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

Not Applicable

• Conditions: Carbon Monoxide Poisoning
• Interventions: Device: RAD57 measurement (SpCO); Device: CO-oximeter

• Registration Number: NCT02860455
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2012-02
• Status Verified: 2016-08
• Study First Submitted: 2016-08-02
• Study First Submitted QC: 2016-08-08
• Last Update Submitted: 2016-08-08
• Study First Posted: 2016-08-09
• Last Update Posted: 2016-08-09
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SpCO and COHb measurement	RAD57 measurement (SpCO)	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
SpCO and COHb measurement	CO-oximeter	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

Primary Outcome Measures

Name	Time	Method
SpCO optimal threshold value for detection of CO poisoning	Baseline	prehospital medical management

Secondary Outcome Measures

Name	Time	Method
COHb Blood carboxyhemoglobin level	Baseline	prehospital medical management
SpCO level	Baseline	prehospital medical management

Trial Locations

Locations (1)

Montpellier University hospital - Emergency department; 🇫🇷 Montpellier, France