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

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

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.

Study Overview

• Status: Unknown
• Conditions: Carbon Monoxide Poisoning
• Intervention / Treatment: Device: RAD57 measurement (SpCO); Device: CO-oximeter

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 Type: Interventional
• Enrollment (Anticipated): 176
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • Montpellier University hospital - Emergency department
    • Contact: Mustapha Sebbane, MD, Ph.D; Phone Number: 0467337974; Email: m-sebbane@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SpCO optimal threshold value for detection of CO poisoning	prehospital medical management	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SpCO level	prehospital medical management	Baseline
COHb Blood carboxyhemoglobin level	prehospital medical management	Baseline

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: French Society of Emergency Medicine
• Investigators: Principal Investigator: Mustapha Sebbane, MD, PhD, Montpellier University hospital - Emergency department

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: August 2, 2016
• First Submitted That Met QC Criteria: August 8, 2016
• First Posted (Estimate): August 9, 2016

Study Record Updates

• Last Update Posted (Estimate): August 9, 2016
• Last Update Submitted That Met QC Criteria: August 8, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Emergency Department; Sensitivity; Specificity; Pulse oximetry; CO poisoning; CO-oximetry; Carbon monoxide saturation (SpCO)
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Disease Attributes; Gas Poisoning; Emergencies; Poisoning; Carbon Monoxide Poisoning
• Other Study ID Numbers: 8869

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided