Clinical Trial of Thoracoscopic Bullectomy Surgery Under Spontaneous Ventilating Anesthesia

Phase 3

• Conditions: Postoperative Hospitalization Time; Complication, Postoperative; Stability During Surgical Operation
• Interventions: Procedure: Thoracoscopic Bullectomy Surgery

• Registration Number: NCT03016858
• Lead Sponsor: Guangzhou Institute of Respiratory Disease

Brief 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 multicenter randomized parallel controlled study was applied in this study to assess the efficacy and safety of thoracoscopic bullectomy surgery under intravenous anesthesia with spontaneous ventilation versus tracheal intubation general anesthesia.

Detailed Description

Intubated anesthesia with single lung mechanical ventilation (IASLV) 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, nonintubated strategies have been proposed in recent years.Encouraged by the satisfactory results with a preliminary experience of nonintubated VATS, the multicenter randomized parallel controlled study is established to comparatively analyze the outcome of patients undergoing either nonintubated intravenous anesthesia with spontaneous ventilation (NIIASV) or IASLV VATS thoracoscopic bullectomy surgery，especially in complication rate, safety during operation, muscle recovery after surgery, the difference the postoperative hospitalization time.

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-20
• Study First Submitted QC: 2017-01-08
• Study First Posted: 2017-01-11
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-27
• Last Update Posted: 2019-01-29
• Primary Completion: 2019-05
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

• volunteering to participate in clinical trials and having the ability of responsibility can be signed informed consent.
• 16-50 years old
• preoperative chest CT diagnosed with "localized lung bulla" and needing surgical treatment
• Eastern Cooperative Oncology Group(ECOG) score standard ≤ 1
• ASA（American Society of Anesthesiologists score） ≤ 2
• Heart ejection fraction( EF)≥ 50%

Exclusion Criteria

• refusing to participate in clinical trials
• A history of tuberculosis or other diseases could cause pleural adhesion or more pleural effusion
• BMI ≥ 25 kg/m^2
• other not suitable situations

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NIIASV	Thoracoscopic Bullectomy Surgery	undergoing Thoracoscopic Bullectomy Surgery under nonintubated intravenous anesthesia with spontaneous ventilation(NIIASV)
IASLV	Thoracoscopic Bullectomy Surgery	undergoing Thoracoscopic Bullectomy Surgery under intubated anesthesia with single-lung mechanical ventilation(IASLV)

Primary Outcome Measures

Name	Time	Method
numbers of participants with postoperative respiratory and cardiovascular complications	from operation to discharging, an average of 1 week	The numbers of participants with postoperative respiratory and cardiovascular 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

Secondary Outcome Measures

Name	Time	Method
numbers of participants with unstable vital signs, hypoxemia or hypercapnia intraoperatively	during the surgical operation, an average of 1 hour	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.
numbers of participants with anesthesia conversion intraoperatively in nonintubated group	during the surgical operation, an average of 1 hour	The numbers of participants undergoing conversion from nonintubated anaesthesia to intubated anaesthesia in nonintubated group will be reported because of hypoxemia, carbohemia, bleeding or other undefined reasons.
numbers of participants with postoperative complications	from operation to discharging, an average of 1 week	The numbers of participants with any postoperative complications will be reported.

Trial Locations

Locations (1)

the First Affiliated Hospital of Guangzhou Medical university; 🇨🇳 Guangzhou, Guangdong, China