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Evaluation of CO Intoxication Rate, by CAPillary HbCO

ConditionCarbon Monoxide Intoxication
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNantes University Hospital

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.).

Disqualifiers

Minors

Patients under protective supervision (safeguard of justice, curatorship, guardianship)

Incarcerated patients

Pregnant or breast-feeding women

Trial population

The study population will consist of patients admitted to adult emergency departments with suspected carbon monoxide intoxication.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: Study population1 intervention

Trial outcomes

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).

Time frame
15 minutes

Secondary outcomes

1

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.

Time frame
15 minutes
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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nantes University Hospital

Lead sponsor

University Hospital, Angers

Collaborator

Source ClinicalTrials.gov
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