Unraveling the (Patho)Physiological Mechanisms and Potential Clinical Benefits of an Early Switch From Controlled to Assisted Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Regional lung stress
研究概览
简要总结
The goal of this physiological intervention study is to unravel the (patho)physiological mechanisms and potential clinical benefits of a pre-specified early switch from controlled to assisted ventilation in mechanically ventilated adult patients with acute hypoxemic respiratory failure (PaO2/FiO2 ratio < 200 mmHg).
The intervention is that participants will be switched from controlled to assisted ventilation when PaO2/FiO2 ratio > 200 mmHg.
The primary endpoint is the change in regional lung stress (as derived by electrical impedance tomography) when switching from controlled to assisted ventilation and until a successful or failed switch.
详细描述
A crucial milestone in the trajectory of the mechanically ventilated patient is the switch from fully controlled mechanical ventilation to assisted ventilation. This switch should be made as early as feasible and safe, to limit the detrimental effects from prolonged controlled ventilation and sedation. However, there is also indirect evidence that excessive breathing effort during assisted ventilation may worsen lung injury (P-SILI). There are no guidelines that address this important switch moment.
Therefore, the overall aim of this physiological intervention study is to unravel the (patho)physiological mechanisms and potential clinical benefits of a pre-specified early switch from controlled to assisted ventilation in mechanically ventilated adult patients with acute hypoxemic respiratory failure (PaO2/FiO2 ratio < 200 mmHg).
Participants will be switched from controlled to assisted ventilation switch when PaO2/FiO2 ratio > 200 mmHg and will be monitored continuously using electrical impedance tomography, and oesophageal and gastric pressure until 4 hours post-switch and twice daily for 72 hours or until switch failure (switch back to controlled ventilation within 72 hours).
The primary endpoint is the change in regional lung stress (as derived by electrical impedance tomography) when switching from controlled to assisted ventilation and until a successful or failed switch.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •18 years old
- •Written informed consent from a legal representative
- •Mechanical ventilation via an endotracheal tube
- •Acute hypoxemic respiratory failure with PaO2/FiO2 ratio < 200 mmHg
- •Under continuous sedation with or without paralysis
排除标准
- •Expected mechanical ventilation duration of <48 hours
- •Pure chronic obstructive pulmonary disease exacerbation
- •Pre-existent respiratory muscle disease
- •Contraindication to EIT monitoring (as per clinical protocol, e.g. pacemaker, burns or thoracic wounds limiting electrode placement)
- •Contra-indications to oesophageal manometry (as per clinical protocol, e.g., recent oesophageal surgery, oesophageal varices, severe bleeding disorders)
- •Known pregnancy
- •Anticipating withdrawal of life support and/or shift to palliation as the goal of care
研究组 & 干预措施
Mechanically ventilated adults
Switch from controlled to assisted mechanical ventilation when PaO2/FiO2-ratio > 200 mmHg.
Before switch (on controlled ventilation) participants will undergo an electrical impedance tomography (EIT) perfusion measurement as well as a photon-counting CT (PCCT) scan to assess lung perfusion and ventilation/perfusion mismatch. From 15 minutes before until 4 hours after switch and 30 minutes twice daily for 72 hours or until switch failure participants will be monitored continuously using EIT, esophageal pressure and gastric pressure.
干预措施: Pre-specified switch from controlled to assisted ventilation when PaO2/FiO2-ratio > 200 mmHg (Other)
结局指标
主要结局
Regional lung stress
时间窗: 72 hours
The change in regional lung stress as derived from EIT recordings by computing the regional ventilation distribution (ventral-to-dorsal ratio).
次要结局
- Blood inflammatory biomarkers(72 hours)
- Patient-ventilator asynchrony(72 hours)
- Photon-Counting Computed Tomography (PCCT)-derived ventilation/perfusion mismatch(30 minutes)
- Breathing effort(72 hours)
- Electrical Impedance Tomography (EIT) parameters(72 hours)
- Electrical Impedance Tomography (EIT)-derived ventilation/perfusion mismatch(30 minutes)
- Respiratory mechanics(72 hours)
- Gas exchange(72 hours)
- Hemodynamics(72 hours)
- Breath condensate inflammatory biomarkers(72 hours)
- Ventilator-free days(28 days)
研究者
Annemijn Jonkman
Assistant Professor
Erasmus Medical Center