Use of Electrical Impedance Tomography for Optimization of Positive End-Expiratory Pressure in Acute Respiratory Distress Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Mechanical Power
研究概览
简要总结
Doctors follow a standard ventilator management strategy when making adjustments to the breathing machine to optimize the amount of oxygen into the lungs. The purpose of this study is to assess whether the EIT (electrical impedance tomography) device can be an additional useful tool for ventilator management and identifying the ideal positive end-expiratory pressure (PEEP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Endotracheal ventilation for < 1 week (168 hours)
- •Presence of all of the following conditions for < 48 hours i. Partial pressure of oxygen to percentage of inspired oxygen (PaO2/FiO2) < 150 with PEEP > 5 cm water for > 30 min.
- •ii. bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules iii. respiratory failure not fully explained by cardiac failure or fluid overload
- •All criteria listed in (3) developed within 1 week of a known clinical insult or new or worsening respiratory symptoms
排除标准
- •Lack of informed consent
- •Known pregnancy
- •Extracorporeal membrane oxygenation (ECMO) use
- •Severe chronic respiratory disease requiring home oxygen therapy or ventilation
- •Calculated BMI of greater than 50
结局指标
主要结局
Mechanical Power
时间窗: Participants received Treatment 1 (either Usual Care or PEEP EIT) for approximately 6 hours after randomization and then received Treatment 2 for an additional 14-18 hours following crossover. Measurement was done at end of treatment.
Mechanical power (MP) is the energy imparted to the lung from the mechanical ventilator. It is calculated as listed below, where respiratory rate = RR, tidal volume = TV, Ppeak = peak airway pressure, Pplat = plateau airway pressure and PEEP = positive end-expiratory pressure. Mechanical power determined for the difference between Treatment 1 and Treatment 2. Values shown represent data gathered at the end of the designated assignment listed below, regardless of whether that assignment was Treatment 1 or Treatment 2. MP = 0.098 X RR X TV (Ppeak-\[Pplat-PEEP/2\])
次要结局
- Change in Lung Inflammation as Measured by Physiologic Parameter: Partial Pressure of Arterial Oxygen/Fraction of Inspired Oxygen (P/F Ratio)(Participants received Treatment 1 (either Usual Care or PEEP EIT) for approximately 6 hours after randomization and then received Treatment 2 for an additional 14-18 hours following crossover. Measurement was done at baseline and end of treatment.)
- Change in Lung Inflammation as Measured by Physiologic Parameter: Plateau Pressure(Participants received Treatment 1 (either Usual Care or PEEP EIT) for approximately 6 hours after randomization and then received Treatment 2 for an additional 14-18 hours following crossover. Measurement was done at baseline and end of treatment.)
- Lung Inflammation as Measured by Physiologic Parameter: Driving Pressure(Participants received Treatment 1 (either Usual Care or PEEP EIT) for approximately 6 hours after randomization and then received Treatment 2 for an additional 14-18 hours following crossover. Measurement was done at end of treatment.)
- Change in Lung Inflammation as Measured by Physiologic Parameter: Static Compliance(Participants received Treatment 1 (either Usual Care or PEEP EIT) for approximately 6 hours after randomization and then received Treatment 2 for an additional 14-18 hours following crossover. Measurement was done at baseline and end of treatment.)
- Dynamic Compliance (Cdyn)(Participants received Treatment 1 (either Usual Care or PEEP EIT) for approximately 6 hours after randomization and then received Treatment 2 for an additional 14-18 hours following crossover. Measurement was done at end of treatment.)
- Ultrasound Surrogates of Lung Aeration(Participants received Treatment 1 (either Usual Care or PEEP EIT) for approximately 6 hours after randomization and then received Treatment 2 for an additional 14-18 hours following crossover. Measurement was done at end of treatment.)
- Change in Compliance Over the Last 20% of Inspiration (C20/Dyn)(Participants received Treatment 1 (either Usual Care or PEEP EIT) for approximately 6 hours after randomization and then received Treatment 2 for an additional 14-18 hours following crossover. Measurement was done at baseline and end of treatment.)
- Partial Pressure of Arterial Oxygen (PaO2)(Participants received Treatment 1 (either Usual Care or PEEP EIT) for approximately 6 hours after randomization and then received Treatment 2 for an additional 14-18 hours following crossover. Measurement was done at end of treatment.)
研究者
Robert C. Hyzy, MD
Professor of Internal Medicine
University of Michigan