Comparison of Arterial and Capillary Blood Gas Analyses in Patients With Respiratory Distress Due to COPD or APE (GAZOCAP)
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.
Přehled studie
Postavení
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Nathalie Ducot, MD-PhD
- Telefonní číslo: +33 (0)4 92 03 32 42
- E-mail: ducot.n@chu-nice.fr
Studijní záloha kontaktů
- Jméno: Charlotte Monge
- Telefonní číslo: +33 (0)7 87 51 25 93
- E-mail: monge.c@chu-nice.fr
Studijní místa
-
-
-
Nice, Francie, 06000
- Nábor
- CHU de Nice
-
Kontakt:
- Nathalie Ducot, MD-PhD
- Telefonní číslo: +33 (0)4 92 03 32 42
- E-mail: ducot.n@chu-nice.fr
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Diagnostický
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Respiratory distress arm requiring a noninvasive ventilation
|
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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
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.
Časové okno: 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)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
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
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
|
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