Non-intubated Versus Intubated Anesthesia for Thoracoscopic Sublobar Resection (NIVA-TSLR)

Guangzhou Medical University

Status: Not yet enrolling

Conditions: Lung Neoplasms; Pulmonary Nodules; Thoracic Surgery

Treatments: Device: Double-lumen Endotracheal Tube (DLT); Procedure: Conventional Intubated General Anesthesia; Device: Laryngeal Mask Airway (LMA); Procedure: Non-intubated Anesthesia; Drug: General Anesthesia With Neuromuscular Blockade; Drug: Intravenous Sedation/Anesthesia (Spontaneous Ventilation); Drug: Regional Nerve Block (Paravertebral/Intercostal Block)

Study type: Interventional

Funder types: Other

Identifiers

NCT07395375

NIT-Sublobar-VATS

Details and patient eligibility

About

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.

Enrollment: 1,600 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Cardiovascular: NYHA class ≥ III, unstable angina, acute myocardial infarction within 3 months, or severe arrhythmia requiring medication.
2. 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).
3. Airway Risk: Modified Mallampati score ≥ 3, mouth opening < 3 cm, or other predictors of difficult airway management.
4. Radiological: Preoperative CT suggesting extensive pleural adhesion, moderate or large pleural effusion, or mediastinal lymph nodes > 1.5 cm short axis.
5. Contraindications to Regional Anesthesia: Infection/tumor at the block site, patient refusal, or allergy to local anesthetics.
6. Coagulopathy: Platelet count < 100×10⁹/L, INR > 1.5, or use of anticoagulants that cannot be safely discontinued perioperatively.
7. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,600 participants in 2 patient groups

Non-intubated Anesthesia Group

Experimental group

Description:

Patients randomized to this group will receive the experimental intervention, non-intubated spontaneous breathing anesthesia. The key components include: Airway Management: A laryngeal mask airway will be used instead of an endotracheal tube. Anesthesia Technique: Intravenous sedation will be administered to maintain spontaneous breathing, combined with regional nerve blocks (e.g., paravertebral or intercostal block) for analgesia. Goal: This approach aims to avoid the potential trauma and lung injury associated with double-lumen tube intubation and mechanical ventilation. A predefined set of safety criteria for conversion to intubated anesthesia (e.g., low oxygen levels, excessive carbon dioxide buildup) will be strictly followed during the procedure.

Treatment:

Drug: Regional Nerve Block (Paravertebral/Intercostal Block)

Drug: Intravenous Sedation/Anesthesia (Spontaneous Ventilation)

Procedure: Non-intubated Anesthesia

Device: Laryngeal Mask Airway (LMA)

Conventional Anesthesia Group

Active Comparator group

Description:

Patients randomized to this group will receive the current standard of care for thoracoscopic lung surgery, which is conventional intubated general anesthesia. The intervention consists of: Airway Management: Double-lumen endobronchial tube intubation to achieve one-lung ventilation. Anesthesia Technique: Standard general anesthesia with muscle relaxation and controlled mechanical ventilation. This approach represents the well-established, traditional method against which the experimental non-intubated anesthesia is being compared.

Treatment:

Drug: General Anesthesia With Neuromuscular Blockade

Procedure: Conventional Intubated General Anesthesia

Device: Double-lumen Endotracheal Tube (DLT)