Airway Pressure Release Ventilation (APRV) vs. Conventional Volume Control Mechanical Ventilation for Patients With Respiratory Failure Requiring Invasive Mechanical Ventilator Support
试验速览
- 阶段
- 2 期
- 入组人数
- 246
- 试验地点
- 4
- 主要终点
- P/F Ratio on Day 3 of Mechanical Ventilation
研究概览
简要总结
APRV mode of ventilation will result in an improved partial pressure of arterial oxygenation/ fraction of inspired oxygen (P/F ratio) on day 3 of mechanical ventilation. Sub hypotheses: APRV will be associated with a reduced amount of sedation used during the ICU stay in patients with respiratory failure. APRV will be associated with a reduction in the amount of vasoactive medication used for blood pressure support in patients with respiratory failure.
详细描述
This prospective un-blinded randomized trial will follow patients with respiratory failure and ALI/ARDS who require invasive mechanical ventilation in select ICUs. Patients will be allocated to respiratory support with either APRV mode or volume control (AC) mode of mechanical ventilation. Qualifying patients will be randomized by permuted block randomization within 24 hours of admission to the ICU. Identical ventilation and oxygenation thresholds will be utilized to guide titration of each ventilator protocol. Patients will remain on the assigned mode of ventilation until they are extubated and discharged from the ICU.
Procedures for treatment evaluation include daily monitoring of the Ventilator protocol in each arm. Clinical coordinator and study respiratory therapist will perform 2 daily checks of the study patients to determine compliance with the protocol and if patient meets weaning criteria. The previously published ARDS Network continuous positive airway pressure (CPAP) weaning protocol will be used for all patients enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Hypoxemic respiratory failure requiring mechanical ventilation for >24 hours.
排除标准
- •Age under 18
- •Severe chronic obstructive lung disease
- •Patients in whom the only indication for mechanical ventilation is airway protection from poor neurological status.
结局指标
主要结局
P/F Ratio on Day 3 of Mechanical Ventilation
时间窗: Day 3
Our first objective is to measure and compare the partial pressure of oxygen in the artery to the inspired oxygen ratio (P/F ratio) on day 3 of mechanical ventilation. We will also collect and compare common variables used to evaluate lung injury and severity of respiratory failure in both groups. These variables and markers include: the Oxygenation index (OI) and standard blood gas parameters (PH, PaCO2 and PaO2).
次要结局
- Amount/Duration of Sedative & Vasoactive Medication(Up to ICU discharge)
- Evaluate Feasibility & Clinical Compliance with 2 APRV Paper Protocols.(Up to ICU discharge)
研究者
Eliotte L. Hirshberg
Principal Investigator
Intermountain Health Care, Inc.