NCT02860455

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
176

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 9, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

August 9, 2016

Status Verified

August 1, 2016

Enrollment Period

5.8 years

First QC Date

August 2, 2016

Last Update Submit

August 8, 2016

Conditions

Carbon Monoxide Poisoning

Keywords

CO poisoningCO-oximetryPulse oximetryCarbon monoxide saturation (SpCO)Emergency DepartmentSensitivitySpecificity

Outcome Measures

Primary Outcomes (1)

  • SpCO optimal threshold value for detection of CO poisoning

    prehospital medical management

    Baseline

Secondary Outcomes (2)

  • SpCO level

    Baseline

  • COHb Blood carboxyhemoglobin level

    Baseline

Study Arms (1)

SpCO and COHb measurement

OTHER

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)Device: CO-oximeter

Interventions

RAD57 measurement (SpCO)DEVICE

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.

Also known as: Non invasive pulse CO-oximetry
SpCO and COHb measurement
CO-oximeterDEVICE

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 and COHb measurement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patient for whom venous blood sampling cannot be obtained prehospitally
  • Patient for whom SpCo measurement cannot be performed prehospitally (cardiac arrest, peripheral vasoconstriction)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montpellier University hospital - Emergency department

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Carbon Monoxide PoisoningEmergenciesHypersensitivity

Condition Hierarchy (Ancestors)

Gas PoisoningPoisoningChemically-Induced DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsImmune System Diseases

Study Officials

  • Mustapha Sebbane, MD, PhD

    Montpellier University hospital - Emergency department

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mustapha Sebbane, MD, PhD

CONTACT

0467337974m-sebbane@chu-montpellier.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2016

First Posted

August 9, 2016

Study Start

February 1, 2012

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

August 9, 2016

Record last verified: 2016-08

Locations

FR(1)