Spontaneous ventilation versus mechanical ventilation during video-assisted thoracoscopic surgery for spontaneous pneumothorax: a study protocol for multicenter randomized controlled trial

摘要

Background: 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. Methods: 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. Discussion: 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. Trial registration: NCT03016858; pre-results.