Pulmonary Nodules, Lung Neoplasms, Thoracic Surgery
Conditions
Keywords
Non-intubated Thoracic Surgery, Lung Sublobar Resection, Video-Assisted Thoracoscopic Surgery, Enhanced Recovery After Surgery, Randomized Controlled Trial
Brief summary
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
PROCEDURENon-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.
PROCEDUREConventional 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.
Airway management using a laryngeal mask airway to maintain spontaneous ventilation during thoracoscopic surgery.
DRUGIntravenous Sedation/Anesthesia (Spontaneous Ventilation)
Intravenous sedative/anesthetic agents administered to achieve adequate anesthesia while preserving spontaneous breathing.
DRUGRegional Nerve Block (Paravertebral/Intercostal Block)
Regional anesthesia with local anesthetic (e.g., paravertebral or intercostal block) for perioperative analgesia.
Double-lumen endotracheal tube used to achieve one-lung ventilation during general anesthesia.
DRUGGeneral Anesthesia With Neuromuscular Blockade
General anesthesia maintained with intravenous and/or inhalational agents with muscle relaxation for controlled mechanical ventilation.
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of composite perioperative complications | From anesthesia induction up to 30 days after surgery | This primary outcome measures the incidence of a composite of postoperative pulmonary complications (PPCs) within 30 days after surgery. The composite endpoint includes the occurrence of any one of the following predefined complications: pneumonia, respiratory failure, atelectasis requiring bronchoscopy, acute lung injury (ALI)/acute respiratory distress syndrome (ARDS), pulmonary embolism, bronchopleural fistula, pleural effusion requiring drainage, or pneumothorax requiring intervention. The assessment period begins at anesthesia induction and concludes 30 days post-surgery. |
| Postoperative recovery quality assessed by the QoR-15 score | At 24 hours after surgery | This primary outcome measures the quality of patient recovery at 24 hours after surgery using the validated Quality of Recovery-15 (QoR-15) questionnaire. The QoR-15 score encompasses 15 items across five dimensions: physical comfort (5 items), emotional state (4 items), physical independence (2 items), psychological support (2 items), and pain (2 items). Each item is scored on a scale from 0 to 10. The total score ranges from 0 (extremely poor quality of recovery) to 150 (excellent quality of recovery). A higher total score indicates a better postoperative recovery experience from the patient's perspective. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of postoperative hospital stay | From the day of surgery until the day of discharge, assessed up to 30 days. | The duration of hospitalization in days, calculated from the day of surgery to the day of meeting discharge criteria (e.g., adequate pain control with oral analgesics, no air leak, afebrile, able to ambulate independently). |
| Incidence of intraoperative conversion | During the surgical procedure (from anesthesia induction until skin closure). | The rate of conversion from non-intubated anesthesia to conventional intubated general anesthesia due to unacceptable surgical conditions (e.g., poor lung collapse, diaphragmatic movement) or patient safety concerns (e.g., hypoxemia, hypercapnia, hemodynamic instability). |
Countries
China
Contacts
CONTACTHengrui Liang, M.D.
Outcome results
None listed