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

Abstract

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.

Keywords: Spontaneous ventilation; randomized controlled trial; spontaneous pneumothorax; video-assisted thoracoscopic surgery (VATS).

Conflict of interest statement

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at http://dx.doi.org/10.21037/jtd.2020.02.13). JH serves as an unpaid Editor-in-Chief of Journal of Thoracic Disease. WL serves as an unpaid editorial board member of Journal of Thoracic Disease from Dec 2015 to Dec 2021. The other authors have no conflicts of interest to declare.

2020 Journal of Thoracic Disease. All rights reserved.

Figures

Figure 1

Schematic outline of the trial design. CT, computed tomography; ECOG, Eastern Cooperative Oncology Group score standard; ASA, American Society of Anesthesiologists score; BMI, body mass index. MV-VATS, mechanical ventilation VATS; SV-VATS, spontaneous ventilation VATS.