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

NCT01100515 | Terminated Phase 3

• 1 other identifier: CO89
• Study Type: interventional
• Target: 179
• 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 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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• full recovery

  Full 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

• variations in carboxyhemoglobin levels

  at 12 hours from randomization

• serious adverse events

  at one month

Study Arms (2)

Experimental arm

EXPERIMENTAL

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

Other: Hyperbaric oxygen therapy

Control

ACTIVE COMPARATOR

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

Other: normobaric oxygen therapy

Interventions

normobaric oxygen therapy OTHER

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

Control

Hyperbaric oxygen therapy 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

Experimental arm

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.
• had transient loss of consciousness (syncope, malaise)
• carboxyhemoglobin level at presentation \>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
• 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.

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

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Gas Poisoning; Poisoning; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

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 9, 2010
• Study Start: October 1, 1989
• Primary Completion: January 1, 2000
• Study Completion: February 1, 2000
• Last Updated: April 9, 2010

Record last verified: 2010-04

Locations

FR (1)