跳至主要内容
临床试验/NCT04925518
NCT04925518已完成不适用

Closed Loop Mechanical Ventilation Coupled to Extracorporeal Membrane Oxygenation Support in Therapy Refractory Acute Respiratory Distress Syndrome and Cardiogenic Shock

University of Zurich0 个研究点目标入组 62 人开始时间: 2016年3月6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
62
主要终点
Change in Tidal Volumes

研究概览

简要总结

Mechanical ventilation and ECMO are both technologies interacting on gas exchange. Nevertheless, besides a consensus paper, no evidence-based guidelines regarding protective lung ventilation on ECMO exist to date. Mechanical Ventilation with Intellivent-ASV, an algorithm driven, closed loop system, provides an opportunity to standardize ventilation on ECMO.

We propose and validate lung protective ventilation with a closed loop ventilation mode in patients with ECMO.

详细描述

In critically ill patients admitted to the intensive care unit due to either acute respiratory failure or circulatory collapse, mechanical ventilation in combination with either extra-corporal lung assist (VV ECMO) or cardiac assist (VA ECMO) is increasingly used. Both mechanical ventilation and ECMO contribute to the control of gas exchange hence need to be adjusted accordingly.

As an assist device like a VV ECMO or a VA ECMO the control the gas exchange needs to be adjusted via sweep gas flow (ventilation), fraction of oxygen in the sweep gas (oxygenation, FsO2) and blood flow over the extracorporeal device. The combination of adaptive ventilation with ECMO is a novel concept allowing the control of oxygenation and ventilation by the adjustment of the ECMO device only.

Adaptive lung ventilation is a category of ventilation modes, which allow the control of oxygenation and ventilation with a closed loop. Using this type of ventilation modes one can control the gas exchange automatically. In terms of CO2-management they use a target minute volume to control end-tidal CO2 and adjust depending on the amount of spontaneously triggered breaths the respiratory rate and the inspiratory pressure support or solely the pressure support. In terms of O2-management according to the peripheral O2 saturation target the PEEP (lung recruitment) and the fraction of inspired oxygen (FiO2) will be set. Both of these controllers depend on an accurate measurement of either end-tidal CO2 and peripheral O2 saturation, respectively.

There exist two recommendations how to ventilate patients with ARDS on an ECMO. First and foremost, the general guidelines of the Extracorporeal Life Support Organization (ELSO) suggest for adults to target a FiO2 of less than 0.3 with a PEEP of 5 to 15 cmH2O and a plateau pressure of less than 25 cm H2O with a respiratory rate of 5 per minute. Whereas Richard et al. in their consensus conference report from 2014 suggest to minimize plateau pressure and PEEP not being specific in terms of numbers. Both guidelines have the goal of keeping the lung at rest concerning patients with ARDS. There are no specific suggestions on ventilation management in patients with heart failure on ECMO. Whether the lung has to be kept open (recruited and less prone to atelectrauma) or kept at rest (less prone to overdistension, either volu- or barotrauma) is at the moment unclear.

Concerning mechanical ventilation settings in patients with ARDS Serpa Neto and colleagues published in 2016 a meta-analysis of nine studies, which included around 550 patients receiving ECMO for refractory hypoxemia. They showed that in these patients driving pressure was associated with in-hospital survival (survivors had a driving pressure of 16.9 cmH2O and non-survivors of 19.4, p 0.004, adjusted HR 1.06 with a 95% CI of 1.03 - 1.10). This is consistent with the study of Amato et al where they showed a reduction of the multivariate relative risk of in-hospital mortality in patients with ARDS - without ECMO - with a driving pressure of less than 15 cmH2O.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Treatment
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

  • •Mechanical Ventilation and ECMO
  • •Refractory Acute Respiratory Distress Syndrome or Refractory Cardiogenic Shock

排除标准

  • •Contraindications for ECMO
  • •Contraindications for Closed Loop Ventilation
  • •Rejection of participation

研究组 & 干预措施

Conventional Ventilation Mode

Active Comparator

Patients mechanically ventilated with a conventional mechanical ventilation mode until steady state is achieved for several hours.

干预措施: Conventional Mechanical Ventilation (Device)

Closed Loop Ventilation Mode

Experimental

Once steady state on the conventional mechanical ventilation mode is achieved for several hours, switch to closed loop ventilation mode for the remainder of the study period.

干预措施: Closed Loop Mechanical Ventilation (Device)

结局指标

主要结局

Change in Tidal Volumes

时间窗: Mixed Model Assessment at baseline (conventional mode), 0 (switch to closed loop), 8, 16, 24, 48 and 72 hours

Assessment of tidal volumes over the initial 72 hours post switch to closed loop mechanical ventilation

Change in Driving Pressure

时间窗: Mixed Model Assessment at baseline (conventional mode), 0 (switch to closed loop), 8, 16, 24, 48 and 72 hours

Assessment of Driving Pressure over the initial 72 hours post switch to closed loop mechanical ventilation

Change in Peak Pressure

时间窗: Mixed Model Assessment at baseline (conventional mode), 0 (switch to closed loop), 8, 16, 24, 48 and 72 hours

Assessment of Peak Pressure over the initial 72 hours post switch to closed loop mechanical ventilation

Change in Mechanical Power

时间窗: Mixed Model Assessment at baseline (conventional mode), 0 (switch to closed loop), 8, 16, 24, 48 and 72 hours

Assessment of Mechanical Power over the initial 72 hours post switch to closed loop mechanical ventilation

Change in Partial Pressure of Arterial Oxygen

时间窗: Mixed Model Assessment at baseline (conventional mode), 0 (switch to closed loop), 8, 16, 24, 48 and 72 hours

Assessment of Partial Pressure of Arterial Oxygen over the initial 72 hours post switch to closed loop mechanical ventilation

Change in Partial Pressure of Arterial CO2

时间窗: Mixed Model Assessment at baseline (conventional mode), 0 (switch to closed loop), 8, 16, 24, 48 and 72 hours

Assessment of Partial Pressure of Arterial CO2 over the initial 72 hours post switch to closed loop mechanical ventilation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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