Clinical Trial of Thoracoscopic Bullectomy Surgery Under Spontaneous Ventilating Anesthesia

NCT03016858 | Unknown Phase 3 DMC

• 1 other identifier: SVA-001
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Stability During Surgical Operation; Complication, Postoperative; Postoperative Hospitalization Time

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• numbers of participants with unstable vital signs, hypoxemia or hypercapnia intraoperatively

  during the surgical operation, an average of 1 hour

• numbers of participants with anesthesia conversion intraoperatively in nonintubated group

  during the surgical operation, an average of 1 hour

• numbers of participants with postoperative complications

  from operation to discharging, an average of 1 week

Other Outcomes (1)

• the postoperative hospitalization time of every participant

  through the postoperative hospitalization time, an average of 1 week)

Study Arms (2)

NIIASV

EXPERIMENTAL

undergoing Thoracoscopic Bullectomy Surgery under nonintubated intravenous anesthesia with spontaneous ventilation(NIIASV)

Procedure: Thoracoscopic Bullectomy Surgery

IASLV

ACTIVE COMPARATOR

undergoing Thoracoscopic Bullectomy Surgery under intubated anesthesia with single-lung mechanical ventilation(IASLV)

Procedure: Thoracoscopic Bullectomy Surgery

Interventions

Thoracoscopic Bullectomy Surgery PROCEDURE

undergoing the Thoracoscopic Bullectomy Surgery

Also known as: video-assisted thoracoscopic bulla resection

IASLV; NIIASV

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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 situations

Sponsors & Collaborators

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

Study Sites (1)

the First Affiliated Hospital of Guangzhou Medical university

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (11)

• 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

• 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

• 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

• 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

• Cui F, Xu K, Liang H, Liang W, Li J, Wang W, Liu H, Liu J, He J. Spontaneous ventilation versus mechanical ventilation during video-assisted thoracoscopic surgery for spontaneous pneumothorax: a study protocol for multicenter randomized controlled trial. J Thorac Dis. 2020 Apr;12(4):1570-1581. doi: 10.21037/jtd.2020.02.13.

  PMID: 32395294 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

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: Professor

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: January 11, 2017
• Study Start: December 1, 2016
• Primary Completion: May 1, 2019
• Study Completion: December 1, 2019
• Last Updated: January 29, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)