About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Capillary blood gas analysis
Diagnostic testThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Agreement between arterial and capillary pCO₂ measurements, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement
Secondary outcomes
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
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.
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.
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.
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.
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
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.
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
Sponsors and contacts
Click on the lead sponsor to view all of their trials.