[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623341":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":58,"locations":64,"responsibleParty":80,"collaborators":31,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":86,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":31,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":106,"overallStatus":112,"whyStopped":31,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"The First Affiliated Hospital of Guangzhou Medical University","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Non-intubated Anesthesia Group","EXPERIMENTAL","Patients randomized to this group will receive the experimental intervention, non-intubated spontaneous breathing anesthesia. The key components include:\n\nAirway Management: A laryngeal mask airway will be used instead of an endotracheal tube.\n\nAnesthesia Technique: Intravenous sedation will be administered to maintain spontaneous breathing, combined with regional nerve blocks (e.g., paravertebral or intercostal block) for analgesia.\n\nGoal: This approach aims to avoid the potential trauma and lung injury associated with double-lumen tube intubation and mechanical ventilation.\n\nA 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.",[13,14,15,16],"Procedure: Non-intubated Anesthesia","Device: Laryngeal Mask Airway (LMA)","Drug: Intravenous Sedation\u002FAnesthesia (Spontaneous Ventilation)","Drug: Regional Nerve Block (Paravertebral\u002FIntercostal Block)",{"label":18,"type":19,"description":20,"interventionNames":21},"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:\n\nAirway Management: Double-lumen endobronchial tube intubation to achieve one-lung ventilation.\n\nAnesthesia Technique: Standard general anesthesia with muscle relaxation and controlled mechanical ventilation.\n\nThis approach represents the well-established, traditional method against which the experimental non-intubated anesthesia is being compared.",[22,23,24],"Procedure: Conventional Intubated General Anesthesia","Device: Double-lumen Endotracheal Tube (DLT)","Drug: General Anesthesia With Neuromuscular Blockade",[26,32,36,41,46,50,54],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"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.",[9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"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.",[18],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":31},"DEVICE","Laryngeal Mask Airway (LMA)","Airway management using a laryngeal mask airway to maintain spontaneous ventilation during thoracoscopic surgery.",[9],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":31},"DRUG","Intravenous Sedation\u002FAnesthesia (Spontaneous Ventilation)","Intravenous sedative\u002Fanesthetic agents administered to achieve adequate anesthesia while preserving spontaneous breathing.",[9],{"type":42,"name":47,"description":48,"armGroupLabels":49,"otherNames":31},"Regional Nerve Block (Paravertebral\u002FIntercostal Block)","Regional anesthesia with local anesthetic (e.g., paravertebral or intercostal block) for perioperative analgesia.",[9],{"type":37,"name":51,"description":52,"armGroupLabels":53,"otherNames":31},"Double-lumen Endotracheal Tube (DLT)","Double-lumen endotracheal tube used to achieve one-lung ventilation during general anesthesia.",[18],{"type":42,"name":55,"description":56,"armGroupLabels":57,"otherNames":31},"General Anesthesia With Neuromuscular Blockade","General anesthesia maintained with intravenous and\u002For inhalational agents with muscle relaxation for controlled mechanical ventilation.",[18],[59],{"name":60,"role":61,"phone":62,"phoneExt":31,"email":63},"Hengrui Liang, M.D.","CONTACT","+862083062114","liang_hengrui@163.com",[65],{"facility":66,"status":31,"city":67,"state":31,"zip":31,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"The First Affiliated Hospital of GZMU","Guangzhou","China","CN",{"type":71,"coordinates":72},"Point",[73,74],113.25,23.11667,{"lat":74,"lon":73},[77],{"name":78,"role":61,"phone":79,"phoneExt":31,"email":63},"hengrui liang","86+020-83062807",{"type":81,"investigatorFullName":82,"investigatorTitle":83,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Jianxing He","Professor, Chief of Thoracic Surgery Department","100623341","non-intubated-versus-intubated-anesthesia-for-thoracoscopic-sublobar-resection-100623341",false,"NCT07395375","Non-intubated Versus Intubated Anesthesia for Thoracoscopic Sublobar Resection","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","NIVA-TSLR","Inclusion Criteria:\n\n1. Aged 18 to 80 years (inclusive).\n2. Scheduled for elective, uniportal or single utility port video-assisted thoracoscopic sublobar resection (wedge resection or simple anatomical segmentectomy).\n3. Preoperative CT diagnosis of a peripheral pulmonary nodule meeting: maximum diameter ≤ 2.0 cm and outer edge ≤ 2.0 cm from the visceral pleura.\n4. American Society of Anesthesiologists (ASA) physical status I or II.\n5. Preoperative pulmonary function: FEV1% ≥ 60% of predicted.\n6. Preoperative arterial blood gas analysis (room air): PaO₂ ≥ 80 mmHg and PaCO₂ ≤ 45 mmHg.\n7. Body Mass Index (BMI) between 18.0 and 28.0 kg\u002Fm².\n8. Able to understand the study and provide written informed consent.\n\nExclusion Criteria:\n\n1. Cardiovascular: NYHA class ≥ III, unstable angina, acute myocardial infarction within 3 months, or severe arrhythmia requiring medication.\n2. Respiratory: Severe COPD (GOLD 3 or 4), symptomatic interstitial lung disease, resting SpO₂ \\\u003C 92% on room air, or severe pulmonary hypertension (estimated systolic PAP \\> 50 mmHg).\n3. Airway Risk: Modified Mallampati score ≥ 3, mouth opening \\\u003C 3 cm, or other predictors of difficult airway management.\n4. Radiological: Preoperative CT suggesting extensive pleural adhesion, moderate or large pleural effusion, or mediastinal lymph nodes \\> 1.5 cm short axis.\n5. Contraindications to Regional Anesthesia: Infection\u002Ftumor at the block site, patient refusal, or allergy to local anesthetics.\n6. Coagulopathy: Platelet count \\\u003C 100×10⁹\u002FL, INR \\> 1.5, or use of anticoagulants that cannot be safely discontinued perioperatively.\n7. 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.","ALL","18 Years","80 Years",{"count":96,"type":97},1600,"ESTIMATED","INTERVENTIONAL",[100],"NA","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.\n\nThe 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).\n\nThe main goals of the study are, in order:\n\n1. 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.\n2. 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).\n\nApproximately 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.\n\nThe 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.",[103,104,105],"Pulmonary Nodules","Lung Neoplasms","Thoracic Surgery",[107,108,109,110,111],"Non-intubated Thoracic Surgery","Lung Sublobar Resection","Video-Assisted Thoracoscopic Surgery","Enhanced Recovery After Surgery","Randomized Controlled Trial","NOT_YET_RECRUITING","2026-02-06",{"date":115,"type":116},"2026-02-09","ACTUAL",{"date":118,"type":97},"2026-03-01",{"date":120,"type":97},"2027-08-01",{"name":5,"class":6},1]