Expiratory Fow Assessment in ARDS Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 4
- 主要终点
- EFL at PEP 5 cmH2O
研究概览
简要总结
This study intended to assess the expiratory flow limitation (EFL) during tidal breath in patients intubated in intensive care unit (ICU) for moderate or severe acute respiratory distress syndrome (ARDS). EFL is defined as the lack of increase in expiratory flow in response to an increase in alveolar-to-atmospheric pressure gradient. It reflects airway closure. Early studies have been done using the Negative expiratory pressure (NEP) technique, which is no longer available. We proposed in present study a new method, which consists of diverting manually the expiratory flow to the atmosphere by-passing the expiratory valve. We aimed at assessing EFL at positive expiratory pressure (PEP) 5 cmH2O in semi-recumbent then in supine position together with measurement of trans-pulmonary pressure and regional lung ventilation. Higher PEP levels will be tested, namely 10, 15 and a trans-pulmonary PEP of 3 cmH2O, in semi-recumbent position.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •18 years or more in age
- •moderate to severe ARDS according to the Berlin definition : Intubated (or tracheotomized) and mechanically ventilated in the ICU
- •no pregnancy
- •informed consent from the next of kin
排除标准
- •Contra-indication to PEP > 5 cmH2O
- •extracorporeal membrane oxygenation (ECMO)
- •chest tube
- •mean arterial pressure < 65 mmHg
- •Contra-indication to oesophageal device
- •underlying disease fatal in less than one year
- •active therapy limitation
- •under guardian
- •refusal to participate
- •not affiliated to insurance regimen
- •speaking barrier of the next of kin
- •investigator not available
研究组 & 干预措施
Patients with EFL at PEP 5
Patients with EFL at PEP 5 at the time of inclusion either in supine or semi-recumbent position
干预措施: increase in positive end expiratory pressure (Other)
Patients with no EFL at PEP 5
Patients with no EFL at PEP 5 at the time of inclusion in both supine and semi-recumbent positions
干预措施: increase in positive end expiratory pressure (Other)
结局指标
主要结局
EFL at PEP 5 cmH2O
时间窗: at inclusion
A Fleish 2 pneumotachograph and a port to measure airway pressure are attached at the Y piece of the ventilator circuit and connected to a Biopac 150. At the end of inspiration the air is expelled to the atmosphere upstream the expiratory valve. The flow volume loop at baseline and that during the manoeuver are plotted and patients classified as EFL or not EFL (NFL). Measurements are taken in semi-recumbent then after 5 minutes in supine position.
次要结局
- Trans-pulmonary pressure at end expiratory at PEP 5(at inclusion)
- lung ventilation distribution at PEP 10 in EFL and NFL patients(15 minutes after PEP set to 10 cm H2O)
- lung ventilation distribution at PEP 15 in EFL and NFL patients(15 minutes after PEP set to 15 cm H2O)
- transcutaneous oxygen saturation (SpO2) at PEP 15 in EFL and NFL patients(15 minutes after PEP set to 15 cm H2O)
- Transcutaneous oxygen saturation (SpO2) at PEEP set to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O in EFL and NFL patients(15 minutes after PEEP set to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O)
- Trans-pulmonary pressure at end expiratory at PEP 10 in EFL and NFL patients(15 minutes after PEP set to 10 cm H2O)
- lung ventilation distribution at PEP set to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O in EFL and NFL patients(15 minutes after PEP set to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O)
- lung recruitment at PEEP 10 in EFL and NFL patients(15 minutes after PEEP set to 10 cm H2O)
- lung recruitment at PEEP set to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O in EFL and NFL patients in EFL and NFL patients(15 minutes after PEEP set to 15 cm H2O)
- Lung compliance at PEP 10 in EFL and NFL patients(15 minutes after PEP set to 10 cm H2O)
- Trans-pulmonary pressure at end expiratory at PEP to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O in EFL and NFL patients(15 minutes after PEP set to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O)
- lung recruitment at PEEP 15 in EFL and NFL patients(15 minutes after PEEP set to 15 cm H2O)
- Transcutaneous oxygen saturation (SpO2) at PEP 10 in EFL and NFL patients(15 minutes after PEP set to 10 cm H2O)
- Trans-pulmonary pressure at end expiratory at PEP 15 in EFL and NFL patients(15 minutes after PEP set to 15 cm H2O)
- Lung compliance at PEP 15 in EFL and NFL patients(15 minutes after PEP set to 15 cm H2O)
- Lung compliance at PEP to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O in EFL and NFL patients(15 minutes after PEP set to reach Trans-pulmonary pressure at end expiratory =+3 cmH2O)