Clinical Trial of Thoracoscopic Bullectomy Surgery Under Spontaneous Ventilating Anesthesia

Complication, Postoperative Clinical Trial

Official title:

Multicenter Randomized Controlled Clinical Trial of Thoracoscopic Bullectomy Surgery Under Nonintubated Intravenous Anesthesia With Spontaneous Ventilation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03016858
• Other study ID #: SVA-001
• Status: Recruiting
• Phase: Phase 3
• Start date: December 2016
• Est. completion date: December 2019

Study information

• Verified date: January 2019
• Source: Guangzhou Institute of Respiratory Disease
• Contact: Fei Cui, Ph.D, M.D.
• Phone: 08618902301212
• Email: cuidavil[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: December 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Complication, Postoperative
• Postoperative Complications
• Postoperative Hospitalization Time
• Stability During Surgical Operation

Intervention

Procedure:
• Thoracoscopic Bullectomy Surgery
undergoing the Thoracoscopic Bullectomy Surgery

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Guangzhou Medical university	Guangzhou	Guangdong

Sponsors (8)

Lead Sponsor	Collaborator
Guangzhou Institute of Respiratory Disease	Affiliated Hospital of Southwest Medical University, First Affiliated Hospital, Sun Yat-Sen University, Jieyang People's Hospital, Nanfang Hospital of Southern Medical University, Shenzhen Third People's Hospital, Taizhou Hospital, The Second Affiliated Hospital, South China University

Country where clinical trial is conducted

China, 

References & Publications (10)

Chen JS, Cheng YJ, Hung MH, Tseng YD, Chen KC, Lee YC. Nonintubated thoracoscopic lobectomy for lung cancer. Ann Surg. 2011 Dec;254(6):1038-43. doi: 10.1097/SLA.0b013e31822ed19b. — View Citation

Cui F, Liu J, Li S, Yin W, Xin X, Shao W, He J. Tubeless video-assisted thoracoscopic surgery (VATS) under non-intubated, intravenous anesthesia with spontaneous ventilation and no placement of chest tube postoperatively. J Thorac Dis. 2016 Aug;8(8):2226-32. doi: 10.21037/jtd.2016.08.02. — View Citation

Dong Q, Liang L, Li Y, Liu J, Yin W, Chen H, Xu X, Shao W, He J. Anesthesia with nontracheal intubation in thoracic surgery. J Thorac Dis. 2012 Apr 1;4(2):126-30. doi: 10.3978/j.issn.2072-1439.2012.03.10. — View Citation

Guo Z, Yin W, Zhang X, Xu X, Liu H, Shao W, Liu J, Chen H, He J. Primary spontaneous pneumothorax: simultaneous treatment by bilateral non-intubated videothoracoscopy. Interact Cardiovasc Thorac Surg. 2016 Aug;23(2):196-201. doi: 10.1093/icvts/ivw123. Epub 2016 May 10. — View Citation

Li S, Cui F, Liu J, Xu X, Shao W, Yin W, Chen H, He J. Nonintubated uniportal video-assisted thoracoscopic surgery for primary spontaneous pneumothorax. Chin J Cancer Res. 2015 Apr;27(2):197-202. doi: 10.3978/j.issn.1000-9604.2015.03.01. — View Citation

Li S, Liu J, He J, Dong Q, Liang L, Cui F, Pan H, He J. Video-assisted transthoracic surgery resection of a tracheal mass and reconstruction of trachea under non-intubated anesthesia with spontaneous breathing. J Thorac Dis. 2016 Mar;8(3):575-85. doi: 10.21037/jtd.2016.01.62. — View Citation

Liu J, Cui F, He J. Non-intubated video-assisted thoracoscopic surgery anatomical resections: a new perspective for treatment of lung cancer. Ann Transl Med. 2015 May;3(8):102. doi: 10.3978/j.issn.2305-5839.2015.04.18. Review. — View Citation

Liu J, Cui F, Li S, Chen H, Shao W, Liang L, Yin W, Lin Y, He J. Nonintubated video-assisted thoracoscopic surgery under epidural anesthesia compared with conventional anesthetic option: a randomized control study. Surg Innov. 2015 Apr;22(2):123-30. doi: 10.1177/1553350614531662. Epub 2014 May 12. — View Citation

Liu J, Cui F, Pompeo E, Gonzalez-Rivas D, Chen H, Yin W, Shao W, Li S, Pan H, Shen J, Hamblin L, He J. The impact of non-intubated versus intubated anaesthesia on early outcomes of video-assisted thoracoscopic anatomical resection in non-small-cell lung cancer: a propensity score matching analysis. Eur J Cardiothorac Surg. 2016 Nov;50(5):920-925. Epub 2016 May 10. — View Citation

Peng G, Cui F, Ang KL, Zhang X, Yin W, Shao W, Dong Q, Liang L, He J. Non-intubated combined with video-assisted thoracoscopic in carinal reconstruction. J Thorac Dis. 2016 Mar;8(3):586-93. doi: 10.21037/jtd.2016.01.58. Erratum in: J Thorac Dis. 2016 Jul;8(7):E641. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	the postoperative hospitalization time of every participant	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.	through the postoperative hospitalization time, an average of 1 week)
Primary	numbers of participants with postoperative respiratory and cardiovascular complications	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	from operation to discharging, an average of 1 week
Secondary	numbers 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.	during the surgical operation, an average of 1 hour
Secondary	numbers of participants with anesthesia conversion intraoperatively in nonintubated group	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.	during the surgical operation, an average of 1 hour
Secondary	numbers of participants with postoperative complications	The numbers of participants with any postoperative complications will be reported.	from operation to discharging, an average of 1 week