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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02860455|
Recruitment Status : Recruiting
First Posted : August 9, 2016
Last Update Posted : August 9, 2016
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||176 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
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.
- SpCO optimal threshold value for detection of CO poisoning [ Time Frame: Baseline ]prehospital medical management
- SpCO level [ Time Frame: Baseline ]prehospital medical management
- COHb Blood carboxyhemoglobin level [ Time Frame: Baseline ]prehospital medical management
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 ClinicalTrials.gov identifier (NCT number): NCT02860455
|Contact: Mustapha Sebbane, MD, PhDfirstname.lastname@example.org|
|Montpellier University hospital - Emergency department||Recruiting|
|Montpellier, France, 34295|
|Contact: Mustapha Sebbane, MD, Ph.D 0467337974 email@example.com|
|Principal Investigator:||Mustapha Sebbane, MD, PhD||Montpellier University hospital - Emergency department|