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

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 Overview

• Status: Terminated
• Conditions: Carbon Monoxide Poisoning
• Intervention / Treatment: Other: Hyperbaric oxygen therapy; Other: hyperbaric oxygen therapy

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • GArches, France, 92380
    • Raymond Poincaré Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: One HBO session; 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	Other: Hyperbaric 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
Experimental: 2 HBO sessions; 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	Other: hyperbaric 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complete recovery	Complete recovery was defined as an absence of symptoms reported on the self-assessment questionnaire with a normal physical exam (including normal neuropsychological functions).	at one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
persistent neurological sequels	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.	at one month
delayed neurological sequels	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.	at one month
the difference in carboxyhemoglobin levels before/after treatment completion	the difference between serum levels of carboxyhemoglobin at baseline and those recorded immedaitely after study treatment completion	at 12 hours from randomization
serious adverse events	any complication of hyperbaric oxygen therapy	at one month

Collaborators and Investigators

• Sponsor: University of Versailles
• Collaborators: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Chair: Djillali Annane, MD, Assistance Publique - Hôpitaux de Paris; Principal Investigator: Jean Claude Raphael, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start: October 1, 1989
• Primary Completion (Actual): January 1, 2000
• Study Completion (Actual): February 1, 2000

Study Registration Dates

• First Submitted: April 5, 2010
• First Submitted That Met QC Criteria: April 7, 2010
• First Posted (Estimate): April 8, 2010

Study Record Updates

• Last Update Posted (Estimate): April 8, 2010
• Last Update Submitted That Met QC Criteria: April 7, 2010
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Keywords: intoxication; coma; carbon monoxide; domestic accident; acute domestic carbon monoxide poisoning
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Gas Poisoning; Poisoning; Carbon Monoxide Poisoning
• Other Study ID Numbers: CO89-2