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
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- The First Affiliated Hospital of Guangzhou Medical University
- Enrollment
- 1,600
- Locations
- 1
- Primary Endpoint
- Postoperative recovery quality assessed by the QoR-15 score
Overview
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:
- 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.
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Non-intubated Anesthesia Group
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.
Intervention: Non-intubated Anesthesia (Procedure)
Non-intubated Anesthesia Group
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.
Intervention: Laryngeal Mask Airway (LMA) (Device)
Non-intubated Anesthesia Group
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.
Intervention: Intravenous Sedation/Anesthesia (Spontaneous Ventilation) (Drug)
Non-intubated Anesthesia Group
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.
Intervention: Regional Nerve Block (Paravertebral/Intercostal Block) (Drug)
Conventional Anesthesia Group
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.
Intervention: Conventional Intubated General Anesthesia (Procedure)
Conventional Anesthesia Group
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.
Intervention: Double-lumen Endotracheal Tube (DLT) (Device)
Conventional Anesthesia Group
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.
Intervention: General Anesthesia With Neuromuscular Blockade (Drug)
Outcomes
Primary Outcomes
Postoperative recovery quality assessed by the QoR-15 score
Time Frame: 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.
Incidence of composite perioperative complications
Time Frame: 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.
Secondary Outcomes
- Length of postoperative hospital stay(From the day of surgery until the day of discharge, assessed up to 30 days.)
- Incidence of intraoperative conversion(During the surgical procedure (from anesthesia induction until skin closure).)
Investigators
Jianxing He
Professor, Chief of Thoracic Surgery Department
The First Affiliated Hospital of Guangzhou Medical University