Mode Of Ventilation During Critical Illness Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 566
- 试验地点
- 1
- 主要终点
- Ventilator-free Days (VFDs) to Day 28 After Enrollment
研究概览
简要总结
Landmark trials in critical care have demonstrated that, among critically ill adults receiving invasive mechanical ventilation, the use of low tidal volumes and low airway pressures prevents lung injury and improves patient outcomes. Limited evidence, however, informs the best method of mechanical ventilation to achieve these targets. To provide mechanical ventilation, clinicians must choose between modes of ventilation that directly control tidal volumes ("volume control"), modes that directly control the inspiratory airway pressure ("pressure control"), and modes that are hybrids ("adaptive pressure control"). Whether the choice of the mode used to target low tidal volumes and low inspiratory plateau pressures affects clinical outcomes for critically ill adults receiving mechanical ventilation is unknown. All three modes of mechanical ventilation are commonly used in clinical practice. A large, multicenter randomized trial comparing available modes of mechanical ventilation is needed to understand the effect of each mode on clinical outcomes. The investigators propose a 9-month cluster-randomized cluster-crossover pilot trial evaluating the feasibility of comparing three modes (volume control, pressure control, and adaptive pressure control) for mechanically ventilated ICU patients with regard to the outcome of days alive and free of invasive mechanical ventilation.
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
- Single (Outcomes Assessor)
盲法说明
Observer bias will be minimized by use of objective endpoints collected in duplicate by [1] study personnel blinded to group assignment and [2] automated data extraction from the electronic health record.
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
- •Age ≥ 18 years
- •Receiving mechanical ventilation through an endotracheal tube or tracheostomy
- •Admitted to the study ICU
排除标准
- •Patient is pregnant
- •Patient is a prisoner
- •Patient receiving invasive mechanical ventilation at place of residence prior to hospital admission
- •Patient receiving extracorporeal membrane oxygenation at the time of admission to the study ICU
研究组 & 干预措施
Volume Control mode
During invasive mechanical ventilation in a study location, Volume Control will be used as the mode for continuous mandatory ventilation.
干预措施: Volume Control mode (Other)
Pressure Control mode
During invasive mechanical ventilation in a study location, Pressure Control will be used as the mode for continuous mandatory ventilation.
干预措施: Pressure Control mode (Other)
Adaptive Pressure Control mode
During invasive mechanical ventilation in a study location, Adaptive Pressure Control will be used as the mode for continuous mandatory ventilation.
干预措施: Adaptive Pressure Control mode (Other)
结局指标
主要结局
Ventilator-free Days (VFDs) to Day 28 After Enrollment
时间窗: Enrollment to 28 days
Number of days alive and free from invasive mechanical ventilation between the final liberation from invasive mechanical ventilation before 28 days and study day 28. Patients who continue to receive invasive mechanical ventilation at day 28 or have died prior to day 28 will receive zero VFDs. For patients who return to invasive mechanical ventilation and are subsequently liberated from invasive mechanical ventilation prior to day 28, VFDs will be counted from final liberation from mechanical ventilation.
次要结局
未报告次要终点
研究者
Kevin P Seitz
Clinical Fellow
Vanderbilt University Medical Center
