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.
Heart transplant recipients are at high risk of pulmonary complications and early graft dysfunction because of preexisting heart failure, cardiopulmonary bypass, ischemia-reperfusion injury, and perioperative hemodynamic changes. Conventional endotracheal intubation and mechanical ventilation provide reliable airway control but may contribute to airway injury, pulmonary complications, and delayed recovery. NISVA uses a supraglottic airway to maintain ventilation while preserving or restoring spontaneous breathing when clinically feasible, potentially reducing airway stimulation and mechanical ventilation exposure. Eligible adults undergoing isolated orthotopic heart transplantation will be randomly assigned to NISVA or conventional endotracheal general anesthesia. Both groups will receive standard perioperative heart transplantation care. Participant safety will take priority, and endotracheal intubation or additional respiratory or circulatory support will be provided whenever clinically necessary. In addition to the 30-day cardiopulmonary composite endpoint, the study will assess pulmonary recovery, early graft function, mechanical ventilation and circulatory support, major complications, safety events, recovery milestones, length of stay, rejection, quality of life, rehospitalization, and survival for up to 1 year. Key outcomes will be evaluated according to predefined criteria, with independent assessment of the primary endpoint.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
300
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.
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.
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.
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGIntensive 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.
Time frame: From postoperative admission to the intensive care unit until the first discharge from the intensive care unit, assessed during the index hospitalization and up to 30 days after surgery.
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.
Time frame: From the end of surgery through 30 days after transplantation.
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.
Time frame: Within 30 days after heart transplantation
Incidence of Other Postoperative Complications
Proportion of participants experiencing other postoperative complications, including renal, hepatic, neurological, infectious, bleeding, and other clinically significant adverse events.
Time frame: From the end of heart transplantation through postoperative Day 30; complications will be recorded throughout the index hospitalization and assessed at postoperative Day 30.
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.
Time frame: At discharge from the post-transplant hospitalization, and at 30 days, 3 months, and 1 year after heart transplantation
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 frame: From induction of anesthesia through completion of the surgical procedure.
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.
Time frame: From completion of surgery until the first oral intake, assessed through discharge from the index postoperative hospitalization.
6-Minute Walk Distance
6-minute walk distance will be assessed using the standardized 6-minute walk test and reported in meters. The minimum possible value is 0 meters; there is no prespecified maximum value. A greater distance indicates better functional capacity.
Time frame: At discharge from the post-transplant hospitalization, and at 30 days, 3 months, and 1 year after heart transplantation
Postoperative Hospital Length of Stay
Postoperative hospital length of stay will be measured from the date of surgery to the date of discharge from the index postoperative hospitalization and reported in days.
Time frame: From the date of surgery through the date of discharge from the index postoperative hospitalization.
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