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.
None
None
Parallel
Non-Intubated Spontaneous Ventilation Anesthesia
Procedure/SurgeryA 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.
Conventional Anesthesia
Procedure/SurgeryA 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.
Standardized Perioperative Anesthetic and Analgesic Medication Regimen
DrugAnesthesia 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.
Intensive Care Unit Length of Stay
Duration of intensive care unit stay after heart transplantation, measured in days from postoperative admission to the intensive care unit until the first discharge from the intensive care unit during the index hospitalization.
Duration of Postoperative Invasive Mechanical Ventilation
Total duration of postoperative invasive mechanical ventilation after heart transplantation. Participants who do not receive postoperative invasive mechanical ventilation will be recorded as having a duration of zero.
Incidence of the Cardiopulmonary Composite Endpoint
Proportion of participants experiencing at least one major cardiopulmonary complication, including death, primary graft dysfunction, graft failure requiring mechanical circulatory support or repeat transplantation, or severe postoperative respiratory dysfunction.
Incidence of Other Postoperative Complications
Proportion of participants experiencing other postoperative complications, including renal, hepatic, neurological, infectious, bleeding, and other clinically significant adverse events.
New York Heart Association Functional Class
New York Heart Association functional class will be assessed clinically and reported as Class I, II, III, or IV. Class I indicates no limitation of physical activity, whereas Class IV indicates symptoms at rest and the most severe limitation. Higher class indicates worse functional status.
Perioperative Anesthetic and Analgesic Medication Use
Total doses of anesthetic, sedative, neuromuscular blocking, and opioid medications administered during the perioperative period will be recorded and compared between groups.
Time to First Oral Intake
Time from completion of surgery to the first documented oral intake of liquids or solid food will be recorded and reported in hours.
Click on the lead sponsor to view all of their trials.
