosphere (1-hour plateau) with oxygen delivered via a full face mask at 100% inspired oxygen fraction or via mechanical ventilation

Criteria 

Inclusion Criteria:

patients older than 15 years of age
admitted for domestic CO poisoning within 12 hours after the end of CO exposure
initial coma, regardless of consciousness at hospital admission
carboxyhemoglobin level at presentation greater than 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
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
No Results Posted