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临床试验/NCT03185962
NCT03185962已完成不适用

Predictors Of Successful Extubation in Critically Ill Patients: Multicentre Observational Study

Osaka University1 个研究点 分布在 1 个国家目标入组 499 人开始时间: 2017年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
499
试验地点
1
主要终点
Implementation of reintubation within 48 hours after extubation

研究概览

简要总结

Extubation failure can directly worsen patient outcomes. Therefore, the decision to extubate is a critical moment during an intensive care unit (ICU) stay. The decision to extubate is usually made after a weaning readiness test involving spontaneous breathing on a T-piece or low levels of ventilatory assistance. However, extubation failure still occurs in 10 to 20% of patients. The investigators focused on previously reported physiological risk factors, and were able to obtain from common clinical practice: 1) age, 2) underlying cardiovascular disease, 3) underlying respiratory disease or occurrence of pneumonia, 4) rapid shallow breathing index (RSBI), 5) positive fluid balance during the previous 24 hours, 6) the ratio of arterial oxygen partial pressure to fractional inspired oxygen, 7) Glasgow Coma Scale, 8) respiratory tract secretions. The investigators aimed to assess the incidence and risk factors for extubation failure among critically ill patients who passed the 30 min spontaneous breathing test (SBT) using a low level of pressure support (PS) with positive end-expiratory pressure (PEEP), in a prospective multicenter study.

详细描述

Primary Outcome Measures:

Reintubation within 48 hours after extubation (logistic regression will be used to assess the risk factors)

Secondary Outcome Measures:

  • Use of non-invasive positive pressure ventilation or nasal high flow within 48 hours after extubation.
  • Risk factors for extubation failure, with quantitative variables expressed as means (standard deviation) or medians (interquartiles 25%-75%) and compared using the student t test or Wilcoxon test as appropriate
  • Length of ICU and hospital stay, vital status at ICU and hospital discharge, 28-day mortality

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

  • Mechanically ventilated for longer than 24 hours in Intensive Care Units
  • Extubated after successful the 30 min spontaneous breathing test using a low level of pressure support with positive end-expiratory pressure

排除标准

  • Decision not to reintubate
  • Unplanned extubation
  • Extracorporeal circulation
  • Patients who died within 48 hours after extubation

结局指标

主要结局

Implementation of reintubation within 48 hours after extubation

时间窗: 48 hours

logistic regression will be used to identify risk factors

次要结局

  • vital status at ICU and hospital discharge, 28-day mortality(28 days)
  • Use of non-invasive positive pressure ventilation or nasal high flow within 48 hours after extubation(48 hours)
  • Length of ICU and hospital stay,(28 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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