Clinical Trial of Thoracoscopic Lobecotmy Under Spontaneous Ventilating Anesthesia

Guangzhou Institute of Respiratory Disease

Status and phase: Unknown; Phase 3

Conditions: Non Small Cell Lung Cancer

Treatments: Procedure: intubated anesthesia with single-lung mechanical ventilation; Procedure: spontaneous ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT03432637

SVA-NSCLC

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 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.

Full 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.

Enrollment: 450 estimated patients

Sex: All

Ages: 18 to 70 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.
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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450 participants in 2 patient groups

SV

Experimental group

Description:

undergoing thoracoscopic lobectomy under spontaneous ventilation (SV)

Treatment:

Procedure: spontaneous ventilation

SLV

Active Comparator group

Description:

undergoing thoracoscopic lobectomy under intubated anesthesia with single-lung mechanical ventilation(SLV)

Treatment:

Procedure: intubated anesthesia with single-lung mechanical ventilation