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

April 8, 2010 updated by: University of Versailles

Phase 3 Study of Hyperbaric Oxygen Therapy in Non-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 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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

179

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Garches, France, 92380
        • Raymond Poincaré Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental arm
Hyperbaric oxygen therapy at 2 absolute atmosphere (1-hour plateau) followed by 4 hours of normobaric 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
Active Comparator: Control
6 hours course of normobaric oxygen therapy via a face full mask
oxygen therapy was delivered via a full face mask at high flow to achieve 100% of inspired oxygen fraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
full recovery
Time Frame: at one month
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
persistent neurological sequels
Time Frame: at one month
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
Time Frame: at one month
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
variations in carboxyhemoglobin levels
Time Frame: at 12 hours from randomization
the difference in serum carboxyhemoglobin levels between baseline values and values recorded immeadiately after study treatment completion
at 12 hours from randomization
serious adverse events
Time Frame: at one month
any complications of hyperbaric oxygen therapy
at one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 8, 2010

First Posted (Estimate)

April 9, 2010

Study Record Updates

Last Update Posted (Estimate)

April 9, 2010

Last Update Submitted That Met QC Criteria

April 8, 2010

Last Verified

April 1, 2010

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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