Evaluation of CO Intoxication Rate, by CAPillary HbCO

Not yet recruiting

• Conditions: Carbon Monoxide Intoxication

• Registration Number: NCT06641752
• Lead Sponsor: Nantes University Hospital

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-10
• Study First Submitted QC: 2024-10-10
• Last Update Submitted: 2024-10-10
• Study First Posted: 2024-10-15
• Last Update Posted: 2024-10-15
• Study Start: 2025-01-01
• Primary Completion: 2027-01-01
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 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.).

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine the accuracy of capillary HbCO measurement (compared with venous or arterial HbCO) in patients with suspected CO poisoning.	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).

Secondary Outcome Measures

Name	Time	Method
Determine the diagnostic performance of capillary measurement	15 minutes	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.
Assess the technical difficulties of different blood sampling processes.	15 minutes	Measure number of attempts and failure rate for capillary and venous (or arterial) blood sampling. Measure the time required to perform each sampling procedure (venous or arterial and capillary).
Analyse the technical difficulties associated with the analysis of the two samples.	15 minutes	Time between sampling and HbCO result, rate of samples that cannot be analyzed by the laboratory

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, Loire-Atlantique, France