Carbon Monoxide IntoxicationCOCAPNCT06641752
Evaluation of CO Intoxication Rate, by CAPillary HbCO
An observational study of Carbon Monoxide Intoxication, run by Nantes University Hospital at 2 sites in France.
Trial summary
The main goal of COCAP is to compare COHb (carboxyhemoglobin) levels measured from venous or arterial samples with those measured from capillary samples in patients suspected of Carbon Monoxide intoxication.Patient participation in the study will be limited to capillary sampling (approx. 5-15 minutes). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carbon Monoxide Intoxication
- What is being tested?
- Blood drop sampling
- How many people
- 120 participants
- Where
- 2 sitesFrance
- Study dates
- 5 Feb 2025to 5 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: The study population will consist of patients admitted to adult emergency departments with suspected carbon monoxide intoxication.
Who may be able to join
- Adult patient admitted to emergency department
- Presenting one or more clinical signs (asthenia, headache, nausea, vomiting, loss of consciousness, etc.) and a history compatible with CO intoxication (collective symptoms, notion of smoke, activation of a detector, etc.).
Who cannot join
- Minors
- Patients under protective supervision (safeguard of justice, curatorship, guardianship)
- Incarcerated patients
- Pregnant or breast-feeding women
- Patients refusing to take part in the study
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
CHU d'Angers
Angers, Loire-Atlantique, 49100
Delphine Dr DOUILLET, MD-PhD, 332413536.7, delphinedouillet@gmail.com
- Recruiting
Nantes University Hospital
Nantes, Loire-Atlantique, 44000
François JAVAUDIN, MD-PhD
François JAVAUDIN, MD-PhD
About this study
Official title: Evaluation of the Accuracy of Capillary Versus Venous CO Measurement in Subjects With Suspected Carbon Monoxide Poisoning: a Prospective, Multicenter, Diagnostic, Controlled Study.
The main goal of COCAP is to compare COHb (carboxyhemoglobin) levels measured from venous or arterial samples with those measured from capillary samples in patients suspected of Carbon Monoxide intoxication.Patient participation in the study will be limited to capillary sampling (approx. 5-15 minutes).
- Conditions
- Carbon Monoxide Intoxication
- Being tested
- Blood drop sampling
- Keywords
- Intoxication, Carbon monoxyde, Carboxyhemoglobin, COHb, Carboxyhemoglobin capillary
- Medical subject headings
- Carbon Monoxide Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drop samplingDiagnostic test
The process: blood drop sampling Technique: capillary sampling Frequency: Once Time: 5 minutes Sample collection volume: 1mL Total collection volume: 1 mL
| Study group | Role | What they receive |
|---|---|---|
| Study population | The study population must correspond to the research inclusion criteria:
Adult patient admitted to the emergency department, presenting with one or more clinical signs (asthenia, headache, nausea, vomiting, loss of consciousness, etc.) and a history compatible with CO intoxication (collective symptoms, notion of smoke, activation of a detector, etc.) Receives: Diagnostic Test: Blood drop sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the accuracy of capillary HbCO measurement (compared with venous or arterial HbCO) in patients with suspected CO poisoning.
The main goal will be determined by the mean bias and limits of agreement between capillary and venous (or arterial) sampling (Bland-Altman analysis).
Measured: 15 minutes
Secondary outcomes (5)
Determine the diagnostic performance of capillary measurement
Determine the sensitivity, specificity, ROC curve, area under the ROC curve, positive and negative predictive values and likelihood ratios (positive and negative) of capillary measurement for the diagnosis of CO intoxication. The linear correlation coefficient between venous (or arterial) HbCO and capillary HbCO will also be calculated.
Measured: 15 minutes
Assess the technical difficulties of different blood sampling processes (Measurement of the number of attempts and failure rate for samples)
Measured: 15 minutes
Assess the technical difficulties of different blood sampling processes (Measurement of the time required to take each sample)
Measured: 15 minutes
Analyse the technical difficulties associated with the analysis of the two samples (Time between sampling and HbCO result)
Measured: 15 minutes
Analyse the technical difficulties associated with the analysis of the two samples (percentage of samples that cannot be analysed by the laboratory)
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start5 Feb 2025
- Primary completion5 Feb 2027 (estimated)
- Study completion5 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carbon Monoxide IntoxicationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Angers
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06641752
- Sponsor's protocol ID
- RC24_0511
- Other IDs
- 2024-A02162-45
- Acronym
- COCAP
- Status last verified
- Dec 2025
- First submitted
- 10 Oct 2024
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Accuracy of Capillary Versus Venous CO Measurement in Subjects With Suspected Carbon Monoxide Poisoning: a Prospective, Multicenter, Diagnostic, Controlled Study.
- ClinicalTrials.gov ID
- NCT06641752
- Acronym / sponsor ID
- COCAP / RC24_0511
- Conditions
- Carbon Monoxide Intoxication
- Keywords
- Intoxication, Carbon monoxyde, Carboxyhemoglobin, COHb, Carboxyhemoglobin capillary
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Angers
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- 5 Feb 2027 (estimated)
- Study completion
- 5 Feb 2027 (estimated)
- First posted
- 15 Oct 2024 (actual)
- 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 main goal of COCAP is to compare COHb (carboxyhemoglobin) levels measured from venous or arterial samples with those measured from capillary samples in patients suspected of Carbon Monoxide intoxication.Patient participation in the study will be limited to capillary sampling (approx. 5-15 minutes).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population | – | Diagnostic Test: Blood drop samplingThe study population must correspond to the research inclusion criteria: Adult patient admitted to the emergency department, presenting with one or more clinical signs (asthenia, headache, nausea, vomiting, loss of consciousness, etc.) and a history compatible with CO intoxication (collective symptoms, notion of smoke, activation of a detector, etc.) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of patients admitted to adult emergency departments with suspected carbon monoxide intoxication.
Key inclusion criteria (2 listed)
- Adult patient admitted to emergency department
- Presenting one or more clinical signs (asthenia, headache, nausea, vomiting, loss of consciousness, etc.) and a history compatible with CO intoxication (collective symptoms, notion of smoke, activation of a detector, etc.).
Key exclusion criteria (5 listed)
- Minors
- Patients under protective supervision (safeguard of justice, curatorship, guardianship)
- Incarcerated patients
- Pregnant or breast-feeding women
- Patients refusing to take part in the study
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 |
|---|---|---|
| Blood drop samplingThe process: blood drop sampling Technique: capillary sampling Frequency: Once Time: 5 minutes Sample collection volume: 1mL Total collection volume: 1 mL | Diagnostic test | Study population |
Primary outcome
Determine the accuracy of capillary HbCO measurement (compared with venous or arterial HbCO) in patients with suspected CO poisoning.
Time frame: 15 minutes
The main goal will be determined by the mean bias and limits of agreement between capillary and venous (or arterial) sampling (Bland-Altman analysis).
5 secondary outcomes
Determine the diagnostic performance of capillary measurement
Time frame: 15 minutes
Assess the technical difficulties of different blood sampling processes (Measurement of the number of attempts and failure rate for samples)
Time frame: 15 minutes
Assess the technical difficulties of different blood sampling processes (Measurement of the time required to take each sample)
Time frame: 15 minutes
Analyse the technical difficulties associated with the analysis of the two samples (Time between sampling and HbCO result)
Time frame: 15 minutes
Analyse the technical difficulties associated with the analysis of the two samples (percentage of samples that cannot be analysed by the laboratory)
Time frame: 15 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carbon Monoxide Intoxication, run by Nantes University Hospital at 2 sites 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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jules Galy (0253482835, bp-prom-regl@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the accuracy of capillary HbCO measurement (compared with venous or arterial HbCO) in patients with suspected CO poisoning. (time frame: 15 minutes). 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 Dec 2025.