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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

Status
Terminated
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01099995
Enrollment
170
Registered
2010-04-08
Start date
1989-10-31
Completion date
2000-02-29
Last updated
2010-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carbon Monoxide Poisoning

Keywords

domestic accident, coma, carbon monoxide, intoxication, 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.

Interventions

OTHERHyperbaric oxygen therapy

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

OTHERhyperbaric oxygen therapy

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

Sponsors

Assistance Publique - Hôpitaux de Paris
CollaboratorOTHER
University of Versailles
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
complete recoveryat one monthComplete recovery was defined as an absence of symptoms reported on the self-assessment questionnaire with a normal physical exam (including normal neuropsychological functions).

Secondary

MeasureTime frameDescription
persistent neurological sequelsat one monthNeurological 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 sequelsat one monthDelayed 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 completionat 12 hours from randomizationthe difference between serum levels of carboxyhemoglobin at baseline and those recorded immedaitely after study treatment completion
serious adverse eventsat one monthany complication of hyperbaric oxygen therapy

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026