Non-intubated vs Intubated Anesthesia for Tracheal and Carinal Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 176
- 试验地点
- 2
- 主要终点
- Conversion rate
研究概览
简要总结
In recent year, non-intubated anesthesia had emerged as an available alternative for thoracic procedure. Whether non-intubated tracheal/carinal reconstruction confers distinct perioperative advantages over the conventional intubated approach remains uncertain. The purpose of this study was to evaluate the safety and perioperative outcomes of non-intubated versus intubated approaches in tracheal and carinal reconstruction.
详细描述
Tracheal/carinal resection and reconstruction remains a technically demanding procedure with high risks of morbidity and mortality. Traditionally, tracheal surgery is performed under intubated anesthesia, with intermittent endotracheal ventilation to maintain oxygenation during airway reconstruction. However, endotracheal intubation with cross-field ventilation obstructs the surgical field and potentially complicating the reconstruction procedure. Non-intubated anesthesia have has gained widespread adoption for modern thoracic surgery. However, the safety and feasibility of non-intubated tracheal and carinal reconstruction have not been studied by randomized controlled trial. So, this randomized controlled trial aims to evaluate whether the non-intubated approach offers comparable short-term and long-term outcomes to the conventional intubated procedure.
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
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Airway diseases were diagnosed by chest enhanced CT and bronchoscopy
- •The patients with age ≥ 18 and ≤ 80 years old
- •ASA (American Society of Anesthesiologists) stage: I-III
- •sign the informed consent. -
排除标准
- •The patients have proved history of congestive heart failure, angina without good control with medicine; ECG-proved penetrating myocardial infarction; hypertension with bad control; valvulopathy with clinical significance; arrhythmia with high risk and out of control
- •The patients have severe systematic intercurrent disease, such as active infection or poorly controlled diabetes; coagulation disorders; hemorrhagic tendency or under treatment of thrombolysis or anticoagulant therapy
- •Airway anatomical abnormalities due to a history of surgery
- •Patients present with other malignancy
结局指标
主要结局
Conversion rate
时间窗: postoperative in-hospital stay up to 30 days
The rate of conversion to intubated approach in the operation
Postoperative complications rate
时间窗: postoperative in-hospital stay up to 30 days
Number and severity of adverse events that are related to the treatment of each patient. Postoperative treatment-related complications were assessed by the Clavien-Dindo Classification. Treatment-related adverse events as assessed by CTCAE v5.0.
次要结局
- Operative time(postoperative in-hospital stay up to 30 days)
- Length of stay (LOS)(postoperative in-hospital stay up to 30 days)
- Postoperative ICU stay(postoperative in-hospital stay up to 30 days)
- Length of resection(postoperative in-hospital stay up to 30 days)
- Reconstruction time(postoperative in-hospital stay up to 30 days)
- 1-year disease-free survival (DFS)(1 year after surgery)
- Intraoperative bleeding loss(postoperative in-hospital stay up to 30 days)
- Volume of postoperative drainage(postoperative in-hospital stay up to 30 days)
- 1-year overall survival(OS)(1 year after surgery)
研究者
Shuben Li
Deputy Director
The First Affiliated Hospital of Guangzhou Medical University