Adaptive Support Ventilation in Acute Respiratory Distress Syndrome
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
- Tidal Volume
研究概览
简要总结
The purpose of this protocol is to compare standard of care lung protective ventilation settings with an automated ventilator setting, called Adaptive Support Ventilation (ASV), in patients with acute respiratory distress syndrome (ARDS). This study will compare measurements (i.e. tidal volumes, driving pressure, respiratory rate (RR), compliance, peak airway pressures, plateau pressures, PEEP) with each ventilator technique, and will measure esophageal pressures to compare transpulmonary and respiratory system mechanics.
详细描述
This study will compare two different modes of mechanical ventilation: standard lung protective controlled mandatory ventilation and Adaptive Support Ventilation. The investigators will enroll adult patients with ARDS who are mechanically ventilated and admitted to intensive care units, capturing a population with respiratory failure and significant critical illness. Patient mechanics during each ventilation strategy will be compared before and after crossover.
After obtaining informed consent, the investigators will place an esophageal balloon which will be used for simultaneous measurements of airway pressures (Pao) and esophageal pressures (Pes), to estimate transpulmonary pressures (PL = Pao - Pes), while also measuring Flow and Volume. Use of esophageal balloon catheters is common practice in the ICUs, and standard of care at Beth Israel Deaconess Medical Center is to use these balloons in patients with ARDS. Both the respiratory therapy and physician staff are very comfortable with placement and use. The esophageal balloon will be left in place until extubation. If the balloon is dislodged or removed for clinical purposes, it will not be replaced solely for research purposes unless it occurs on the first day of study measurements.
Patients will then be randomized to be switched to ASV immediately or to be maintained on their current lung protective ventilation settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Patients ≥ 18 years of age
- •Receiving mechanical ventilation in an intensive care unit
- •ARDS, as defined by the Berlin definition:
- •Hypoxemic respiratory failure with PaO2 / FiO2 ratio < 300 mmHg
- •Bilateral alveolar/interstitial infiltrates on chest x-ray, with opacities not present for more than 7 days
- •Respiratory failure not fully explained by cardiac failure or fluid overload
- •Intubation on mechanical ventilation and receiving PEEP ≥ 5 cm H2O
- •Receiving mechanical ventilation from a Hamilton ventilator, on a controlled mode of ventilation.
排除标准
- •Clinical team refusal
- •Esophageal injury or contraindication precluding placement of the esophageal balloon
结局指标
主要结局
Tidal Volume
时间窗: Day 1
Lung tidal volume in both ventilation modes (mL)
次要结局
- Oxygenation (SpO2%)(Day 1)
- CO2 clearance(Day 1)
- Driving Pressure (cmH20)(Day 1)
- Respiratory rate (BPM)(Day 1)
- Blood Gas Partial Pressure of Oxygen(Day 1)
- Blood Gas Partial Pressure of Carbon Dioxide (PaCO2) (mm Hg)(Day 1)
- Composite measure (lung protectiveness) - Oxygen saturation by pulse Oximetry (SpO2) >88%(Day 1)
- Time to extubation(30 Days)
- ICU length of stay(90 Days)
- Blood Gas pH(Day 1)
- Composite measure (lung protectiveness) - Asynchrony index(Day 1)
- Composite measure (lung protectiveness) - Number of Adjustments(Day 1)
- Composite measure (lung protectiveness) - Time with tidal volumes under 6cc/kg(Day 1)
- Composite measure (lung protectiveness) - Driving pressures less than 15(Day 1)
- Composite measure (lung protectiveness) - Plateau Pressure <30(Day 1)
研究者
Daniel Talmor
Edward Lowenstein Professor of Anesthesia
Beth Israel Deaconess Medical Center