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Recruiting NCT06641752

Evaluation of CO Intoxication Rate, by CAPillary HbCO

— Observational Carbon Monoxide Intoxication

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood drop sampling.
Who it may be relevant to
Registry conditions: Carbon Monoxide Intoxication. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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).

Interventions

  • 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

Primary outcome measures

  • Determine the accuracy of capillary HbCO measurement (compared with venous or arterial HbCO) in patients with suspected CO poisoning. [Time frame: 15 minutes]
Secondary outcome measures (5)
  • Determine the diagnostic performance of capillary measurement [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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

France · 2 centers
  • CHU d'Angers — Angers
  • Nantes University Hospital — Nantes

Identifiers

NCT: NCT06641752 · RC24_0511 · 2024-A02162-45

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗