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

NCT ID: NCT01100515

Last Updated: 2010-04-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 179 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 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.

Conditions

Carbon Monoxide Poisoning

Study Design

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

Study Groups

Experimental arm

Hyperbaric oxygen therapy at 2 absolute atmosphere (1-hour plateau) followed by 4 hours of normobaric oxygen therapy

Group Type: EXPERIMENTAL

Hyperbaric oxygen therapy

Intervention Type: OTHER

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

Control

6 hours course of normobaric oxygen therapy via a face full mask

Group Type: ACTIVE_COMPARATOR

normobaric oxygen therapy

Intervention Type: OTHER

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

Interventions

normobaric oxygen therapy

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

Intervention Type: OTHER

Hyperbaric 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

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.
• 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.

• 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 Assistance Publique Hôpitaux de Paris

Locations

Raymond Poincaré Hospital

Garches, , France

Countries

France

Other Identifiers

CO89

Identifier Type: -

Identifier Source: org_study_id