Clinical Trial of Thoracoscopic Lobecotmy Under Spontaneous Ventilating Anesthesia
Primary Purpose
Non Small Cell Lung Cancer
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
spontaneous ventilation
intubated anesthesia with single-lung mechanical ventilation
Sponsored by
About this trial
This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring Complications, Postoperative/Perioperative, video assisted thoracic surgery, non-intubated anaesthesia
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
Sites / Locations
- the First Affiliated Hospital of Guangzhou Medical CollegeRecruiting
- Fei Cui, Ph.D, M.D.Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SV
SLV
Arm Description
undergoing thoracoscopic lobectomy under spontaneous ventilation (SV)
undergoing thoracoscopic lobectomy under intubated anesthesia with single-lung mechanical ventilation(SLV)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
numbers of participants with postoperative complications
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
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.
Full Information
NCT ID
NCT03432637
First Posted
January 31, 2018
Last Updated
February 22, 2018
Sponsor
Guangzhou Institute of Respiratory Disease
Collaborators
Shenzhen People's Hospital, Tongji Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03432637
Brief Title
Clinical Trial of Thoracoscopic Lobecotmy Under Spontaneous Ventilating Anesthesia
Official Title
Thoracoscopic Lobecotmy Under Spontaneous Ventilating Anesthesia or Intubated Anesthesia: A Prospective, Multicentre, Open-label, Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Recruiting
Study Start Date
March 5, 2018 (Anticipated)
Primary Completion Date
March 31, 2019 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou Institute of Respiratory Disease
Collaborators
Shenzhen People's Hospital, Tongji Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
Keywords
Complications, Postoperative/Perioperative, video assisted thoracic surgery, non-intubated anaesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SV
Arm Type
Experimental
Arm Description
undergoing thoracoscopic lobectomy under spontaneous ventilation (SV)
Arm Title
SLV
Arm Type
Active Comparator
Arm Description
undergoing thoracoscopic lobectomy under intubated anesthesia with single-lung mechanical ventilation(SLV)
Intervention Type
Procedure
Intervention Name(s)
spontaneous ventilation
Intervention Description
thoracoscopic lobectomy under spontaneous ventilation
Intervention Type
Procedure
Intervention Name(s)
intubated anesthesia with single-lung mechanical ventilation
Intervention Description
undergoing thoracoscopic lobectomy under intubated anesthesia with single-lung mechanical ventilation
Primary Outcome Measure Information:
Title
numbers of participants with unstable vital signs, hypoxemia or hypercapnia intraoperatively
Description
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.
Time Frame
during the surgical operation, an average of 1 hour
Secondary Outcome Measure Information:
Title
numbers of participants with postoperative complications
Description
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
Time Frame
from operation to discharging, an average of 1 week
Title
numbers of participants with anesthesia conversion intraoperatively in spontaneous ventilation group
Description
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.
Time Frame
during the surgical operation, an average of 1 hour
Other Pre-specified Outcome Measures:
Title
the postoperative hospitalization time of every participant
Description
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
Time Frame
through the postoperative hospitalization time, an average of 1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fei Cui, Ph.D, M.D.
Phone
08618902301212
Ext
08602083062817
Email
cuidavil@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Liu, Ph.D, M.D.
Organizational Affiliation
The First Affiliated Hospital of Guangzhou Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
the First Affiliated Hospital of Guangzhou Medical College
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fei Cui, MD.,PhD
Phone
08618902301212
Email
4641121@qq.com
Facility Name
Fei Cui, Ph.D, M.D.
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fei Cui, Ph.D, M.D.
Phone
08618902301212
Ext
08602083062817
Email
cuidavil@hotmail.com
First Name & Middle Initial & Last Name & Degree
Jun Liu, Ph.D, M.D.
Phone
08602013808880646
Email
liujun9707@tom.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
27621880
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.
Results Reference
background
PubMed Identifier
27076956
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.
Results Reference
background
PubMed Identifier
27076955
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.
Results Reference
background
PubMed Identifier
26046043
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.
Results Reference
background
PubMed Identifier
25937782
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.
Results Reference
background
PubMed Identifier
28007874
Citation
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.
Results Reference
background
PubMed Identifier
27165771
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. doi: 10.1093/ejcts/ezw160. Epub 2016 May 10.
Results Reference
background
PubMed Identifier
28275463
Citation
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.
Results Reference
background
PubMed Identifier
22833817
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.
Results Reference
background
PubMed Identifier
27165732
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.
Results Reference
background
PubMed Identifier
24821259
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.
Results Reference
background
PubMed Identifier
21869676
Citation
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.
Results Reference
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Clinical Trial of Thoracoscopic Lobecotmy Under Spontaneous Ventilating Anesthesia
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