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Evaluation of CO Intoxication Rate, by CAPillary HbCO

Evaluation of the Accuracy of Capillary Versus Venous CO Measurement in Subjects With Suspected Carbon Monoxide Poisoning: a Prospective, Multicenter, Diagnostic, Controlled Study.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06641752
Acronym
COCAP
Enrollment
120
Registered
2024-10-15
Start date
2025-02-05
Completion date
2027-02-05
Last updated
2025-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carbon Monoxide Intoxication

Keywords

Intoxication, Carbon monoxyde, Carboxyhemoglobin, COHb, Carboxyhemoglobin capillary

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).

Interventions

DIAGNOSTIC_TESTBlood drop sampling

The process: blood drop sampling Technique: capillary sampling Frequency: Once Time: 5 minutes Sample collection volume: 1mL Total collection volume: 1 mL

Sponsors

University Hospital, Angers
CollaboratorOTHER_GOV
Nantes University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Determine the accuracy of capillary HbCO measurement (compared with venous or arterial HbCO) in patients with suspected CO poisoning.15 minutesThe main goal will be determined by the mean bias and limits of agreement between capillary and venous (or arterial) sampling (Bland-Altman analysis).

Secondary

MeasureTime frameDescription
Determine the diagnostic performance of capillary measurement15 minutesDetermine 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 (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

Countries

France

Contacts

Primary ContactJules Galy
bp-prom-regl@chu-nantes.fr0253482835
Backup ContactFrançois JAVAUDIN, MD-Phd
francois.javaudin@chu-nantes.fr33253482835

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026