Safety of Driving Pressure-guided Tidal Volume Setting in ARDS Patients-From the Perspective of EIT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- regional ventilation
研究概览
简要总结
A prospective physiologic study, in participants with COVID-19 related or non-COVID-19 related acute respiratory distress syndrome (ARDS) requiring mechanical ventilation less than 48 hours. The investigators assessed the effect of different tidal volume guided by different levels of driving pressure on ventilation inhomogeneity and ventilation/perfusion mismatch by electrical impedance tomography (EIT) in supine and/or prone position.
详细描述
Once enrolled, an EIT dedicated belt containing 16 electrodes was placed around the participant's chest at the fifth or sixth intercostal space and connected it to an EIT monitor (PulmoVista 500; Dräger Medical GmbH, Lübeck, Germany).
Data were collected in the enrolled day (Day 1),Day 3 and Day 7 including demographic and anthropometric data, a baseline arterial blood gas measurement, and ventilation parameters including type of supplemental oxygen, respiratory rate, fractional concentration of oxygen in inspired air (FiO2).
Volume control mode without spontaneous breathing, PEEP will be set according to best respiratory compliance method, and tidal volume (VT) will be set to reach three levels of driving pressure (High 14-15cmH2O, moderate 10-11 cmH2O, and low 7-8 cmH2O). Each level of VT was maintained 10 minutes in supine and/or prone position. In the last minutes of each phase，the participants received instructions of end expiratory occlusion lasting at least 10 seconds and, 1 seconds after the start, a bolus of 10 mL of 10% NaCl solution was injected via the central venous catheter. Clinical data and outcome will be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged ≥ 18 years old
- •admitted to intensive care unit with a moderate to severe ARDS
- •invasive mechanical ventilation
排除标准
- •contraindications for prone position ventilation
- •Past chronic respiratory diseases (long-term family oxygen therapy for chronic respiratory diseases such as pulmonary fibrosis or COPD)
- •New York Heart Association class above II
- •gave written or witnessed verbal informed consent.
- •Contraindications to the use of EIT (e.g., presence of pacemaker or chest surgical wounds dressing) or prone position (as decided by the attending physician)
- •Impending ECMO (on the basis of clinical judgment, including clinical and physiological parameters).
结局指标
主要结局
regional ventilation
时间窗: Day 1
regional ventilation using EIT
regional compliance using EIT
时间窗: Day 1
regional compliance using EIT
the number of regional lung perfusion
时间窗: Day 3
regional perfusion measuring by EIT
the number of regional lung ventilation
时间窗: Day 3
regional ventilation measuring by EIT
driving pressure
时间窗: Day 3
measurement as one index of respiratory compliance
regional perfusion
时间窗: Day 1
regional perfusion using EIT
Region-ventilation-delay
时间窗: Day 1
Region-ventilation-delay using EIT
the number of region-ventilation-delay (RVD)
时间窗: Day 3
the RVD measuring by EIT
次要结局
- Blood gas(Day 1)
- 28 day mortality(Day 28)
- The Global Inhomogeneity (GI) index(Day 7)
- Value of ventilation-perfusion (V/Q) mismatch(Day 7)
- Ventilation free day(Day 28)
研究者
Ling Liu
Director of Intensive Care Unit, Principal Investigator, Clinical Professor
Southeast University, China