Non Small Cell Lung Cancer
Conditions
Keywords
Complications, Postoperative/Perioperative, video assisted thoracic surgery, non-intubated anaesthesia
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.
Interventions
PROCEDUREspontaneous ventilation
thoracoscopic lobectomy under spontaneous ventilation
PROCEDUREintubated anesthesia with single-lung mechanical ventilation
undergoing thoracoscopic lobectomy under intubated anesthesia with single-lung mechanical ventilation
Sponsors
Shenzhen People's Hospital
Tongji Hospital
Guangzhou Institute of Respiratory Disease
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| numbers of participants with postoperative complications | from operation to discharging, an average of 1 week | 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 |
| numbers of participants with anesthesia conversion intraoperatively in spontaneous ventilation group | during the surgical operation, an average of 1 hour | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| the postoperative hospitalization time of every participant | through the postoperative hospitalization time, an average of 1 week | the postoperative time point of participants meeting the discharging criteria: body T°\<37.5℃, degree of blood oxygen saturation on room air\>95%, no complications requiring in-hospital treatment, full lung re-expansion after chest tube removal, and white blood cell count\<10×109/L |
Countries
China
Contacts
Primary ContactFei Cui, Ph.D, M.D.
Outcome results
None listed