Ultrasound Guided Percutaneous Tracheostomy Compared to Bronchoscopy Guided Percutaneous Tracheostomy - A Randomized Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Procedure failure
研究概览
简要总结
TRACHUS trial is a randomized non-inferiority trial designed to evaluate the safety and efficacy of ultrasound guided percutaneous tracheostomy compared to bronchoscopy guided percutaneous tracheostomy.
详细描述
TRACHUS trial is a randomized non-inferiority trial designed to evaluate the safety and efficacy of ultrasound guided percutaneous tracheostomy compared to bronchoscopy guided percutaneous tracheostomy.
Patients will be randomly assigned to be submitted to ultrasound or bronchoscopy guided percutaneous tracheostomy and then the procedure related complications and clinical outcomes will be evaluated and compared between groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All intubated and mechanically ventilated patients indicated for a tracheostomy by the ICU assistant team
排除标准
- •Patients with unfavorable anatomy judged by the patient assistant team (short neck, tracheal deviation, cervical anatomical anomaly, previous cervical surgery, cervical trauma or inability to perform neck extension), preference for surgical tracheostomy by the patient assistant team or patients unable to provide informed consent.
结局指标
主要结局
Procedure failure
时间窗: During PDT - an expected average of 15 minutes
Combined endpoint procedure failure (defined as conversion to surgical tracheostomy, or associated use of bronchoscopy in the case of ultrasound-guided tracheostomy or associated use of ultrasound in bronchoscopy-guided tracheostomy) or occurrence of of a major complications defined as transfusion, hypotension or surgical intervention in the operative room due to bleeding, tracheal laceration, tracheal posterior wall injury, esophageal injury, tracheoesophageal fistula, cardiorespiratory arrest or death due to tracheostomy.
次要结局
- Hypoxemia(During PDT - an expected average of 15 minutes)
- Atelectasis(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- Conversion to surgical tracheostomy(During PDT - an expected average of 15 minutes)
- Death(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- Liberation from mechanical ventilation(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- Major bleeding(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- Pneumothorax(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- Accidental decanulation(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- Length of Hospital Stay(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- Length of Mechanical Ventilation(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- Minor bleeding(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- Hypotension(During PDT - an expected average of 15 minutes)
- Tracheal posterior wall injury(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- Cardiorespiratoty arrest(During PDT - an expected average of 15 minutes)
- Surgical site infection(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- Length of ICU Stay(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- Tracheal ring fracture(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- Tracheal-esophageal fistula(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
研究者
Luiz Marcelo Sá Malbouisson
MD, PhD
University of Sao Paulo