Evaluation of CO Intoxication Rate, by CAPillary HbCO
COCAP
Evaluation of the Accuracy of Capillary Versus Venous CO Measurement in Subjects With Suspected Carbon Monoxide Poisoning: a Prospective, Multicenter, Diagnostic, Controlled Study.
2 other identifiers
observational
120
1 country
2
Brief 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).
Trial Health
Trial Health Score
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participants targeted
Target at P50-P75 for all trials
Started Feb 2025
2 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2024
CompletedFirst Posted
Study publicly available on registry
October 15, 2024
CompletedStudy Start
First participant enrolled
February 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 5, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 5, 2027
December 9, 2025
December 1, 2025
2 years
October 10, 2024
December 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
15 minutes
Secondary Outcomes (5)
Determine the diagnostic performance of capillary measurement
15 minutes
Assess the technical difficulties of different blood sampling processes (Measurement of the number of attempts and failure rate for samples)
15 minutes
Assess the technical difficulties of different blood sampling processes (Measurement of the time required to take each sample)
15 minutes
Analyse the technical difficulties associated with the analysis of the two samples (Time between sampling and HbCO result)
15 minutes
Analyse the technical difficulties associated with the analysis of the two samples (percentage of samples that cannot be analysed by the laboratory)
15 minutes
Study Arms (1)
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.)
Interventions
The process: blood drop sampling Technique: capillary sampling Frequency: Once Time: 5 minutes Sample collection volume: 1mL Total collection volume: 1 mL
Eligibility Criteria
The study population will consist of patients admitted to adult emergency departments with suspected carbon monoxide intoxication.
You may qualify if:
- 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.).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nantes University Hospitallead
- University Hospital, Angerscollaborator
Study Sites (2)
CHU d'Angers
Angers, Loire-Atlantique, 49100, France
Nantes University Hospital
Nantes, Loire-Atlantique, 44000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2024
First Posted
October 15, 2024
Study Start
February 5, 2025
Primary Completion (Estimated)
February 5, 2027
Study Completion (Estimated)
February 5, 2027
Last Updated
December 9, 2025
Record last verified: 2025-12