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

Phase 3 Study of Hyperbaric Oxygen Therapy in Non-Comatose Patients With Acute Domestic Carbon Monoxide Poisoning

Status
Terminated
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01100515
Enrollment
179
Registered
2010-04-09
Start date
1989-10-31
Completion date
2000-02-29
Last updated
2010-04-09

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

Conditions

Carbon Monoxide Poisoning

Keywords

intoxication, carbon monoxide, adults, domestic accident, 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.

Interventions

oxygen therapy was delivered via a full face mask at high flow to achieve 100% of inspired oxygen fraction

OTHERHyperbaric 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

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. * 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.

Design outcomes

Primary

MeasureTime frameDescription
full recoveryat one monthFull 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
variations in carboxyhemoglobin levelsat 12 hours from randomizationthe difference in serum carboxyhemoglobin levels between baseline values and values recorded immeadiately after study treatment completion
serious adverse eventsat one monthany complications of hyperbaric oxygen therapy

Countries

France

Outcome results

None listed

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