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Clinical Trial of Thoracoscopic Lobecotmy Under Spontaneous Ventilating Anesthesia

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ClinicalTrials.gov Identifier: NCT03432637
Recruitment Status : Recruiting
First Posted : February 14, 2018
Last Update Posted : February 26, 2018
Sponsor:
Collaborators:
Shenzhen People's Hospital
Tongji Hospital
Information provided by (Responsible Party):
Jun Liu, Guangzhou Institute of Respiratory Disease

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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Procedure: spontaneous ventilation Procedure: intubated anesthesia with single-lung mechanical ventilation Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Thoracoscopic Lobecotmy Under Spontaneous Ventilating Anesthesia or Intubated Anesthesia: A Prospective, Multicentre, Open-label, Randomized Control Trial
Estimated Study Start Date : March 5, 2018
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SV
undergoing thoracoscopic lobectomy under spontaneous ventilation (SV)
Procedure: spontaneous ventilation
thoracoscopic lobectomy under spontaneous ventilation

Active Comparator: SLV
undergoing thoracoscopic lobectomy under intubated anesthesia with single-lung mechanical ventilation(SLV)
Procedure: intubated anesthesia with single-lung mechanical ventilation
undergoing thoracoscopic lobectomy under intubated anesthesia with single-lung mechanical ventilation




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.


Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03432637


Contacts
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Contact: Fei Cui, Ph.D, M.D. 08618902301212 ext 08602083062817 cuidavil@hotmail.com

Locations
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China, Guangdong
the First Affiliated Hospital of Guangzhou Medical College Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Fei Cui, MD.,PhD    08618902301212    4641121@qq.com   
Fei Cui, Ph.D, M.D. Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Fei Cui, Ph.D, M.D.    08618902301212 ext 08602083062817    cuidavil@hotmail.com   
Contact: Jun Liu, Ph.D, M.D.    08602013808880646    liujun9707@tom.com   
Sponsors and Collaborators
Guangzhou Institute of Respiratory Disease
Shenzhen People's Hospital
Tongji Hospital
Investigators
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Study Chair: Jun Liu, Ph.D, M.D. The First Affiliated Hospital of Guangzhou Medical University

Publications:

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Responsible Party: Jun Liu, Principal Investigator, Guangzhou Institute of Respiratory Disease
ClinicalTrials.gov Identifier: NCT03432637    
Other Study ID Numbers: SVA-NSCLC
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jun Liu, Guangzhou Institute of Respiratory Disease:
Complications, Postoperative/Perioperative
video assisted thoracic surgery
non-intubated anaesthesia
Additional relevant MeSH terms:
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Anesthetics
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Central Nervous System Depressants
Physiological Effects of Drugs