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临床试验/NCT03225807
NCT03225807已完成不适用

Implementation of Lung Protective Ventilation in Patients With Acute Respiratory Failure

Intermountain Health Care, Inc.1 个研究点 分布在 1 个国家目标入组 8,692 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
8,692
试验地点
1
主要终点
Ventilator free days to day 28

研究概览

简要总结

This is a quality improvement study with the purpose of observing and measuring the effects of implementation of a proven standardized lung protective ventilation protocol in the new electronic medical record system iCentra across all Intermountain Healthcare hospitals. Approximately 14,000 records will be accessed for this study from a database of mechanically ventilated patients established for quality improvement purposes.

The investigators hypothesize that implementation of a standardized computerized lung protective ventilation protocol across all Intermountain Healthcare hospitals will be feasible, will decrease initial tidal volumes to the target 6 ml/kg PBW, and will improve outcomes.

The objectives of this study are to:

  • Determine if the implementation of lung protective ventilation (with a 6 ml/kg PBW tidal volume ventilation protocol on initiation of mechanical ventilation) improves outcomes in patients with acute respiratory failure requiring mechanical ventilation
  • Determine if the implementation of lung protective ventilation (with a 6 ml/kg PBW tidal volume ventilation protocol on initiation of mechanical ventilation) improves outcomes in the sub-group of patients with the acute respiratory distress syndrome (ARDS)
  • Measure compliance with the implementation of a computerized lung protective ventilation protocol at 12 Intermountain Healthcare hospitals

详细描述

Study Design:

This is an observational quality improvement study comparing outcomes before, and after, implementation of a proven lung protective ventilation protocol in an electronic medical record system, iCentra, that will be implemented in phases across Intermountain Healthcare hospitals. A phased implementation with a two-month washout period will be used to evaluate the primary outcome of interest, ventilator free days (VFDs) to 28 days. Secondary outcomes will include: use of the protocol by clinicians, compliance with protocol instructions, hospital discharge disposition, hospital, 30-day, and 90-day mortality, time to first ICU activity, hospital length of stay, ICU length of stay, heath care utilization, quality of life, and costs of care. As the iCentra electronic medical record is implemented at Intermountain Healthcare hospitals, clinicians will have the opportunity to use the computerized lung protective ventilation protocol, or to order mechanical ventilation settings independently. This is an observational study designed to measure how often the computerized lung protective ventilation protocol will be ordered, compliance with the instructions of the protocol, and clinical outcomes among patients who are managed with the protocol. Physicians may choose to use the protocol on intubated patients requiring mechanical ventilation or they may choose to order other specific mechanical ventilator settings.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • 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

次要结局

  • Hospital mortality(1 week)
  • 30 day mortality(30 days)
  • 90 day mortality(90 days)
  • Hospital discharge disposition(30 days)
  • Time to first ICU activity(24 hours)

研究者

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

Colin Grissom

Principal Investigator

Intermountain Health Care, Inc.

研究点 (1)

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