Clinical trial NCT03016858: Clinical Trial of Thoracoscopic Bullectomy Surgery Under Spontaneous Ventilating Anesthesia
Official title: Multicenter Randomized Controlled Clinical Trial of Thoracoscopic Bullectomy Surgery Under Nonintubated Intravenous Anesthesia With Spontaneous Ventilation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Stability During Surgical Operation
Complication, Postoperative
Postoperative Hospitalization Time
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital, Sun Yat-Sen University
name: Taizhou Hospital
name: The Second Hospital University of South China
name: Affiliated Hospital of Southwest Medical University
name: Nanfang Hospital, Southern Medical University
name: Shenzhen Third People's Hospital
name: Jieyang People's Hospital
First posted: 2017-01-11
Enrollment: 320
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: numbers of participants with postoperative respiratory and cardiovascular complications
timeFrame: from operation to discharging, an average of 1 week
Secondary outcomes:
measure: numbers of participants with unstable vital signs, hypoxemia or hypercapnia intraoperatively
timeFrame: during the surgical operation, an average of 1 hour
measure: numbers of participants with anesthesia conversion intraoperatively in nonintubated group
timeFrame: during the surgical operation, an average of 1 hour
measure: numbers of participants with postoperative complications
timeFrame: from operation to discharging, an average of 1 week
Other outcomes:
measure: the postoperative hospitalization time of every participant
timeFrame: through the postoperative hospitalization time, an average of 1 week)
Locations:
city: Guangzhou
country: China
facility: the First Affiliated Hospital of Guangzhou Medical university
state: Guangdong
Study officials:
affiliation: The First Affiliated Hospital of Guangzhou Medical University
name: Jun Liu, Ph.D, M.D.
role: STUDY_CHAIR
References:
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