Evaluation of CO Intoxication Rate, by CAPillary HbCO

Nantes University Hospital120 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

Carbon Monoxide Intoxication

Interventions

Blood drop samplingDIAGNOSTIC_TEST

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

CHU d'Angers

Angers, Loire-Atlantique, France

RECRUITING

Nantes University Hospital

Nantes, Loire-Atlantique, France

RECRUITING

Outcomes

Primary Outcomes

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

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

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

Time frame: 15 minutes

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

Time frame: 15 minutes

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

Time frame: 15 minutes

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

Central Contacts

Jules Galy

CONTACT

0253482835 bp-prom-regl@chu-nantes.fr

François JAVAUDIN, MD-Phd

CONTACT

33253482835 francois.javaudin@chu-nantes.fr

Data from ClinicalTrials.gov

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