Clinical Trial of Thoracoscopic Bullectomy Surgery Under Spontaneous Ventilating Anesthesia

Guangzhou Institute of Respiratory Disease

Status and phase: Unknown; Phase 3

Conditions: Postoperative Hospitalization Time; Complication, Postoperative; Stability During Surgical Operation

Treatments: Procedure: Thoracoscopic Bullectomy Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03016858

SVA-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 320 estimated patients

Sex: All

Ages: 16 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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320 participants in 2 patient groups

NIIASV

Experimental group

Description:

undergoing Thoracoscopic Bullectomy Surgery under nonintubated intravenous anesthesia with spontaneous ventilation(NIIASV)

Treatment:

Procedure: Thoracoscopic Bullectomy Surgery

IASLV

Active Comparator group

Description:

undergoing Thoracoscopic Bullectomy Surgery under intubated anesthesia with single-lung mechanical ventilation(IASLV)

Treatment:

Procedure: Thoracoscopic Bullectomy Surgery