Electrical Impedance Tomography During Flow Controlled Ventilation in the Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- End-expiratory lung volume
研究概览
简要总结
The goal of this clinical trial is to study the effects of Flow Controlled Ventilation (FCV) following conventional mechanical ventilation (Pressure or Volume Controlled Ventilation) in postcardiac surgery ICU-patients to allow for future power calculations and to obtain experience with FCV.
The main questions it aims to answer are:
- What is the effect of FCV on the lung volume measured by Electrical Impedance Tomography (EIT)?
- What is the effect of FCV on the minute volume?
- What is the effect of FCV on the mechanical power and dissipated energy?
Participants will be ventilated with PCV at baseline and then switched to FCV for 90 minutes while the lung volume, minute volume and mechanical power and dissipated energy levels are measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 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 or older;
- •Informed consent form signed by the subject or a legal representative;
- •Controlled mechanical ventilation via an endotracheal tube -
- •FiO2 ≤50% and PEEP 10 cmH2O or lower
排除标准
- •Severe sputum stasis or production requiring frequent bronchial suctioning (more than 5 times per nurse shift)
- •Severe respiratory insufficiency defined as a PaO2 to FiO2 ratio of <100mmHg or moderate to severe ARDS according to the Berlin definition of ARDS
- •Untreated pneumothorax (i.e. no pleural drainage)
- •Hemodynamic instability defined as a mean arterial pressure below 60mmHg not responding to fluids and/or vasopressors or a noradrenalin dose >0.4mg/kg/min
- •Excessive subcutaneous emphysema (prevents proper functioning of the EIT device)
- •Thoracic wounds, bandages or other obstruction which prevent proper functioning of the EIT device
- •High (>15 mmHg) or instable (an increase in sedation or osmotherapy is required) intracranial pressure
- •An inner tube diameter of 6mm or less
结局指标
主要结局
End-expiratory lung volume
时间窗: Baseline EELV compared to after 30 minutes of FCV (same ventilator settings)
The difference in End-expiratory lung volume (EELV) between PCV and FCV is measured using the difference in End-expiratory lung impedance (EELI) and tidal volume at baseline
次要结局
- Dissipated energy(The difference in Dissipated energy between PCV at baseline and after 90 minutes of FCV (after FCV optimization))
- Minute volume(The difference in minute volume between PCV at baseline and after 90 minutes of FCV (after optimization of FCV))
- Mechanical Power(The difference in Mechanical Power between PCV at baseline and after 90 minutes of FCV (after FCV optimization))
研究者
Henrik Endeman
H. Endeman, MD, PhD, Principle Investigator
Erasmus Medical Center