NCT03432637

Clinical Trial of Thoracoscopic Lobecotmy Under Spontaneous Ventilating Anesthesia

Thoracoscopic Lobecotmy Under Spontaneous Ventilating Anesthesia or Intubated Anesthesia: A Prospective, Multicentre, Open-label, Randomized Control Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Guangzhou Institute of Respiratory Disease · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
PROCEDURE	spontaneous ventilation	thoracoscopic lobectomy under spontaneous ventilation
PROCEDURE	intubated anesthesia with single-lung mechanical ventilation	undergoing thoracoscopic lobectomy under intubated anesthesia with single-lung mechanical ventilation

Timeline

• Start date: 2018-03-05
• Primary completion: 2019-03-31
• Completion: 2024-03-31
• First posted: 2018-02-14
• Last updated: 2018-02-26

Locations

2 sites across 1 country: China