Spontaneous Ventilation versus Mechanical Ventilation During Video-Assisted Thoracoscopic Surgery for Spontaneous Pneumothorax: A Multicenter Randomized Controlled Trial

Abstract

Background: Spontaneous ventilation VATS (SV-VATS) is reported to be associated with faster recovery and fewer complications than mechanical ventilation video-assisted thoracic surgery (MV-VATS). This study aimed to evaluate the effect of SV-VATS for patients with spontaneous pneumothorax. Methods: We performed a randomized controlled trial at 10 medical centers by recruiting primary pneumothorax patients undergoing SV-VATS and MV-VATS. Participants were randomly assigned (1:1), to receive non-intubated spontaneous ventilation (SV-VATS) or intubated mechanical one lung ventilation (MV-VATS). The primary outcome was the intraoperative surgery/anesthesia related accident rate, which was assessed according to incedences of intraoperative hypoxia, conversion to open surgery, conversion to intubation and other intraoperative adverse events that could happen in both groups. Other study outcomes included changes of vital signs, total analgesic dose, recovery time, post-operative complication rates, cost-effectiveness evaluation, etc. Findings: The trial began on Apr 10, 2017, and ended on Jan 03, 2019. During this time, 355 patients were assessed. After evaluation and randomization, 325 eligible patients were assigned to receive an SV-VATS (n=162) or MV-VATS (n=163) procedure. In the intention-to-treat analysis, there was no difference between the intraoperative accident rate of the SV-VATS (1.23%) and MV-VATS (1.23%) group (P=0.995). The SV-VATS group was associated with significantly decreased total dosage of both sufentanil (11.37 μg vs 20.92 μg; p<0.001) and remifentanil (269.78 μg vs 404.96 μg; p<0.001). SV-VATS was also associated with shorter extubation time (12.28 min vs 13.70 min; p<0.001) and post-anesthesia care unit (PACU) recovery time (25.43 min vs 30.67 min; p=0.003). SV-VATS significantly deceased the anesthesia cost compared with MV-VATS (2051.91 RMB VS.2754.71 RMB; P<0.001). Interpretation: SV-VATS for primary pneumothorax had a similar intraoperative surgery/anesthesia related accident rate compared with MV-VATS and can be an alternative when selecting anesthesia ventilation during operation. Trial Registration: This trial is registered with ClinicalTrials.gov, number NCT03016858. Funding Statement: Guangdong Association of Thoracic Diseases. Declaration of Interests: The authors stated: None. Ethics Approval Statement: The study protocol has been approved by the Research Ethics Committee of the First Affiliated Hospital of Guangzhou Medical university (SVA-001).