跳至主要内容
临床试验/NCT05825534
NCT05825534已完成不适用

Pressure Opening With Electrical Impedance Tomography

Centre Hospitalier Universitaire, Amiens2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2023年9月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
6
试验地点
2
主要终点
prevalence of regional airway closure

研究概览

简要总结

Acute lung injury and ARDS (acute respiratory distress syndrome) are characterized by lung inhomogeneity, leading to a different distribution of the tidal volume (and pressure) within the lung. The quasi-static PV curve is a useful bedside tool to set mechanical ventilation, but it reflects a global behaviour of the lung. The electrical impedance tomography (EIT) is a non-invasive and radiation-free tool, monitoring dynamic changes in gas distribution. Images from EIT can be divided in several regions of interest, allowing to measure regional changes in compliance. The regional derived-EIT PV curve could provide valuable information on airway closure and AOP (airway opening pressure). Recent studies suggest that AOP measured by the ventilator seems to correspond to the AOP of the lowest injured lung. The investigators will perform one pressure-volume (PV) curve with a low-flow insufflation of 5 L/min starting from 0 cmH2O to a maximal airway pressure corresponding to the plateau pressure. During the low-flow insufflation, both ventilator and EIT-derived PV curves will be recorded. All PV curves will be analysed offline by the investigator to detect complete and regional airway closures, and measure AOPs.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

入选标准

  • Adult patients (≥18 years old).
  • Patients with PaO2/FiO2 ratio <300 mmHg.
  • Volume- or pressure-controlled ventilation.
  • Sedated, with or without infusion of neuromuscular blockage.
  • Patients in supine position

排除标准

  • Pneumothorax and bronchopleural fistula.
  • Severe hemodynamic instability (>30 % increase in vasopressors in the last 6 hours or norepinephrine > 0.5 µg/kg/min).
  • PaO2/FiO2 ratio < 80 mmHg.
  • Severe or very severe chronic obstructive pulmonary disease (COPD) according to the GOLD criteria (stage III: FEV1 30-50% predicted; stage IV: FEV1 < 30 % predicted).
  • Known or highly suspected elevated intracranial pressure (>18 mmHg).
  • Impossibility to correctly position the EIT belt (e.g., burns chest drainage, etc.).
  • Contraindications to EIT (e.g., implantable cardiac defibrillator, pacemaker, instable spinal lesions, etc.).
  • Clinical judgement of the attending physician.
  • Pregnant or breastfeeding woman
  • Patient under guardianship, curators or safeguard of justice

研究组 & 干预措施

EIT monitoring

Experimental

干预措施: EIT monitoring (Other)

结局指标

主要结局

prevalence of regional airway closure

时间窗: 1 year

Difference of global AOP values between EIT-derived method and the highest regional AOP

时间窗: 1 year

prevalence of complete airway closure

时间窗: 1 year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验