Clinical Trial of Thoracoscopic Lobecotmy Under Spontaneous Ventilating Anesthesia
February 22, 2018 updated by: Jun Liu, Guangzhou Institute of Respiratory Disease
Thoracoscopic Lobecotmy Under Spontaneous Ventilating Anesthesia or Intubated Anesthesia: A Prospective, Multicentre, Open-label, Randomized Control Trial
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.
Study Overview
Status
Recruiting
Conditions
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.
Study Type
Interventional
Enrollment (Anticipated)
450
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Fei Cui, Ph.D, M.D.
- Phone Number: 08602083062817 08618902301212
- Email: cuidavil@hotmail.com
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510000
- Recruiting
- The First Affiliated Hospital of Guangzhou Medical College
-
Guangzhou, Guangdong, China, 510120
- Recruiting
- Fei Cui, Ph.D, M.D.
-
Contact:
- Fei Cui, Ph.D, M.D.
- Phone Number: 08602083062817 08618902301212
- Email: cuidavil@hotmail.com
-
Contact:
- Jun Liu, Ph.D, M.D.
- Phone Number: 08602013808880646
- Email: liujun9707@tom.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: SV
undergoing thoracoscopic lobectomy under spontaneous ventilation (SV)
|
thoracoscopic lobectomy under spontaneous ventilation
|
|
ACTIVE_COMPARATOR: SLV
undergoing thoracoscopic lobectomy under intubated anesthesia with single-lung mechanical ventilation(SLV)
|
undergoing thoracoscopic lobectomy under intubated anesthesia with single-lung mechanical ventilation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
numbers of participants with unstable vital signs, hypoxemia or hypercapnia intraoperatively
Time Frame: 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.
|
during the surgical operation, an average of 1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
numbers of participants with postoperative complications
Time Frame: 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
|
from operation to discharging, an average of 1 week
|
|
numbers of participants with anesthesia conversion intraoperatively in spontaneous ventilation group
Time Frame: 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.
|
during the surgical operation, an average of 1 hour
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the postoperative hospitalization time of every participant
Time Frame: 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
|
through the postoperative hospitalization time, an average of 1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Jun Liu, Ph.D, M.D., The First Affiliated Hospital of Guangzhou Medical University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
March 5, 2018
Primary Completion (ANTICIPATED)
March 31, 2019
Study Completion (ANTICIPATED)
March 31, 2024
Study Registration Dates
First Submitted
January 31, 2018
First Submitted That Met QC Criteria
February 12, 2018
First Posted (ACTUAL)
February 14, 2018
Study Record Updates
Last Update Posted (ACTUAL)
February 26, 2018
Last Update Submitted That Met QC Criteria
February 22, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SVA-NSCLC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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