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Comparison of Arterial and Capillary Blood Gas Analyses in Patients With Respiratory Distress Due to COPD or APE (GAZOCAP)

1 octobre 2026 mis à jour par: Centre Hospitalier Universitaire de Nice

The assessment of gas exchange is crucial for the management of patients suffering from respiratory distress due to an exacerbation of chronic obstructive pulmonary disease (COPD) or cardiogenic acute pulmonary edema (APE). These measurements are used by physicians to determine the need for noninvasive ventilation (NIV) as well as to evaluate its effectiveness and to decide whether to continue the treatment.

Arterial blood gas analysis is currently the gold standard for the measurement of these gas exchanges, though invasive, painful and risky (failure risks and possible local complications). Capillary blood gas analysis, which consists in collecting a blood drop from the ear or the finger by capillarity after punction, could represent a less invasive alternative. However, data comparing the performances of arterial and capillary blood gas analysis in the context of respiratory distress requiring a NIV remain limited.

This study is based on the hypothesis that capillary blood gas analysis can perform as well as arterial blood gas analysis. It is aimed at comparing values obtained from arterial and capillary blood gas analyses from patients with respiratory distress and requiring a NIV due to an exacerbation of COPD or cardiogenic APE.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

65

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Nathalie Ducot, MD-PhD
  • Numéro de téléphone: +33 (0)4 92 03 32 42
  • E-mail: ducot.n@chu-nice.fr

Sauvegarde des contacts de l'étude

  • Nom: Charlotte Monge
  • Numéro de téléphone: +33 (0)7 87 51 25 93
  • E-mail: monge.c@chu-nice.fr

Lieux d'étude

  • France
      • Nice, France, 06000
        • Recrutement
        • CHU de Nice
        • Contact:
          • Nathalie Ducot, MD-PhD
          • Numéro de téléphone: +33 (0)4 92 03 32 42
          • E-mail: ducot.n@chu-nice.fr

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Patients older than 18 years old
  • Patients admitted in the emergency care unit with an exacerbation of COPD or a cardiogenic APE requiring a non-invasive ventilation (i.e. for COPD patients pH< 7.35, for APE patients: PCO2 > 45 mmHg)
  • Patients affiliated to a social security system

Exclusion Criteria:

  • Patients for which a non-invasive ventilation was initiated upon pre-hospital care
  • Contraindication for non-invasive ventilation
  • Patients for which non-invasive ventilation is not indicated
  • Patients for which capillary or arterial blood gas analyses are impossible
  • Adults subject to legal guardianship (guardianship, conservatorship)
  • Pregnant women
  • Patients with a congenital heart disease

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Diagnostique
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Respiratory distress arm requiring a noninvasive ventilation
Test diagnostique: Capillary blood gas analysis

The intervention consists in carrying out arterial, veinous and capillary blood gas analyses before submitting the patient to noninvasive ventilation (5 minutes will separate each sampling). Data from these samplings will be recorded. 1 hour after the implementation of the noninvasive ventilation, patients will once again undergo arterial, veinous and capillary samplings for blood gas analyses. Respiratory parameters will be recorded as well at the onset of the noninvasive ventilation and one hour after its start.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Agreement between carbon dioxide pressure (PCO2) values obtained from capillary and arterial blood gas analyses in patients requiring a non-invasive ventilation due to an exacerbation of COPD or a cardiogenic APE.
Délai: Baseline (once the patient arrives at the emergency care unit and is included in the study)

Agreement between arterial and capillary pCO₂ measurements, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement
Baseline (once the patient arrives at the emergency care unit and is included in the study)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Agreement between pH values obtained from capillary and arterial blood gas analyses in patients requiring a non-invasive ventilation due to an exacerbation of COPD or a cardiogenic APE
Délai: Baseline (once the patient arrives at the emergency care unit and is included in the study)

Agreement between pH values obtained from capillary and arterial blood gas analyses, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement.
Baseline (once the patient arrives at the emergency care unit and is included in the study)
Agreement between bicarbonate concentration values obtained from capillary and arterial blood gas analyses in patients requiring a non-invasive ventilation due to an exacerbation of COPD or a cardiogenic APE.
Délai: Baseline (once the patient arrives at the emergency care unit and is included in the study)

Agreement between bicarbonate concentration values obtained from capillary and arterial blood gas analyses, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement.
Baseline (once the patient arrives at the emergency care unit and is included in the study)
Agreement between base concentration values obtained from capillary and arterial blood gas analyses in patients requiring a non-invasive ventilation due to an exacerbation of COPD or a cardiogenic APE.
Délai: Baseline (once the patient arrives at the emergency care unit and is included in the study)

Agreement between base concentration values obtained from capillary and arterial blood gas analyses, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement
Baseline (once the patient arrives at the emergency care unit and is included in the study)
Agreement between PCO2 values obtained from capillary and arterial blood gas analyses in patients with an exacerbation of COPD or a cardiogenic APE one hour after initiation of non-invasive ventilation.
Délai: One hour after initiation of non-invasive ventilation.

Agreement between PCO2 values obtained from capillary and arterial blood gas analyses, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement
One hour after initiation of non-invasive ventilation.
Agreement between pH values obtained from capillary and arterial blood gas analyses in patients with an exacerbation of COPD or a cardiogenic APE one hour after initiation of non-invasive ventilation.
Délai: One hour after initiation of non-invasive ventilation.

Agreement between pH values obtained from capillary and arterial blood gas analyses, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement.
One hour after initiation of non-invasive ventilation.
Agreement between bicarbonate concentration values obtained from capillary and arterial blood gas analyses in patients with an exacerbation of COPD or a cardiogenic APE one hour after initiation of non-invasive ventilation.
Délai: One hour after initiation of non-invasive ventilation.

Agreement between bicarbonate concentration values obtained from capillary and arterial blood gas analyses, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement
One hour after initiation of non-invasive ventilation.
Agreement between base concentration values obtained from capillary and arterial blood gas analyses in patients with an exacerbation of COPD or a cardiogenic APE one hour after initiation of non-invasive ventilation.
Délai: One hour after initiation of non-invasive ventilation.

Agreement between base concentration values obtained from capillary and arterial blood gas analyses, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement.
One hour after initiation of non-invasive ventilation.
Agreement between PCO2 values obtained from veinous and arterial blood gas analyses in patients requiring a non-invasive ventilation due to an exacerbation of COPD or a cardiogenic APE.
Délai: Baseline (once the patient arrives at the emergency care unit and is included in the study).

Agreement between PCO2 values obtained from veinous and arterial blood gas analyses, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement
Baseline (once the patient arrives at the emergency care unit and is included in the study).
Agreement between pH values obtained from veinous and arterial blood gas analyses in patients requiring a non-invasive ventilation due to an exacerbation of COPD or a cardiogenic APE.
Délai: Baseline (once the patient arrives at the emergency care unit and is included in the study).

Agreement between pH values obtained from veinous and arterial blood gas analyses, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement.
Baseline (once the patient arrives at the emergency care unit and is included in the study).
Agreement between bicarbonate concentration values obtained from veinous and arterial blood gas analyses in patients requiring a non-invasive ventilation due to an exacerbation of COPD or a cardiogenic APE.
Délai: Baseline (once the patient arrives at the emergency care unit and is included in the study).

Agreement between bicarbonate concentration values obtained from veinous and arterial blood gas analyses, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement
Baseline (once the patient arrives at the emergency care unit and is included in the study).
Agreement between base concentration values obtained from veinous and arterial blood gas analyses in patients requiring a non-invasive ventilation due to an exacerbation of COPD or a cardiogenic APE.
Délai: Baseline (once the patient arrives at the emergency care unit and is included in the study).

Agreement between base concentration values obtained from veinous and arterial blood gas analyses, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement
Baseline (once the patient arrives at the emergency care unit and is included in the study).
Agreement between PCO2 values obtained from veinous and arterial blood gas analyses in patients with an exacerbation of COPD or a cardiogenic APE one hour after initiation of non-invasive ventilation.
Délai: One hour after initiation of non-invasive ventilation.

Agreement between PCO2 values obtained from veinous and arterial blood gas analyses, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement
One hour after initiation of non-invasive ventilation.
Agreement between pH values obtained from veinous and arterial blood gas analyses in patients with an exacerbation of COPD or a cardiogenic APE one hour after initiation of non-invasive ventilation.
Délai: One hour after initiation of non-invasive ventilation.

Agreement between pH values obtained from veinous and arterial blood gas analyses, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement
One hour after initiation of non-invasive ventilation.
Agreement between bicarbonate concentration values obtained from veinous and arterial blood gas analyses in patients with an exacerbation of COPD or a cardiogenic APE one hour after initiation of non-invasive ventilation.
Délai: One hour after initiation of non-invasive ventilation.

Agreement between Bicarbonate concentration values obtained from veinous and arterial blood gas analyses, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement
One hour after initiation of non-invasive ventilation.
Agreement between base concentration values obtained from veinous and arterial blood gas analyses in patients with an exacerbation of COPD or a cardiogenic APE one hour after initiation of non-invasive ventilation.
Délai: One hour after initiation of non-invasive ventilation.

Agreement between base concentration values obtained from veinous and arterial blood gas analyses, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement
One hour after initiation of non-invasive ventilation.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Centre Hospitalier Universitaire de Nice

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

28 septembre 2026

Achèvement primaire (Estimé)

24 mars 2027

Achèvement de l'étude (Estimé)

24 mars 2027

Dates d'inscription aux études

Première soumission

17 septembre 2026

Première soumission répondant aux critères de contrôle qualité

17 septembre 2026

Première publication (Réel)

23 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

2 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 octobre 2026

Dernière vérification

1 octobre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 25-PP-13

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INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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