Cui Fei, Xu Ke, Liang Hengrui, Liang Wenhua, Li Jingpei, Wang Wei, Liu Hui, Liu Jun, He Jianxing
Department of Thoracic Surgery, First Affiliated Hospital of Guangzhou Medical University, National Respiratory Disease Clinical Research Center, Guangzhou 510120, China.
Department of Anesthesia, First Affiliated Hospital of Guangzhou Medical University, Guangzhou 510120, China.
J Thorac Dis. 2020 Apr;12(4):1570-1581. doi: 10.21037/jtd.2020.02.13.
With the evolution and adoption of video-assisted thoracoscopic surgery (VATS), options for anesthesia control have also seen major developments. Intubated anesthesia with single lung mechanical ventilation VATS (MV-VATS) is considered the standard of care in VATS. However, this type of ventilation strategy 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, non-intubated spontaneous ventilation VATS (SV-VATS) strategies have been proposed in recent years and widely applied.
We established a two-arm parallel multicenter randomized controlled trial for comparative analysis of the outcomes of patients undergoing either SV-VATS or MV-VATS for spontaneous pneumothorax. Outcomes of interest include safety during operation, total analgesic dose, recovery time, postoperative complication rates, postoperative pain score, length of hospitalization, inflammation index, medical cost, etc. The recruitment target is 316 patients. Patients will be eligible if their chest CT is diagnosed with "localized lung bullae" and need VATS resection. Patients will be randomized into the SV-VATS (test group) or MV-VATS (control group) after signing informed consent and surgical anesthesia evaluation.
This protocol has been approved by the Research Ethics Committee of the First Affiliated Hospital of Guangzhou Medical university. Results will be presented at national and international meetings and conferences and published in peer-reviewed journals. We will also disseminate the main results to all participants in a letter. Non-intubated SV-VATS offered a more individual choice of anesthetics and surgical method for spontaneous pneumothorax patients.
NCT03016858; pre-results.
随着电视辅助胸腔镜手术（VATS）的发展与应用，麻醉控制方案也有了重大进展。单肺机械通气VATS（MV-VATS）的插管麻醉被认为是VATS的标准治疗方法。然而，这种通气策略会带来一些不良反应，可能引发并发症并增加整体手术风险。为避免与插管麻醉相关的不良反应，近年来已提出并广泛应用非插管自主通气VATS（SV-VATS）策略。
我们开展了一项双臂平行多中心随机对照试验，以比较接受SV-VATS或MV-VATS治疗自发性气胸患者的结局。感兴趣的结局包括手术期间的安全性、总镇痛剂量、恢复时间、术后并发症发生率、术后疼痛评分、住院时间、炎症指标、医疗费用等。招募目标为316例患者。胸部CT诊断为“局限性肺大疱”且需要VATS切除的患者符合入选条件。签署知情同意书并经过手术麻醉评估后，患者将被随机分为SV-VATS组（试验组）或MV-VATS组（对照组）。
本方案已获得广州医科大学附属第一医院研究伦理委员会的批准。研究结果将在国内和国际会议上展示，并发表在同行评审期刊上。我们还将以信件形式向所有参与者传达主要结果。非插管SV-VATS为自发性气胸患者提供了更个性化的麻醉和手术方法选择。
NCT03016858；预结果。
