Cardiopulmonary Protective Effects of Non-Intubated Spontaneous Ventilation Anesthesia in Heart Transplantation: A Multicenter, Prospective, Randomized Controlled Trial
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.
• Age 18 years or older, regardless of sex. Listed for heart transplantation and scheduled to undergo isolated orthotopic heart transplantation.
• Able to breathe spontaneously without ongoing dependence on preoperative invasive mechanical ventilation.
• Perioperative anesthesia, surgical, intensive care unit, and follow-up data can be collected as required by the study protocol.
• Considered eligible for either NISVA or conventional endotracheal anesthesia following multidisciplinary assessment by the heart transplant surgery, anesthesia, cardiopulmonary bypass, and intensive care teams.
• Relatively stable vital signs after appropriate treatment and able to complete perioperative assessments and postoperative follow-up.
• Voluntary participation and written informed consent provided by the participant or the participant's legally authorized representative.