Hyperbaric Oxygen Therapy for Comatose Patients With Acute Carbon Monoxide Poisoning

NCT01099995 | Terminated Phase 3

• 1 other identifier: CO89-2
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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

Keywords

domestic accident; coma; carbon monoxide; intoxication; acute domestic carbon monoxide poisoning

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• persistent neurological sequels

  at one month

• delayed neurological sequels

  at one month

• the difference in carboxyhemoglobin levels before/after treatment completion

  at 12 hours from randomization

• serious adverse events

  at one month

Study Arms (2)

One HBO session

ACTIVE COMPARATOR

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

2 HBO sessions

EXPERIMENTAL

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

Interventions

hyperbaric oxygen therapy 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

One HBO session

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Versailles: lead
• Assistance Publique - Hôpitaux de Paris: collaborator

Study Sites (1)

Raymond Poincaré Hospital

Garches, 92380, France

Location

MeSH Terms

Conditions

Carbon Monoxide Poisoning; Coma

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Gas Poisoning; Poisoning; Chemically-Induced Disorders; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Djillali Annane, MD

  Assistance Publique - Hôpitaux de Paris

  STUDY CHAIR

• Jean Claude Raphael

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 5, 2010
• First Posted: April 8, 2010
• Study Start: October 1, 1989
• Primary Completion: January 1, 2000
• Study Completion: February 1, 2000
• Last Updated: April 8, 2010

Record last verified: 2010-04

Locations

FR (1)