Multicenter Randomized Controlled Clinical Trial of Thoracoscopic Bullectomy Surgery Under Nonintubated Intravenous Anesthesia With Spontaneous Ventilation
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- numbers of participants with postoperative respiratory and cardiovascular complications
研究概览
简要总结
With the development of video-assisted thoracoscopic surgery (VATS) techniques and technology for anesthesia control, non-intubated anesthesia with spontaneous ventilation has been widely applied in VATS. A multicenter randomized parallel controlled study was applied in this study to assess the efficacy and safety of thoracoscopic bullectomy surgery under intravenous anesthesia with spontaneous ventilation versus tracheal intubation general anesthesia.
详细描述
Intubated anesthesia with single lung mechanical ventilation (IASLV) is considered the standard of care in VATS. However, this type of anesthesia has been associated with several adverse effects, which can trigger complications and increase the overall surgical risk. In order to avoid intubated-anesthesia-related adverse effects, nonintubated strategies have been proposed in recent years.Encouraged by the satisfactory results with a preliminary experience of nonintubated VATS, the multicenter randomized parallel controlled study is established to comparatively analyze the outcome of patients undergoing either nonintubated intravenous anesthesia with spontaneous ventilation (NIIASV) or IASLV VATS thoracoscopic bullectomy surgery，especially in complication rate, safety during operation, muscle recovery after surgery, the difference the postoperative hospitalization time.
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
- 16 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •volunteering to participate in clinical trials and having the ability of responsibility can be signed informed consent.
- •16-50 years old
- •preoperative chest CT diagnosed with "localized lung bulla" and needing surgical treatment
- •Eastern Cooperative Oncology Group(ECOG) score standard ≤ 1
- •ASA（American Society of Anesthesiologists score） ≤ 2
- •Heart ejection fraction( EF)≥ 50%
排除标准
- •refusing to participate in clinical trials
- •A history of tuberculosis or other diseases could cause pleural adhesion or more pleural effusion
- •BMI ≥ 25 kg/m^2
- •other not suitable situations
研究组 & 干预措施
NIIASV
undergoing Thoracoscopic Bullectomy Surgery under nonintubated intravenous anesthesia with spontaneous ventilation(NIIASV)
干预措施: Thoracoscopic Bullectomy Surgery (Procedure)
IASLV
undergoing Thoracoscopic Bullectomy Surgery under intubated anesthesia with single-lung mechanical ventilation(IASLV)
干预措施: Thoracoscopic Bullectomy Surgery (Procedure)
结局指标
主要结局
numbers of participants with postoperative respiratory and cardiovascular complications
时间窗: from operation to discharging, an average of 1 week
The numbers of participants with postoperative respiratory and cardiovascular complications will be reported. The postoperative complications include postoperative respiratory complications(e.g., air leaks, lung infections, atelectasis, and bronchospasm and respiratory failure), postoperative cardiovascular complications(e.g., arrhythmias, myocardial infarction, cardiac failure) , intubated related complications(e.g., hoarseness, sore throat, and irritating cough), and other undefined complications
次要结局
- numbers of participants with unstable vital signs, hypoxemia or hypercapnia intraoperatively(during the surgical operation, an average of 1 hour)
- numbers of participants with anesthesia conversion intraoperatively in nonintubated group(during the surgical operation, an average of 1 hour)
- numbers of participants with postoperative complications(from operation to discharging, an average of 1 week)
研究者
Jun Liu
Professor
Guangzhou Institute of Respiratory Disease