Role of Pulse Co-oximetry for Detecting Carbon Monoxide Poisoning in the Prehospital Emergency Medical Service Setting (CO-OX)
Primary Purpose
Carbon Monoxide Poisoning
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
RAD57 measurement (SpCO)
CO-oximeter
Sponsored by
About this trial
This is an interventional diagnostic trial for Carbon Monoxide Poisoning focused on measuring CO poisoning, CO-oximetry, Pulse oximetry, Carbon monoxide saturation (SpCO), Emergency Department, Sensitivity, Specificity
Eligibility Criteria
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)
Sites / Locations
- Montpellier University hospital - Emergency departmentRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
SpCO and COHb measurement
Arm Description
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
Outcomes
Primary Outcome Measures
SpCO optimal threshold value for detection of CO poisoning
prehospital medical management
Secondary Outcome Measures
SpCO level
prehospital medical management
COHb Blood carboxyhemoglobin level
prehospital medical management
Full Information
NCT ID
NCT02860455
First Posted
August 2, 2016
Last Updated
August 8, 2016
Sponsor
University Hospital, Montpellier
Collaborators
French Society of Emergency Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02860455
Brief Title
Role of Pulse Co-oximetry for Detecting Carbon Monoxide Poisoning in the Prehospital Emergency Medical Service Setting
Acronym
CO-OX
Official Title
Role of Pulse Co-oximetry in Prehospital Emergency Medical Service Management of Suspected Carbon Monoxide Poisoning : A Prospective Multicenter Study.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2012 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
French Society of Emergency Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carbon Monoxide Poisoning
Keywords
CO poisoning, CO-oximetry, Pulse oximetry, Carbon monoxide saturation (SpCO), Emergency Department, Sensitivity, Specificity
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
176 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SpCO and COHb measurement
Arm Type
Other
Arm Description
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
Intervention Type
Device
Intervention Name(s)
RAD57 measurement (SpCO)
Other Intervention Name(s)
Non invasive pulse CO-oximetry
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
CO-oximeter
Intervention Description
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 Measure Information:
Title
SpCO optimal threshold value for detection of CO poisoning
Description
prehospital medical management
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
SpCO level
Description
prehospital medical management
Time Frame
Baseline
Title
COHb Blood carboxyhemoglobin level
Description
prehospital medical management
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mustapha Sebbane, MD, PhD
Phone
0467337974
Email
m-sebbane@chu-montpellier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mustapha Sebbane, MD, PhD
Organizational Affiliation
Montpellier University hospital - Emergency department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montpellier University hospital - Emergency department
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mustapha Sebbane, MD, Ph.D
Phone
0467337974
Email
m-sebbane@chu-montpellier.fr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Role of Pulse Co-oximetry for Detecting Carbon Monoxide Poisoning in the Prehospital Emergency Medical Service Setting
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