The Ultrasound-guided Versus Bronchoscopy-guided vs Ultrasound-bronchoscopy-guided Percutaneous Dilational Tracheostomy Trial - Standardization or Customization?
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- PDT feasibility/failure
研究概览
简要总结
This trial (BRONCUS) is a randomized one designed to evaluate the overall safety of ultrasound guided compared to bronchoscopy guided compared to ultrasound-bronchoscopy guided percutaneous tracheostomy, in order to find out if universal standardization is required or customized approach can be sufficient.
详细描述
Enrolled patients will be randomized in a 1:1:1 ratio to ultrasound or bronchoscopy or ultrasound-bronchoscopy arms, and then the procedure related complications and clinical outcomes will be evaluated and compared between the groups. The procedures will be performed according to standardized practices following hospital guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 是
入选标准
- •adult patients (over 18 years old), intubated, mechanically ventilated, and with an indication for a tracheostomy
排除标准
- •Patients with contraindications for PDT:
- •short neck
- •tracheal deviation
- •difficult anatomy
- •previous neck surgery
- •cervical trauma or inability to perform neck extension
- •preference for surgical tracheostomy by the patient assistant team
- •patients unable to provide informed consent
结局指标
主要结局
PDT feasibility/failure
时间窗: During PDT - 15-25 minutes
Conversion to a surgical tracheostomy in any case, associated use of bronchoscopy in the case of ultrasound-guided PDT, associated use of ultrasound in the case of bronchoscopy-guided PDT, or the occurrence of a major complication.
次要结局
- ICU mortality(During hospital LOS (an expected average of 4 weeks ))
- Hospital mortality(During hospital LOS (an expected average of 4 weeks))
- Minor complication - hypotension(During PDT (an expected average of 15-30 minutes))
- Lenght of ICU stay((an expected average of 4 weeks))
- Procedure duration(During PDT (an expected average of 15-30 minutes))
- Minor complication - Localized minor bleeding(During PDT (an expected average of 15-30 minutes))
- Procedure difficulty(During PDT (an expected average of 15-30 minutes))
- Mechanical ventilation(During hospital LOS (an expected average of 4 weeks))
- Lenght of hospital stay((an expected average of 4 weeks))
- Minor complication - hypoxemia(During PDT (an expected average of 15-30 minutes))
- Minor complication - Tracheostomy stoma infection(During hospital LOS (an expected average of 4 weeks))
- Minor complication - Accidental decannulation(During hospital LOS (an expected average of 4 weeks))
- Minor complication - Localized subcutaneous emphysema(During PDT (an expected average of 15-30 minutes))
研究者
Constantinescu Catalin
Assistant lecturer, PhD
Iuliu Hatieganu University of Medicine and Pharmacy