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临床试验/NCT07337408
NCT07337408尚未招募不适用

Characterization of Weaning Practices in ICUs of Global South Countries: A Prospective Observational Study

Hospital do Coracao0 个研究点目标入组 900 人开始时间: 2026年2月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
900
主要终点
Extubation failure within 7 days.

研究概览

简要总结

This is a prospective observational study to be conducted in intensive care units of Global South countries. Patients on mechanical ventilation for more than 12 hours who have initiated the weaning process and for whom the attending team plans extubation within the next 6 hours will be included. Data will be collected for each patient during the first 7 days after extubation, with follow-up until hospital discharge or death. We plan to conduct the study in intensive care units from Global South countries (low- and middle-income countries predominantly located in the Southern Hemisphere, though some in the Northern Hemisphere are also considered).

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

  • Age > 18 years.
  • Receiving care at an intensive care unit.
  • Endotracheal intubation.
  • Mechanical ventilation for 12 hours or more.
  • First separation attempt, as defined in the WIND Classification - "Separation attempt from mechanical ventilation: an spontaneous breathing trial with or without extubation, or an extubation directly performed without identified spontaneous breathing trial (whatever the type: planned or unplanned extubation)" - planned to occur in the next 6 hours or that occurred less than 2 hours ago.

排除标准

  • Patients with prior extubation failure.
  • Patients with prior spontaneous breathing trial failure.
  • Patients unable to obey commands.
  • Neuromuscular disease or cervical spinal cord injury.
  • Tracheostomy.
  • Do-not-resuscitate order or contraindication for reintubation.
  • Lack of informed consent.
  • Terminal extubation.
  • Previously included in the study.

结局指标

主要结局

Extubation failure within 7 days.

时间窗: 7 days.

Defined as reintubation or death within 7 days after extubation.

次要结局

  • Extubation within 28 days.(28 days.)
  • Intensive care unit length of stay.(At intensive care unit discharge, up to 28 days.)
  • Hospital length of stay.(At hospital discharge, up to 28 days.)
  • Reintubation or death within 28 days.(28 days.)
  • Intensive care unit mortality.(At intensive care unit discharge, up to 28 days.)
  • Number of spontaneous breathing trials.(28 days.)
  • Hospital mortality.(At hospital discharge, up to 28 days.)
  • WIND classification.(28 days.)

研究者

申办方类型
Other
责任方
Sponsor

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