Evaluation of CO Intoxication Rate, by CAPillary HbCO (COCAP)

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

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 Overview

• Status: Recruiting
• Conditions: Carbon Monoxide Intoxication
• Intervention / Treatment: Diagnostic test: Blood drop sampling

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Jules Galy; Phone Number: 0253482835; Email: bp-prom-regl@chu-nantes.fr
• Study Contact Backup: Name: François JAVAUDIN, MD-Phd; Phone Number: 33253482835; Email: francois.javaudin@chu-nantes.fr

Study Locations

• France
  • Loire-Atlantique
    • Angers, Loire-Atlantique, France, 49100
      • Recruiting
      • CHU d'Angers
      • Contact: Delphine Dr DOUILLET, MD-PhD; Phone Number: 332413536.7; Email: delphinedouillet@gmail.com
    • Nantes, Loire-Atlantique, France, 44000
      • Recruiting
      • Nantes University Hospital
      • Contact: François JAVAUDIN, MD-PhD
      • Principal Investigator: François JAVAUDIN, MD-PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study population; The study population must correspond to the research inclusion criteria: Adult patient admitted to the emergency department, presenting with 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.)	Diagnostic test: Blood drop sampling; The process: blood drop sampling Technique: capillary sampling Frequency: Once Time: 5 minutes Sample collection volume: 1mL Total collection volume: 1 mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	15 minutes
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

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Collaborators: University Hospital, Angers

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2025
• Primary Completion (Estimated): February 5, 2027
• Study Completion (Estimated): February 5, 2027

Study Registration Dates

• First Submitted: October 10, 2024
• First Submitted That Met QC Criteria: October 10, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Intoxication; Carboxyhemoglobin; Carbon monoxyde; COHb; Carboxyhemoglobin capillary
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Poisoning; Gas Poisoning; Carbon Monoxide Poisoning
• Other Study ID Numbers: RC24_0511; 2024-A02162-45 (Other Identifier: ANSM (IDRCB))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No