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

Carbon Monoxide Poisoning Clinical Trial

— CO-OX  

Official title:

Role of Pulse Co-oximetry in Prehospital Emergency Medical Service Management of Suspected Carbon Monoxide Poisoning : A Prospective Multicenter Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02860455
• Other study ID #: 8869
• Status: Recruiting
• Phase: N/A
• First received: August 2, 2016
• Last updated: August 8, 2016
• Start date: February 2012
• Est. completion date: December 2017

Study information

• Verified date: August 2016
• Source: University Hospital, Montpellier
• Contact: Mustapha Sebbane, MD, PhD
• Phone: 0467337974
• Email: m-sebbane[@]chu-montpellier.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 176
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carbon Monoxide Poisoning
• Emergencies
• Poisoning

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Montpellier University hospital - Emergency department	Montpellier

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	french society for emergency medicine

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SpCO optimal threshold value for detection of CO poisoning	prehospital medical management	Baseline	No
Secondary	SpCO level	prehospital medical management	Baseline	No
Secondary	COHb Blood carboxyhemoglobin level	prehospital medical management	Baseline	No