Evaluation of Respiratory Mechanics and Lung Recruitment in Patients With SARS-CoV-2 Associated Acute Respiratory Distress Syndrome
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Recruitment-to Inflation ratio (R/I ratio)
研究概览
简要总结
The aim of this observationnal study is to describe respiratory mechanics and lung recruitement in patients with SARS-CoV-2 Associated Acute Respiratory Distress Syndrome who underwent invasive ventilation on endotracheal tube, admitted to the medical ICU of Angers university hospital . Statics measurements of respiratory system compliance were performed at 2 differents levels of PEEP (15 cmH2O and 5 cmH2O). The recruited volume is computed as the difference between the volume expired from PEEP 15 to 5 cmH2O and the volume predicted by compliance at PEEP 5 cmH2O . The recruitment-to-Inflation (R/I) ratio (i.e. the ratio between the recruited lung compliance and CRS at PEEP 5 cmH2O) is used to assess lung recruitability. A R/I ratio value higher than or equal to 0.5 was used to define highly recruiter patients.
详细描述
The investigators perform an observational prospective study in patients admitted to medical ICU in Angers University hospital with a confirmed COVID 19 pneumonia and who require invasive ventilation on endotracheal tube. Participants receive initially deep sedation and neuromuscular blockers for 24 hours and are ventilated in volume-controlled mode with a tidal volume of 6 mL/kg of predicted body weight, a constant inspiratory flow of 60 L/minute and a respiratory rate adjusted to maintain pH above 7.35 when possible. A PEEP decremental trial from 15 to 5 cmH2O was performed (15 minutes by step).
Esophageal pressure monitoring and electrical impedance tomography (EIT) are collected if available. Arterial blood gases and respiratory mechanics are measured at the end of each step.
The recruitment-to-Inflation (R/I) ratio (i.e. the ratio between the recruited lung compliance and CRS at PEEP 5 cmH2O) is used to assess lung recruitability. A R/I ratio value higher than or equal to 0.5 is used to define highly recruiter patients.
By the end of the recording time, a low-flow (5 L/min) inflation from PEEP 5 cmH2O (tidal volume = 6ml/kg PBW) is then performed after a prolonged expiration to identify a potential airway closure and the corresponding airway opening pressure (AOP).
Investigators perform these measurements at day 1, day 5 and day 10 from ICU admission if participants still require controlled ventilation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •ARDS criteria according to Berlin classification criteria
- •Invasive mechanical ventilation on endotracheal tube
- •SARS Cov-2 infection
排除标准
- •pneumothorax
结局指标
主要结局
Recruitment-to Inflation ratio (R/I ratio)
时间窗: Day 10
no unit
次要结局
- Plateau pressure (cm H2O)(Day 10)
- Lung volume recruited (VRec)(Day 10)
- Oesophagal pressure (cm H2O)(Day 10)
- urine output (mL)(day 10)
- Mean arterial pressure (mmHg)(day 10)
- Airway pening pressure (cm H2O)(day 10)
- PaO2/FiO2 (mmHg)(Day 10)
- weight (Kg)(Day 10)
- serum creatinine (Umo/L)(day 10)
- PEEP total (cm H2O)(Day 10)
- PEP Set (cm H2O)(Day 10)
- Peak Pressure (cm H2O)(Day 10)
- Height (cm)(Day 1)
- Expired volume in PEEP setted at 15 cmH2O (mL)(Day 10)
- Expired volume in PEEP setted at 5 cmH2O (mL)(Day 10)