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

1 oktober 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

65

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Frankrike
      • Nice, Frankrike, 06000
        • Rekrytering
        • CHU de Nice
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Diagnostisk
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Respiratory distress arm requiring a noninvasive ventilation
Diagnostiskt test: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
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.
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
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
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.

Samarbetspartners och utredare

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Sponsor

Centre Hospitalier Universitaire de Nice

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

28 september 2026

Primärt slutförande (Beräknad)

24 mars 2027

Avslutad studie (Beräknad)

24 mars 2027

Studieregistreringsdatum

Först inskickad

17 september 2026

Först inskickad som uppfyllde QC-kriterierna

17 september 2026

Första postat (Faktisk)

23 september 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

2 oktober 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 oktober 2026

Senast verifierad

1 oktober 2026

Mer information

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Nyckelord

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Andra studie-ID-nummer

  • 25-PP-13

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