跳至主要内容
临床试验/NCT05141396
NCT05141396招募中不适用

Implementation of Coordinated Spontaneous Awakening and Breathing Trials Using Telehealth-Enabled, Real-Time Audit and Feedback for Clinician Adherence: A Type II Hybrid Effectiveness-Implementation

Intermountain Health Care, Inc.22 个研究点 分布在 1 个国家目标入组 13,400 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
13,400
试验地点
22
主要终点
Ventilator-free days to day 28

研究概览

简要总结

The purpose of this trial is to evaluate if augmenting a usual audit and feedback implementation approach with telehealth-enabled support improves coordinated spontaneous awakening/breathing trials and patient outcomes for mechanically ventilated patients.

详细描述

Sedation and analgesia are utilized with invasive mechanical ventilation (IMV) to improve patient comfort and synchrony with the mechanical ventilator. Prolonged sedation, however, may result in increased time on IMV and increased risk for ventilator associated pneumonia, delirium, and poor long-term cognitive outcomes. Daily interruptions in sedation [spontaneous awakening trials (SAT)] coordinated with daily spontaneous breathing trials (SBT) reduce mortality, increase ventilator free days, decrease intensive care unit (ICU) length of stay, and reduces ventilator-associated events. Coordination of spontaneous awakening and breathing trials (C-SAT/SBT), however, are underutilized due to significant barriers to implementation and adherence. This cluster-randomized hybrid implementation/effectiveness trial will compare C-SAT/SBT adherence and clinical outcomes in the presence of traditional audit and feedback implementation strategies alone or augmented with a novel Telehealth-Enabled, real-time Audit and feedback for Clinician adHerence ("TEACH") implementation strategy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Ventilator-free days to day 28

时间窗: 28 days

ventilator-free days to day 28

Adherence to C-SAT/SBT

时间窗: intubation to extubation - an average of 5 days

Fraction of eligible days on which coordinated spontaneous awakening trial and spontaneous breathing trial completed.

次要结局

  • 30-day Mortality(30 days)
  • 90-day Mortality(90 Days)
  • Reintubation(intubation to extubation - an average of 5 days)
  • Hospital Length of Stay(Through hospital discharge, an average of 10 days)
  • New ventilator-associated pneumonia(Through hospital discharge, an average of 10 days)
  • ICU Length of Stay(Through hospital discharge, an average of 10 days)
  • Unintentional Extubation(intubation to extubation - an average of 5 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (22)

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