Optimal Timing for Tracheostomy in Invasively Mechanically Ventilated COVID-19 Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4,000
- 试验地点
- 1
- 主要终点
- Ventilator free days alive
研究概览
简要总结
Tracheostomy is a medical procedure performed on the front of a persons neck. It is used to create a connection between the persons trachea and a mechanical ventilator instead of using a tube going through the mouth into the trachea, oral intubation. Living with a tracheostomy tube is less stressful compared to oral intubation and facilitate being awake and the start of training on spontaneous ventilation in mechanically ventilated patients. Studies of the timing of tracheostomy are either severely affected by methodological bias of to small to determine an effect. Thus, it is not known what the optimal timing of the tracheostomy is in mechanically ventilated COVID-19 patients.
详细描述
The study hypothesis is that a strategy of tracheostomy during the second week of mechanical ventilation yields more IMV-free days and lower mortality than continued mechanical ventilation without tracheostomy, when efforts are made to neutralize immortal time bias.
The hypothesis has been slightly changed to accommodate the methods change described below.
Data sources Existing data provided for another project will be used.
Statistical methods:
A Markov multistate model with inverse probability weighting and landmark analyses at 7, 14, and 21 days from IMV start. The primary outcome is estimated ventilator-free days alive at day 60; secondary analyses includes 60-day mortality.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •admitted to an intensive care unit in Sweden from 2020 to 2021
- •Main discharge diagnosis COVID-19 (ICD-10, U07.1)
- •Invasive mechanical ventilation
排除标准
- •No Swedish personal identification number.
研究组 & 干预措施
Tracheostomised
Invasively mechanically ventilated COVID-19 patients who did receive a tracheostomy within 60 days from tracheal intubation.
干预措施: Tracheostomy (Procedure)
Not tracheostomised
Invasively mechanically ventilated COVID-19 patients who did not receive a tracheostomy within 60 days from tracheal intubation.
结局指标
主要结局
Ventilator free days alive
时间窗: 60 days.
Days alive without invasive mechanical ventilation during the first 60 days from start of invasive mechanical ventilation
次要结局
- 60 day mortality(60 days.)