Clinical Trial of Thoracoscopic Lobecotmy Under Spontaneous Ventilating Anesthesia

NCT03432637 | Unknown Phase 3 DMC

• 1 other identifier: SVA-NSCLC
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 2

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.

Conditions

Non Small Cell Lung Cancer

Keywords

Complications, Postoperative/Perioperative; video assisted thoracic surgery; non-intubated anaesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Other Outcomes (1)

• the postoperative hospitalization time of every participant

  through the postoperative hospitalization time, an average of 1 week

Study Arms (2)

SV

EXPERIMENTAL

undergoing thoracoscopic lobectomy under spontaneous ventilation (SV)

Procedure: spontaneous ventilation

SLV

ACTIVE COMPARATOR

undergoing thoracoscopic lobectomy under intubated anesthesia with single-lung mechanical ventilation(SLV)

Procedure: intubated anesthesia with single-lung mechanical ventilation

Interventions

spontaneous ventilation PROCEDURE

thoracoscopic lobectomy under spontaneous ventilation

SV

intubated anesthesia with single-lung mechanical ventilation PROCEDURE

undergoing thoracoscopic lobectomy under intubated anesthesia with single-lung mechanical ventilation

SLV

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• volunteering to participate in clinical trials and having the ability of responsibility can be signed informed consent.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangzhou Institute of Respiratory Disease: lead
• Shenzhen People's Hospital: collaborator
• Tongji Hospital: collaborator

Study Sites (2)

the First Affiliated Hospital of Guangzhou Medical College

Guangzhou, Guangdong, 510000, China

RECRUITING

Fei Cui, Ph.D, M.D.

Guangzhou, Guangdong, 510120, China

RECRUITING

Related Publications (12)

• 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.

  PMID: 27621880 BACKGROUND

• 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.

  PMID: 27076956 BACKGROUND

• 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.

  PMID: 27076955 BACKGROUND

• 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.

  PMID: 26046043 BACKGROUND

• 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.

  PMID: 25937782 BACKGROUND

• Li S, Jiang L, Ang KL, Chen H, Dong Q, Yang H, Li J, He J. New tubeless video-assisted thoracoscopic surgery for small pulmonary nodules. Eur J Cardiothorac Surg. 2017 Apr 1;51(4):689-693. doi: 10.1093/ejcts/ezw364.

  PMID: 28007874 BACKGROUND

• 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. doi: 10.1093/ejcts/ezw160. Epub 2016 May 10.

  PMID: 27165771 BACKGROUND

• Li J, Liu J, Hamblin L, Liu H, Liang L, Dong Q, He J. Simple to simplest: the tubeless technique. J Thorac Dis. 2017 Feb;9(2):222-224. doi: 10.21037/jtd.2017.02.55. No abstract available.

  PMID: 28275463 BACKGROUND

• 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.

  PMID: 22833817 BACKGROUND

• 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.

  PMID: 27165732 BACKGROUND

• 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.

  PMID: 24821259 BACKGROUND

• 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.

  PMID: 21869676 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jun Liu, Ph.D, M.D.

  The First Affiliated Hospital of Guangzhou Medical University

  STUDY CHAIR

Central Study Contacts

Fei Cui, Ph.D, M.D.

CONTACT

08618902301212; cuidavil@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: February 14, 2018
• Study Start: March 5, 2018
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2024
• Last Updated: February 26, 2018

Record last verified: 2018-02

Locations

CN (2)