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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-intubated Anesthesia Group | Experimental | 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. |
|
| Conventional Anesthesia Group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-intubated Anesthesia | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of composite perioperative complications | 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. | From anesthesia induction up to 30 days after surgery |
| Postoperative recovery quality assessed by the QoR-15 score | 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. | At 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Length of postoperative hospital stay | 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). | From the day of surgery until the day of discharge, assessed up to 30 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hengrui Liang, M.D. | Contact | +862083062114 | liang_hengrui@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of GZMU | Guangzhou | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31725158 | Result | 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. | |
| 35430086 | Result | 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. |
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De-identified individual participant data (IPD) that underlie the results reported in the primary and secondary outcomes of this study will be shared. This includes demographic data, perioperative parameters, and all assessed outcome measures.
The IPD and supporting documents will become available 6 months after the publication of the primary study results (the main manuscript). The data will be accessible for a period of 5 years.
Researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal may request access. Proposals should be directed to the corresponding author via email. Data requestors will need to sign a data access/use agreement. The shared data will be available for analyses aimed at replicating the study results, conducting secondary analyses, or performing meta-analyses.
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|
| Conventional Intubated General Anesthesia | Procedure | 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. |
|
| Laryngeal Mask Airway (LMA) | Device | Airway management using a laryngeal mask airway to maintain spontaneous ventilation during thoracoscopic surgery. |
|
| Intravenous Sedation/Anesthesia (Spontaneous Ventilation) | Drug | Intravenous sedative/anesthetic agents administered to achieve adequate anesthesia while preserving spontaneous breathing. |
|
| Regional Nerve Block (Paravertebral/Intercostal Block) | Drug | Regional anesthesia with local anesthetic (e.g., paravertebral or intercostal block) for perioperative analgesia. |
|
| Double-lumen Endotracheal Tube (DLT) | Device | Double-lumen endotracheal tube used to achieve one-lung ventilation during general anesthesia. |
|
| General Anesthesia With Neuromuscular Blockade | Drug | General anesthesia maintained with intravenous and/or inhalational agents with muscle relaxation for controlled mechanical ventilation. |
|
| Incidence of intraoperative conversion |
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). |
| During the surgical procedure (from anesthesia induction until skin closure). |
| 33785209 | Result | 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. |
| 31285876 | Result | 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. |
| ID | Term |
|---|---|
| D055613 | Multiple Pulmonary Nodules |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D017214 | Laryngeal Masks |
| D000758 | Anesthesia |
| D000768 | Anesthesia, General |
| D019148 | Neuromuscular Blockade |
| ID | Term |
|---|---|
| D007442 | Intubation, Intratracheal |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D007440 | Intubation |
| D008919 | Investigative Techniques |
| D008397 | Masks |
| D011482 | Protective Devices |
| D004864 | Equipment and Supplies |
| D000067393 | Personal Protective Equipment |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D000760 | Anesthesia and Analgesia |
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