Comparison Between Spontaneous Breathing Trials Through Pressure-Support Ventilation or "T" Tube in the Weaning of Mechanical Ventilation in Patients With Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- Days Spent on Mechanical Ventilation
研究概览
简要总结
Weaning of mechanical ventilation (MV) is an essential part in management of patients with Chronic Obstructive Pulmonary Disease (COPD) when critically ill. The best strategy to be used has not been established.
Objective: To compare the Spontaneous Breathing Trial (SBT) in Pressure Support Ventilation with SBT through "T" tube in weaning of MV in patients with COPD.
Design: Randomized Clinical Trial. Methods: This study will include patients with COPD, admitted to the Intensive Care Unit of Hospital Nossa Senhora da Conceição, undergoing MV for at least 48 hours. When considered by the care team ready for SBT, they will be randomized to one of the following strategies: SBT in Pressure Support or SBT through "T" Tube. The primary endpoint of this study will be the reduction in the days spent on MV. Other outcomes measured will be mortality, extubation and success rate, time to weaning of MV, length of ICU stay and incidence of tracheostomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •COPD patients admitted to our ICU for Acute Respiratory Failure, submitted to Mechanical Ventilation for at least 48 hours
- •18 years or older
排除标准
- •Tracheostomy
- •Younger than 18 years
- •Refuse to give informed consent
- •Individuals who are already enrolled in another clinical trial
结局指标
主要结局
Days Spent on Mechanical Ventilation
时间窗: Participants will be followed for the duration of ICU stay, an expected average of 2 weeks
次要结局
- Mortality(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- Extubation success rate(Participants will be followed for the duration of ICU stay, an expected average of 4 weeks)
研究者
Jose Augusto Santos Pellegrini
Principal Investigator
Hospital Nossa Senhora da Conceicao