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临床试验/NCT05563779
NCT05563779已完成不适用

Mode Of Ventilation During Critical Illness Pilot Trial

Vanderbilt University Medical Center1 个研究点 分布在 1 个国家目标入组 566 人开始时间: 2022年11月1日最近更新:
适应症
干预措施

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

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

Active Comparator

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

Active Comparator

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

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kevin P Seitz

Clinical Fellow

Vanderbilt University Medical Center

研究点 (1)

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