Non-intubated Versus Intubated Anesthesia for Thoracoscopic Sublobar Resection

Official title

A Multicenter, Randomized, Controlled Trial of Non-Intubated Spontaneous Breathing Anesthesia Versus Intubated Mechanical Ventilation Anesthesia in Thoracoscopic Sublobar Resection: A Stratified Analysis Study Focusing on Safety and Recovery Quality

Overview

This is a large clinical study that compares two different types of anesthesia for patients undergoing a specific kind of minimally invasive lung surgery (thoracoscopic sublobar resection) to remove small, early-stage lung nodules. The study aims to find out if a newer anesthesia method, known as "non-intubated anesthesia" (where patients breathe on their own with the help of a laryngeal mask airway and nerve blocks for pain control), is as safe as the traditional "intubated anesthesia" (which uses a breathing tube and a machine to breathe for the patient). The main goals of the study are, in order: 1. Safety First: To confirm that the non-intubated method does not lead to more lung complications within 30 days after surgery compared to the traditional method. 2. Effectiveness: If it is proven safe, the study will then check if patients receiving the non-intubated anesthesia have a better quality of recovery in the first 24 hours after surgery (e.g., less pain, fewer side effects like a sore throat, and a faster return to normal activities). Approximately 1600 patients from multiple hospitals will be randomly assigned (like flipping a coin) to receive one of the two anesthesia methods. Neither the patients nor the surgeons will be told which group the patient is in when assessing the main outcomes after surgery, to ensure the results are fair and unbiased. The results of this study will provide high-quality evidence to help doctors and patients choose the best and most comfortable anesthesia option for this type of lung surgery.

Interventions

• Procedure Non-intubated Anesthesia
  A novel anesthetic technique for thoracic surgery that avoids endotracheal intubation and mechanical ventilation. It typically involves intravenous sedation, the use of a laryngeal mask airway (LMA) for oxygenation, and regional nerve blocks (e.g., paravertebral block) for pain control. The key feature is the preservation of the patient's spontaneous breathing throughout the surgical procedure.
• Procedure Conventional Intubated General Anesthesia
  The current standard anesthetic technique for thoracoscopic surgery. It involves general anesthesia induced by intravenous agents, followed by the insertion of a double-lumen endotracheal tube to achieve one-lung ventilation. Anesthesia is maintained with inhalational or intravenous agents, and the patient's ventilation is fully controlled by a mechanical ventilator throughout the operation.
• Device Laryngeal Mask Airway (LMA)
  Airway management using a laryngeal mask airway to maintain spontaneous ventilation during thoracoscopic surgery.
• Drug Intravenous Sedation/Anesthesia (Spontaneous Ventilation)
  Intravenous sedative/anesthetic agents administered to achieve adequate anesthesia while preserving spontaneous breathing.
• Drug Regional Nerve Block (Paravertebral/Intercostal Block)
  Regional anesthesia with local anesthetic (e.g., paravertebral or intercostal block) for perioperative analgesia.
• Device Double-lumen Endotracheal Tube (DLT)
  Double-lumen endotracheal tube used to achieve one-lung ventilation during general anesthesia.
• Drug General Anesthesia With Neuromuscular Blockade
  General anesthesia maintained with intravenous and/or inhalational agents with muscle relaxation for controlled mechanical ventilation.

Primary outcome measures

• Incidence of composite perioperative complications [Time frame: From anesthesia induction up to 30 days after surgery]
• Postoperative recovery quality assessed by the QoR-15 score [Time frame: At 24 hours after surgery]

Secondary outcome measures (2)

• Length of postoperative hospital stay [Time frame: From the day of surgery until the day of discharge, assessed up to 30 days.]
• Incidence of intraoperative conversion [Time frame: During the surgical procedure (from anesthesia induction until skin closure).]

Eligibility criteria

Inclusion criteria

• Aged 18 to 80 years (inclusive).
• Scheduled for elective, uniportal or single utility port video-assisted thoracoscopic sublobar resection (wedge resection or simple anatomical segmentectomy).
• Preoperative CT diagnosis of a peripheral pulmonary nodule meeting: maximum diameter ≤ 2.0 cm and outer edge ≤ 2.0 cm from the visceral pleura.
• American Society of Anesthesiologists (ASA) physical status I or II.
• Preoperative pulmonary function: FEV1% ≥ 60% of predicted.
• Preoperative arterial blood gas analysis (room air): PaO₂ ≥ 80 mmHg and PaCO₂ ≤ 45 mmHg.
• Body Mass Index (BMI) between 18.0 and 28.0 kg/m².
• Able to understand the study and provide written informed consent.

Exclusion criteria

• Cardiovascular: NYHA class ≥ III, unstable angina, acute myocardial infarction within 3 months, or severe arrhythmia requiring medication.
• Respiratory: Severe COPD (GOLD 3 or 4), symptomatic interstitial lung disease, resting SpO₂ < 92% on room air, or severe pulmonary hypertension (estimated systolic PAP > 50 mmHg).
• Airway Risk: Modified Mallampati score ≥ 3, mouth opening < 3 cm, or other predictors of difficult airway management.
• Radiological: Preoperative CT suggesting extensive pleural adhesion, moderate or large pleural effusion, or mediastinal lymph nodes > 1.5 cm short axis.
• Contraindications to Regional Anesthesia: Infection/tumor at the block site, patient refusal, or allergy to local anesthetics.
• Coagulopathy: Platelet count < 100×10⁹/L, INR > 1.5, or use of anticoagulants that cannot be safely discontinued perioperatively.
• Other: Severe hepatic or renal dysfunction, previous ipsilateral thoracic surgery, pregnancy or lactation, active psychiatric or cognitive disorders, or participation in another conflicting clinical trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 1 center

• The First Affiliated Hospital of GZMU — Guangzhou

Publications

• Wen Y, Liang H, Qiu G, Liu Z, Liu J, Ying W, Liang W, He J. Non-intubated spontaneous ventilation in video-assisted thoracoscopic surgery: a meta-analysis. Eur J Cardiothorac Surg. 2020 Mar 1;57(3):428-437. doi: 10.1093/ejcts/ezz279. PMID 31725158
• Myles PS, Shulman MA, Reilly J, Kasza J, Romero L. Measurement of quality of recovery after surgery using the 15-item quality of recovery scale: a systematic review and meta-analysis. Br J Anaesth. 2022 Jun;128(6):1029-1039. doi: 10.1016/j.bja.2022.03.009. Epub 2022 Apr 14. PMID 35430086
• Liu J, Liang H, Cui F, Liu H, Zhu C, Liang W, He J; International Tubeless-Video-Assisted Thoracoscopic Surgery Collaboration. Spontaneous versus mechanical ventilation during video-assisted thoracoscopic surgery for spontaneous pneumothorax: A randomized trial. J Thorac Cardiovasc Surg. 2022 May;163(5):1702-1714.e7. doi: 10.1016/j.jtcvs.2021.01.093. Epub 2021 Feb 3. PMID 33785209
• Zhang Z, Feng H, Zhao H, Hu J, Liu L, Liu Y, Li X, Xu L, Li Y, Lu X, Fu X, Yang H, Liu D. Sublobar resection is associated with better perioperative outcomes in elderly patients with clinical stage I non-small cell lung cancer: a multicenter retrospective cohort study. J Thorac Dis. 2019 May;11(5):1838-1848. doi: 10.21037/jtd.2019.05.20. PMID 31285876

Identifiers

NCT: NCT07395375 · NIT-Sublobar-VATS

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗