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临床试验/NCT01885507
NCT01885507已完成不适用

Duration of Mechanical Ventilation and Mortality Among Brain-injured Patients - a Before-after Evaluation of a Quality Improvement Project

Nantes University Hospital21 个研究点 分布在 1 个国家目标入组 560 人开始时间: 2013年7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
560
试验地点
21
主要终点
Mechanical ventilatory free days

研究概览

简要总结

Protective ventilation (association of a tidal volume < 8 ml/kg with a positive end expiratory pressure) is poorly used in severe brain-injured patients. Moreover, a systematic approach to extubation may decrease the rate of extubation failure and enhance outcomes of brain-injured patients.

We hypothesized that medical education and implementation of an evidence-base care bundle associating protective ventilation and systemic approach to extubation can reduce the duration of mechanical ventilation in brain-injured patients.

详细描述

A before/after study design will be used. The before period (control phase) will consisted of all consecutive patients with severe brain-injury who were admitted to the participating ICUs.

During the interphase, all physicians, residents, physiotherapists and nurses will receive a formal training for the processes and procedures related to the 2 point bundle: protective ventilation and systematic approach to extubation (according to recommendation for the use of tidal volume < 7 ml/kg and of a positive expiratory pressure = 6 to 8 cmH20 (centimeter of water) and extubation as soon as ventilatory weaning is associated with a glasgow coma scale equal or above 10 and cought).

The after period consisted of all consecutive severe brain-injured patients admitted to the participating ICUs after the formal training.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • Adult patients (traumatic brain-injured, subarachnoid hemorrhage, stroke or other)
  • Brain injury (Glasgow Coma Scale ≤ 12 associated with at least one anomaly related to an acute process on head tomographic tomodensitometry
  • mechanical ventilation for more than 24 hours

排除标准

  • early decision to withdraw care (taken in the first 24 hours in ICU),
  • death in the first 24 hours

结局指标

主要结局

Mechanical ventilatory free days

时间窗: Day-90

The number of ventilator-free days was defined as the number of days from day 1 to day 90 on which a patient breaths spontaneously and is alive

次要结局

  • Acute respiratory distress syndrome / acute lung injury(day-90)
  • Mortality(day-90)
  • ICU free days at day 90(day 90)
  • Intracranial pressure(day-5)
  • Ventilatory setting(day-5)
  • In-ICU mortality(90 days)
  • Extubation failure(day-90)
  • Duration of mechanical ventilation(90 days)
  • Hospital acquired pneumonia(day-90)
  • Blood gaz(day-5)
  • Glasgow outcome scale(day-90)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (21)

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