Carbon Monoxide PoisoningCO-OXNCT02860455
Role of Pulse Co-oximetry for Detecting Carbon Monoxide Poisoning in the Prehospital Emergency Medical Service Setting
A study testing RAD57 measurement (SpCO) and CO-oximeter in people with Carbon Monoxide Poisoning, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carbon Monoxide Poisoning
- What is being tested?
- RAD57 measurement (SpCO) and CO-oximeter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2012to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient for whom venous blood sampling cannot be obtained prehospitally
- Patient for whom SpCo measurement cannot be performed prehospitally (cardiac arrest, peripheral vasoconstriction)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Montpellier University hospital - Emergency department
Montpellier, 34295
Mustapha Sebbane, MD, Ph.D, 0467337974, m-sebbane@chu-montpellier.fr
About this study
Official title: 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.
Read the 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.
- Conditions
- Carbon Monoxide Poisoning
- Being tested
- RAD57 measurement (SpCO), CO-oximeter
- Keywords
- CO poisoning, CO-oximetry, Pulse oximetry, Carbon monoxide saturation (SpCO), Emergency Department, Sensitivity, Specificity
- Medical subject headings
- Carbon Monoxide Poisoning, Emergencies, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAD57 measurement (SpCO)Device
Also called Non invasive pulse CO-oximetry
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-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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: RAD57 measurement (SpCO); Device: CO-oximeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
SpCO optimal threshold value for detection of CO poisoning
prehospital medical management
Measured: Baseline
Secondary outcomes (2)
SpCO level
prehospital medical management
Measured: Baseline
COHb Blood carboxyhemoglobin level
prehospital medical management
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study startFeb 2012
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carbon Monoxide PoisoningStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- French Society of Emergency Medicine
- Responsible party
- Sponsor
- Investigators
- Mustapha Sebbane, MD, PhD, Principal investigator, Montpellier University hospital - Emergency department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02860455
- Sponsor's protocol ID
- 8869
- Acronym
- CO-OX
- Status last verified
- Aug 2016
- First submitted
- 2 Aug 2016
- Last updated
- 9 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Pulse Co-oximetry in Prehospital Emergency Medical Service Management of Suspected Carbon Monoxide Poisoning : A Prospective Multicenter Study.
- ClinicalTrials.gov ID
- NCT02860455
- Acronym / sponsor ID
- CO-OX / 8869
- Conditions
- Carbon Monoxide Poisoning
- Keywords
- CO poisoning, CO-oximetry, Pulse oximetry, Carbon monoxide saturation (SpCO), Emergency Department, Sensitivity, Specificity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- French Society of Emergency Medicine
- Study start
- Feb 2012
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 9 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SpCO and COHb measurement | Other | Device: RAD57 measurement (SpCO), Device: CO-oximeterSpCO 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patient for whom venous blood sampling cannot be obtained prehospitally
- Patient for whom SpCo measurement cannot be performed prehospitally (cardiac arrest, peripheral vasoconstriction)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RAD57 measurement (SpCO)Also: Non invasive pulse CO-oximetrySpCO 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. | Device | SpCO and COHb measurement |
| CO-oximeterCOHb 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. | Device | SpCO and COHb measurement |
Primary outcome
SpCO optimal threshold value for detection of CO poisoning
Time frame: Baseline
prehospital medical management
2 secondary outcomes
SpCO level
Time frame: Baseline
COHb Blood carboxyhemoglobin level
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mustapha Sebbane, MD, PhD principal investigator
Montpellier University hospital - Emergency department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RAD57 measurement (SpCO) and CO-oximeter in people with Carbon Monoxide Poisoning, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mustapha Sebbane, MD, PhD (0467337974, m-sebbane@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SpCO optimal threshold value for detection of CO poisoning (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2016.