Thoracoscopic Lobecotmy Under Spontaneous Ventilating Anesthesia or Intubated Anesthesia: A Prospective, Multicentre, Open-label, Randomized Control Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- numbers of participants with unstable vital signs, hypoxemia or hypercapnia intraoperatively
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 prospective, multicentre, randomized controlled clinical study was applied in this study to assess the feasibility and safety of thoracoscopic lobectomy under spontaneous ventilation versus intubated single lung mechanical ventilation.
详细描述
Intubated anesthesia with single lung mechanical ventilation (SLV) 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, spontaneous ventilation strategies have been proposed in recent years.Encouraged by the satisfactory results with a preliminary experience of spontaneous ventilated VATS, the multicentre randomized controlled clinical controled study is established to comparatively analyze the outcome of patients undergoing either nonintubated intravenous anesthesia with spontaneous ventilation (SV) or SLV VATS lobectomy, especially in safety during operation, lymph nodes resection, complication rate, 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
- 18 Years 至 70 Years（Adult, Older 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.
- •18-70 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 situation
研究组 & 干预措施
SV
undergoing thoracoscopic lobectomy under spontaneous ventilation (SV)
干预措施: spontaneous ventilation (Procedure)
SLV
undergoing thoracoscopic lobectomy under intubated anesthesia with single-lung mechanical ventilation(SLV)
干预措施: intubated anesthesia with single-lung mechanical ventilation (Procedure)
结局指标
主要结局
numbers of participants with unstable vital signs, hypoxemia or hypercapnia intraoperatively
时间窗: during the surgical operation, an average of 1 hour
the numbers of participants with unstable vital signs or hypoxemia/hypercapnia will be reported. The vital signs will be monitored through the whole surgical operation(including heart rating in beat per minute, temperature in degree Celsius, respiratory in breaths per minute and blood pressure in oxygen in millimetres of mercury ), and blood gas analysis((including partial pressure of oxygen in millimetres of mercury, partial pressure of carbon dioxide in millimetres of mercury, and so on) will be tested every 30 mins during the operation.
次要结局
- numbers of participants with postoperative complications(from operation to discharging, an average of 1 week)
- numbers of participants with anesthesia conversion intraoperatively in spontaneous ventilation group(during the surgical operation, an average of 1 hour)
研究者
Jun Liu
Principal Investigator
Guangzhou Institute of Respiratory Disease