Comparison of Arterial and Capillary Blood Gas Analyses in Patients With Respiratory Distress Due to COPD or APE
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 65
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Respiratory distress arm requiring a noninvasive ventilation
干预措施: Capillary blood gas analysis (Diagnostic Test)
结局指标
主要结局
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.
时间窗: 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
次要结局
- 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(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.(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.(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.(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.(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.(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.(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.(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.(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.(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.(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.(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.(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.(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.(One hour after initiation of non-invasive ventilation.)