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Role of Pulse Co-oximetry for Detecting Carbon Monoxide Poisoning in the Prehospital Emergency Medical Service Setting (CO-OX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02860455
Recruitment Status : Unknown
Verified August 2016 by University Hospital, Montpellier.
Recruitment status was:  Recruiting
First Posted : August 9, 2016
Last Update Posted : August 9, 2016
French Society of Emergency Medicine
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:

The RAD-57 pulse CO-oximeter is a lightweight device allowing non-invasive measurement of blood carboxyhemoglobin. Previous studies comparing RAD-57 measurements (SpCO) to standard laboratory blood gas analysis (COHb) have reported contradictory results.

the RAD-57 pulse CO-oximeter could be useful as a first-line screening test for acute CO poisoning, enabling rapid detection and management of patients with suspected CO poisoning in the prehospital emergency setting This study assesses the diagnostic value of pulse CO-oximetry, comparing SpCO to standard laboratory blood measurement for prehospital management of patients with suspected carbon monoxide (CO) poisoning.

Condition or disease Intervention/treatment Phase
Carbon Monoxide Poisoning Device: RAD57 measurement (SpCO) Device: CO-oximeter Not Applicable

Detailed Description:
Transcutaneous SpCO will be obtained using the RAD-57 simultaneously with blood sampling for laboratory blood gas analysis, at the time of prehospital management by emergency medical services. The diagnostic performance of SpCO for the screening of CO poisoning will be determined using ROC curve analysis, and Blood COHb levels >5% and 10% as the reference standard for CO poisonning for non-smokers and smokers respectively. Correlation between SpCO and COHb will be assessed using Bland and Altman's method.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 176 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Role of Pulse Co-oximetry in Prehospital Emergency Medical Service Management of Suspected Carbon Monoxide Poisoning : A Prospective Multicenter Study.
Study Start Date : February 2012
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
SpCO and COHb measurement

SpCO measurement (Experimental) : Non invasive pulse CO-oximetry will be carried out in all patients simultaneously with venous blood sampling for standard laboratory blood gas analysis, at time of prehospital management by emergency medical services

COHb measurement (Active comparator) : Blood carboxyhemoglobin testing will be carried out in all patients

Device: RAD57 measurement (SpCO)

SpCO measurement (Experimental)

Non invasive pulse CO-oximetry will be carried out by prehospital emergency nursing staff trained in the use of the Rad-57 pulse CO-oximeter (Masimo, Inc., Irvine, CA, USA), using the adult sized sensor (Sensor, Rev. B) placed on the 3rd or 4th digit, according to manufacturer recommendations. Nail polish will be removed if necessary. SpCO was expressed in total percentage of hemoglobin.

Other Name: Non invasive pulse CO-oximetry

Device: CO-oximeter

COHb measurement (Active Comparator)

Venous blood will be collected into EDTA treated tubes (Beckton Dickinson) prehospitally and sent to the toxicology laboratory for further carboxyhemoglobin testing. Blood carboxyhemoglobin will be analyzed by derivative spectrophotometry using an automated CO-oximeter (IL 682, Instrumentation Laboratory SpA V.le Monza 338-20128 Milan, Italy). Blood carboxyhemoglobin will be detected within a range of 0-100% and accuracy of 0.5% and reported as percentage of total haemoglobin.

Primary Outcome Measures :
  1. SpCO optimal threshold value for detection of CO poisoning [ Time Frame: Baseline ]
    prehospital medical management

Secondary Outcome Measures :
  1. SpCO level [ Time Frame: Baseline ]
    prehospital medical management

  2. COHb Blood carboxyhemoglobin level [ Time Frame: Baseline ]
    prehospital medical management

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Patient aged 18 years or older
  • Patient managed by prehospital emergency medical services.
  • Patient with a suspected CO exposure presenting or not with clinical signs of CO poisoning

Exclusion criteria:

  • Patient for whom venous blood sampling cannot be obtained prehospitally
  • Patient for whom SpCo measurement cannot be performed prehospitally (cardiac arrest, peripheral vasoconstriction)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02860455

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Contact: Mustapha Sebbane, MD, PhD 0467337974

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Montpellier University hospital - Emergency department Recruiting
Montpellier, France, 34295
Contact: Mustapha Sebbane, MD, Ph.D    0467337974   
Sponsors and Collaborators
University Hospital, Montpellier
French Society of Emergency Medicine
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Principal Investigator: Mustapha Sebbane, MD, PhD Montpellier University hospital - Emergency department

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Responsible Party: University Hospital, Montpellier Identifier: NCT02860455     History of Changes
Other Study ID Numbers: 8869
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: August 9, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University Hospital, Montpellier:
CO poisoning
Pulse oximetry
Carbon monoxide saturation (SpCO)
Emergency Department
Additional relevant MeSH terms:
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Carbon Monoxide Poisoning
Disease Attributes
Pathologic Processes
Chemically-Induced Disorders
Gas Poisoning
Carbon Monoxide
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs