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

Intervention / Treatment

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

Study Locations

  • China
    • 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:
        • Contact:

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)
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

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.

Sponsor

Guangzhou Institute of Respiratory Disease

Collaborators

Tongji Hospital
Shenzhen People's Hospital

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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