Clinical Trial of Thoracoscopic Bullectomy Surgery Under Spontaneous Ventilating Anesthesia

January 27, 2019 updated by: Jun Liu, Guangzhou Institute of Respiratory Disease

Multicenter Randomized Controlled Clinical Trial of Thoracoscopic Bullectomy Surgery Under Nonintubated Intravenous Anesthesia With Spontaneous Ventilation

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Intubated anesthesia with single lung mechanical ventilation (IASLV) 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, nonintubated strategies have been proposed in recent years.Encouraged by the satisfactory results with a preliminary experience of nonintubated VATS, the multicenter randomized parallel controlled study is established to comparatively analyze the outcome of patients undergoing either nonintubated intravenous anesthesia with spontaneous ventilation (NIIASV) or IASLV VATS thoracoscopic bullectomy surgery，especially in complication rate, safety during operation, muscle recovery after surgery, the difference the postoperative hospitalization time.

Study Type

Interventional

Enrollment (Anticipated)

320

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 Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • The First Affiliated Hospital of Guangzhou Medical University

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

16 years to 50 years (ADULT, CHILD)

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.
  • 16-50 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 situations

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: NIIASV
undergoing Thoracoscopic Bullectomy Surgery under nonintubated intravenous anesthesia with spontaneous ventilation(NIIASV)
Procedure: Thoracoscopic Bullectomy Surgery
undergoing the Thoracoscopic Bullectomy Surgery
Other Names:
  • video-assisted thoracoscopic bulla resection
ACTIVE_COMPARATOR: IASLV
undergoing Thoracoscopic Bullectomy Surgery under intubated anesthesia with single-lung mechanical ventilation(IASLV)
Procedure: Thoracoscopic Bullectomy Surgery
undergoing the Thoracoscopic Bullectomy Surgery
Other Names:
  • video-assisted thoracoscopic bulla resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
numbers of participants with postoperative respiratory and cardiovascular complications
Time Frame: from operation to discharging, an average of 1 week
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 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
numbers of participants with anesthesia conversion intraoperatively in nonintubated group
Time Frame: during the surgical operation, an average of 1 hour
The numbers of participants undergoing conversion from nonintubated 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
numbers of participants with postoperative complications
Time Frame: from operation to discharging, an average of 1 week
The numbers of participants with any postoperative complications will be reported.
from operation to discharging, an average of 1 week

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

First Affiliated Hospital, Sun Yat-Sen University
Nanfang Hospital of Southern Medical University
Taizhou Hospital
Jieyang People's Hospital
Shenzhen Third People's Hospital
Affiliated Hospital of Southwest Medical University
The Second Affiliated Hospital, South China University

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

December 1, 2016

Primary Completion (ANTICIPATED)

May 1, 2019

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

December 20, 2016

First Submitted That Met QC Criteria

January 8, 2017

First Posted (ESTIMATE)

January 11, 2017

Study Record Updates

Last Update Posted (ACTUAL)

January 29, 2019

Last Update Submitted That Met QC Criteria

January 27, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SVA-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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