跳至主要内容
临床试验/NCT05717218
NCT05717218招募中不适用

Ultra-protective Ventilation Monitored by Electrical Impedance Tomography in Patients With Severe Acute Respiratory Distress Syndrome on Veno-venous ECMO

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年3月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
cumulated collapse and overdistention percentages for each tidal volume by impedancemetry method

研究概览

简要总结

For ECMO supported patients with severe ARDS (acute respiratory distress syndrome), usual care include use of "ultraprotective" mechanical ventilation with tidal volume and pressure reductions that might ultimately enhance lung protection of patients with ARDS. Although very low tidal might also cause pulmonary derecruitment. The aim of this study is to monitor effects of very low tidal volume on regression of overdistension and derecruitment using electrical impedance tomography.

Secondary aim is to describe the evolution of the optimal PEEP (Positive End Expiratory Pressure) during the decrease of the tidal volume

详细描述

Patients requiring venovenous ECMO support for severe ARDS will be monitored with electrical impedance tomography during introduction of "ultraprotective" mechanical ventilation.

Monitoring will start with pre-ECMO ventilator setting, then the tidal volume will be lowered step by step. Other parameters of the ventilator will be kept constant. Then, cumulated collapse and overdistention percentages will be estimated for each tidal volume. Optimal tidal volume will be defined by the lowest sum of alveolar overdistension and collapse.

Also, at the end of each step, PEEP titration will be performed to identify the optimal PEEP setting that combines the best alveolar recruitment with minimal overdistention. The aim is to determine whether the derecruitment induced by the decrease in tidal volume can be reduced by the application of PEP. Then, comparison of the different tidal volumes with application of ideal PEEP will be performed: measurement of the percentage of collapsed and overdistended areas by impedancemetry method between the different levels of tidal volume with application of ideal PEEP.

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

  • aged ≥ 18 years
  • patient with ARDS on venovenous (VV)-ECMO
  • Written informed consent
  • patient affiliated to a social security scheme

排除标准

  • Pregnancy
  • Adult patient subject to a legal protection measure (tutor, curator, etc.)
  • Patients with a pacemaker, automatic implantable cardioverter defibrillator,
  • contraindications to thoracic belt placement (e.g., thoracic or spinal cord trauma, recent thoracic surgery)
  • undrained pneumothorax, bronchopleural fistula
  • hemodynamic instability (i.e., use of intravenous fluids of more than 10 mL/kg or vasopressors 2 mg/h of norepinephrine or 0.5 mg/h of epinephrine)

结局指标

主要结局

cumulated collapse and overdistention percentages for each tidal volume by impedancemetry method

时间窗: One day

Estimating the "best" lung-compartment compliance, reflected by the number of functional lung units in that region, and current compliance for each pixel, the collapse and overdistention percentages per pixel will be compared for each tidal volume, with constant (pre-ECMO) PEEP.

次要结局

  • cumulated collapsed and overdistended for each tidal volume by impedancemetry method with application of optimal PEEP(One day)
  • Optimal PEEP by impedancemetry method at each tidal volume(One day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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