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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
450
thoracoscopic lobectomy under spontaneous ventilation
undergoing thoracoscopic lobectomy under intubated anesthesia with single-lung mechanical ventilation
the First Affiliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong, China
RECRUITINGFei Cui, Ph.D, M.D.
Guangzhou, Guangdong, China
RECRUITINGnumbers of participants with unstable vital signs, hypoxemia or hypercapnia intraoperatively
the numbers of participants with unstable vital signs or hypoxemia/hypercapnia will be reported. The vital signs will be monitored through the whole surgical operation(including heart rating in beat per minute, temperature in degree Celsius, respiratory in breaths per minute and blood pressure in oxygen in millimetres of mercury ), and blood gas analysis((including partial pressure of oxygen in millimetres of mercury, partial pressure of carbon dioxide in millimetres of mercury, and so on) will be tested every 30 mins during the operation.
Time frame: during the surgical operation, an average of 1 hour
numbers of participants with postoperative complications
The numbers of participants with postoperative complications will be reported. The postoperative complications include postoperative respiratory complications(e.g., air leaks, lung infections, atelectasis, and bronchospasm and respiratory failure), postoperative cardiovascular complications(e.g., arrhythmias, myocardial infarction, cardiac failure) , intubated related complications(e.g., hoarseness, sore throat, and irritating cough), and other undefined complications
Time frame: from operation to discharging, an average of 1 week
numbers of participants with anesthesia conversion intraoperatively in spontaneous ventilation group
The numbers of participants undergoing conversion from nonintubated spontaneous ventilation anaesthesia to intubated anaesthesia in nonintubated group will be reported because of hypoxemia, carbohemia, bleeding or other undefined reasons.
Time frame: during the surgical operation, an average of 1 hour
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.