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RecruitingNCT06641752COCAPUpdated Dec 9, 2025

Evaluation of CO Intoxication Rate, by CAPillary HbCO

An observational study in Carbon Monoxide Intoxication, sponsored by Nantes University Hospital. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-09.

Sponsored by Nantes University Hospital · Observational

From the registry’s dates

  • Started Feb 2025; still recruiting 1 year 8 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
120
Ages
18 Years and older
Sex
All
01

Study summary

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).

02

Conditions studied

  • Carbon Monoxide Intoxication

Keywords

  • Intoxication
  • Carbon monoxyde
  • Carboxyhemoglobin
  • COHb
  • Carboxyhemoglobin capillary
03

In context

Carbon Monoxide Poisoning

42 studies on the registry are indexed under Carbon Monoxide Poisoning; 9 are open to participants now.

This study's planned enrollment of 120 is above the median of 104 across 25 observational studies indexed under Carbon Monoxide Poisoning.

Browse Carbon Monoxide Poisoning studies →

Lead sponsor

Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
120 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • Diagnostic testBlood drop sampling

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

06

What researchers measure

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

  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

07

Study locations

2 of 2 sites recruiting
  • CHU d'Angers
    Angers, Loire-Atlantique 49100, France
    Recruiting
  • Nantes University Hospital
    Nantes, Loire-Atlantique 44000, France
    • François JAVAUDIN, MD-PhD · Contact
    • François JAVAUDIN, MD-PhD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06641752
Lead sponsor
Nantes University Hospital
Collaborators
University Hospital, Angers
Responsible party
Sponsor
First posted
Oct 15, 2024
Start date
Feb 5, 2025
Primary completion
Feb 5, 2027 (estimated)
Completion
Feb 5, 2027 (estimated)
Last update
Dec 9, 2025

Study contacts

Jules Galy
Contact
bp-prom-regl@chu-nantes.fr
0253482835
François JAVAUDIN, MD-Phd
Contact
francois.javaudin@chu-nantes.fr
33253482835

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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