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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02860455
Other study ID # 8869
Secondary ID
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


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
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