跳至主要内容
临床试验/NCT04670523
NCT04670523招募中不适用

Early Postoperative Day 0 Chest Tube Removal After Thoracoscopic Minor Surgeries. A Randomized Controlled Clinical Trial.

Insel Gruppe AG, University Hospital Bern2 个研究点 分布在 1 个国家目标入组 304 人开始时间: 2023年1月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
304
试验地点
2
主要终点
2. Pleural effusion requiring thoracocentesis

研究概览

简要总结

The safe conditions for early chest tube removal have been progressively questioned and redefined around reliable digital air flow criteria and extension of liquid threshold accepted. Nevertheless, in current practice, the chest tube remains in restricting early mobilization and optimal compliance with ERAS programme, during the first crucial 24 h after surgery. Thus, to go further, the investigators decide to assess in this study the safety of POD 0 chest tube removal after minor thoracic operations in patients in health condition tolerating operation and anesthesia.

详细描述

Chest tube management is a key element of postoperative care after thoracic surgeries for different indications. During the last decade, minimally invasive surgery and enhanced recovery after surgery (ERAS) programmes have radically changed the equation of recovery, contributing to reduce postoperative morbidity and enhance quality of life, but the chest tube remains its Achilles heel, still providing postoperative pain and impairing pulmonary function. In this view, early chest tube removal has been widely promoted not only for its economic benefits on length of stay but also for improving quality of life and potentially reducing postoperative complications. In parallel, the change from traditional chest drainage devices to electronic devices has also enabled a more accurate air leak measurement with reduction of interobserver variability, decreased chest drainage duration and shortened LOS. The safe conditions for early chest tube removal have been progressively questioned and redefined around reliable digital air flow criteria and extension of liquid threshold accepted. Nevertheless, in current practice, the chest tube remains in restricting early mobilization and optimal compliance with ERAS programme, during the first crucial 24 h after surgery. Thus, to go further, the investigators decide to assess in this study the safety of POD 0 chest tube removal after minor thoracic operations in patients in health condition tolerating operation and anesthesia.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Thoracoscopic extra-anatomical lung resection (surgical lung biopsy)
  • Thoracoscopic pleural biopsy
  • Signed consent
  • Age of majority

排除标准

  • Anatomical resection
  • Pleural effusion
  • Pleurodesis
  • Vulnerable persons (Pregnant women, Children and adolescents)

结局指标

主要结局

2. Pleural effusion requiring thoracocentesis

时间窗: Pleural effusion 2 hours after chest tube removal between POD 0 and 30

Number of patients with pleural effusion requiring thoracocentesis after removal of first chest tube

3. Prolonged air leak > 5 days

时间窗: Chest tube removal between POD 6 and 30

Number of patients with persisting air leak longer than 5 days

1. Pneumothorax requiring chest tube reinsertion

时间窗: Pneumothorax 2 hours after chest tube removal between postoperative day 0 and 30 (POD 0 - 30)

Number of patients with pneumothorax requiring chest tube reinsertion after removal of initial chest tube

4. Re-admission or reoperation due to pleural complication

时间窗: Up to 1 month after first operation

Number of patients re-admitted to a hospital after first hospitalization

次要结局

  • 2. Re-operation(Up to 1 month after initial operation)
  • 3. Length of drainage (days)(Up to 1 month after initial operation)
  • 4. Length of stay (days)(Up to 1 month after initial operation)
  • 1. Cardiopulmonary complications (Pneumonia, Atrial fibrillation, ARDS)(Up to 1 month after initial operation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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