Hyperbaric Oxygen Therapy for Comatose Patients With Acute Carbon Monoxide Poisoning

NCT ID: NCT01099995

Last Updated: 2010-04-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1989-10-31
• Study Completion Date: 2000-02-29

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.

Conditions

Carbon Monoxide Poisoning

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Hyperbaric oxygen therapy

Intervention Type: OTHER

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

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

Group Type: EXPERIMENTAL

hyperbaric oxygen therapy

Intervention Type: OTHER

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

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: collaborator

University of Versailles

OTHER

Sponsor Role: lead

Responsible Party

DRRC AP-HP

Principal Investigators

Djillali Annane, MD

Role: STUDY_CHAIR

Assistance Publique - Hôpitaux de Paris

Jean Claude Raphael

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Raymond Poincaré Hospital

Garches, , France

Countries

France

Other Identifiers

CO89-2

Identifier Type: -

Identifier Source: org_study_id