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NCT Number: NCT06641752

Evaluation of CO Intoxication Rate, by CAPillary HbCO

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).

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Key information

Conditions

Carbon Monoxide Intoxication Carbon Monoxide Poisoning Chemically-Induced Disorders Gas Poisoning Poisoning

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU d'Angers, Angers, Loire-Atlantique, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood drop sampling

Diagnostic Test

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. Determine the diagnostic performance of capillary measurement

    Time frame: 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.

  2. Assess the technical difficulties of different blood sampling processes (Measurement of the number of attempts and failure rate for samples)

    Time frame: 15 minutes

  3. Assess the technical difficulties of different blood sampling processes (Measurement of the time required to take each sample)

    Time frame: 15 minutes

  4. Analyse the technical difficulties associated with the analysis of the two samples (Time between sampling and HbCO result)

    Time frame: 15 minutes

  5. 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

Study contacts

Contact information is provided by the study sponsor or research team.

François JAVAUDIN, MD-Phd

CONTACT

[email protected]

33253482835

Jules Galy

CONTACT

[email protected]

0253482835

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Collaborators

  • University Hospital, Angers

Registry information

Official study title

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

Acronym: COCAP

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 15, 2024
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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