[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651273":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":37,"locations":43,"responsibleParty":59,"collaborators":27,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":27,"enrollmentInfo":73,"targetDuration":27,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":45,"whyStopped":27,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"The First Affiliated Hospital of Guangzhou Medical University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Non-Intubated Spontaneous Ventilation Anesthesia Group","EXPERIMENTAL","Participants assigned to this group will receive non-intubated spontaneous ventilation anesthesia supported by a supraglottic airway during isolated orthotopic heart transplantation. Spontaneous breathing will be preserved or restored as early as clinically feasible. Participants will receive standardized perioperative heart transplantation care, and the supraglottic airway may be removed in the operating room when predefined clinical criteria are met.",[13,14],"Procedure: Non-Intubated Spontaneous Ventilation Anesthesia","Drug: Standardized Perioperative Anesthetic and Analgesic Medication Regimen",{"label":16,"type":17,"description":18,"interventionNames":19},"Conventional Anesthesia Group","ACTIVE_COMPARATOR","Participants assigned to this group will receive conventional general anesthesia with endotracheal intubation and mechanical ventilation during isolated orthotopic heart transplantation. Ventilation will follow lung-protective principles and standardized heart transplantation anesthesia practices. After surgery, participants will be assessed for ventilator weaning and extubation according to their respiratory function, hemodynamic status, consciousness, bleeding, and graft function. Respiratory or circulatory support will be escalated whenever clinically necessary. Participants will receive the same standardized perioperative heart transplantation care as the experimental group.",[20,14],"Procedure: Conventional Anesthesia",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"PROCEDURE","Non-Intubated Spontaneous Ventilation Anesthesia","A standardized perioperative anesthesia strategy using a supraglottic airway without routine endotracheal intubation, with early restoration of spontaneous breathing when clinically feasible. Airway management, ventilation, and perioperative care will follow predefined study procedures. Endotracheal intubation or escalation of respiratory or circulatory support will be performed whenever clinically necessary for patient safety.",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Conventional Anesthesia","A standardized perioperative anesthesia strategy using endotracheal intubation and lung-protective mechanical ventilation during cardiac surgery with cardiopulmonary bypass. Airway management, ventilation, and perioperative care will follow predefined study procedures. Extubation will be performed when predefined physiologic criteria are met, and respiratory or circulatory support will be escalated whenever clinically necessary for patient safety.",[16],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":27},"DRUG","Standardized Perioperative Anesthetic and Analgesic Medication Regimen","Anesthesia maintenance will consist of continuous infusions of remifentanil and dexmedetomidine combined with target-controlled infusion of propofol. Sufentanil and sevoflurane may be administered when clinically indicated. Additional rocuronium may be administered as needed to facilitate surgical conditions.",[16,9],[38],{"name":39,"role":40,"phone":41,"phoneExt":27,"email":42},"Haoxiang Yuan","CONTACT","+8615692028041","2024390294@gzhmu.edu.cn",[44],{"facility":5,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","Guangzhou","Guangdong","450051","China","CN",{"type":52,"coordinates":53},"Point",[54,55],113.25,23.11667,{"lat":55,"lon":54},[58],{"name":39,"role":40,"phone":41,"phoneExt":27,"email":42},{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"PRINCIPAL_INVESTIGATOR","Jianxing He","Chief Physician and Professor of Thoracic Surgery","100651273","non-intubated-anesthesia-for-adult-heart-transplantation-100651273",false,"NCT07758894","Non-Intubated Anesthesia for Adult Heart Transplantation","Cardiopulmonary Protective Effects of Non-Intubated Spontaneous Ventilation Anesthesia in Heart Transplantation: A Multicenter, Prospective, Randomized Controlled Trial","NISVA-HTx","Inclusion Criteria:\n\nAge 18 years or older, regardless of sex. Listed for heart transplantation and scheduled to undergo isolated orthotopic heart transplantation.\n\nAble to breathe spontaneously without ongoing dependence on preoperative invasive mechanical ventilation.\n\nPerioperative anesthesia, surgical, intensive care unit, and follow-up data can be collected as required by the study protocol.\n\nConsidered eligible for either NISVA or conventional endotracheal anesthesia following multidisciplinary assessment by the heart transplant surgery, anesthesia, cardiopulmonary bypass, and intensive care teams.\n\nRelatively stable vital signs after appropriate treatment and able to complete perioperative assessments and postoperative follow-up.\n\nVoluntary participation and written informed consent provided by the participant or the participant's legally authorized representative.\n\nExclusion Criteria:\n\nPrevious solid-organ transplantation that may substantially affect the assessment of perioperative outcomes for the current transplantation.\n\nPlanned combined organ transplantation, including combined heart-kidney, heart-liver, or heart-lung transplantation.\n\nComplex anatomy associated with adult congenital heart disease that would substantially alter the surgical procedure or anesthetic management and is considered unsuitable for enrollment by the investigator.\n\nPreoperative endotracheal intubation or ongoing dependence on invasive mechanical ventilation.\n\nSevere pulmonary infection, severe respiratory failure, significant pulmonary edema, severe hypercapnia, or inability to tolerate a spontaneous ventilation anesthesia strategy, as determined by the study team.\n\nSevere pulmonary hypertension, severe right heart failure, or severely impaired baseline right ventricular function considered to present an unacceptably high risk for NISVA.\n\nSevere preoperative hemodynamic instability requiring high-dose vasoactive support, or use of mechanical circulatory support other than a durable left ventricular assist device or an intra-aortic balloon pump.\n\nKnown difficult airway, high risk of aspiration, full stomach, gastric retention, severe gastroesophageal reflux, or another contraindication to supraglottic airway use.\n\nEstimated glomerular filtration rate below 40 mL\u002Fmin\u002F1.73 m², need for dialysis or ultrafiltration, or rapidly progressive renal dysfunction.\n\nKnown liver disease-related coagulopathy, severe hepatic failure, or heparin-induced thrombocytopenia.\n\nA systemic disease that may substantially affect transplantation outcomes, including systemic lupus erythematosus, sarcoidosis, or amyloidosis.\n\nActive sepsis or a positive blood culture before surgery. ABO-incompatible transplantation. Ongoing pretransplant desensitization therapy, including peri-transplant plasma exchange or another treatment that may substantially affect inflammatory, immunologic, or outcome assessments.\n\nConcurrent participation in another interventional transplantation-related clinical trial that may affect the results of this study.\n\nPregnancy or breastfeeding. Inability to understand the study, inability to complete the informed consent process, or considered unsuitable for enrollment by the investigator.","ALL","18 Years",{"count":74,"type":75},300,"ESTIMATED","INTERVENTIONAL",[78],"NA","This prospective, multicenter, randomized controlled trial aims to evaluate whether non-intubated spontaneous ventilation anesthesia (NISVA) supported by a supraglottic airway can reduce cardiopulmonary complications and promote postoperative recovery in adults undergoing isolated orthotopic heart transplantation. Approximately 220 participants will be randomly assigned in a 1:1 ratio to either the NISVA group or the conventional endotracheal general anesthesia group. The study will primarily evaluate a cardiopulmonary composite endpoint within 30 days after transplantation. Postoperative invasive mechanical ventilation duration, pulmonary function recovery, intensive care unit length of stay, and other postoperative recovery outcomes will also be assessed. Participants will be followed during hospitalization and at 30 days, 3 months, and 1 year after transplantation to evaluate cardiopulmonary function, safety, postoperative recovery, rehospitalization, and survival.",[81],"Heart Transplant",[83,84],"Enhanced recovery after surgery","Heart transplant","2026-08-06",{"date":87,"type":88},"2026-08-11","ACTUAL",{"date":90,"type":75},"2026-07-30",{"date":92,"type":75},"2029-12-31",{"name":5,"class":6},1]