Thoracoscopic Lobecotmy Under Spontaneous Ventilating Anesthesia or Intubated Anesthesia: A Prospective, Multicentre, Open-label, Randomized Control Trial
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Non Small Cell Lung Cancer
- Sponsor
- Guangzhou Institute of Respiratory Disease
- Enrollment
- 450
- Locations
- 2
- Primary Endpoint
- numbers of participants with unstable vital signs, hypoxemia or hypercapnia intraoperatively
- Last Updated
- 8 years ago
Overview
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 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.
Investigators
Jun Liu
Principal Investigator
Guangzhou Institute of Respiratory Disease
Eligibility Criteria
Inclusion Criteria
- •volunteering to participate in clinical trials and having the ability of responsibility can be signed informed consent.
- •18-70 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 situation
Outcomes
Primary Outcomes
numbers of participants with unstable vital signs, hypoxemia or hypercapnia intraoperatively
Time Frame: 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.
Secondary Outcomes
- numbers of participants with postoperative complications(from operation to discharging, an average of 1 week)
- numbers of participants with anesthesia conversion intraoperatively in spontaneous ventilation group(during the surgical operation, an average of 1 hour)