Recruiting
Not applicable
Non-Intubated Anesthesia for Adult Heart Transplantation
Condition(s) studied
Heart Transplant
Investigational drug(s) / intervention(s)
Non-Intubated Spontaneous Ventilation AnesthesiaConventional AnesthesiaStandardized Perioperative Anesthetic and Analgesic Medication Regimen
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.
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.
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.
Study summary
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.
Eligibility
Inclusion Criteria:
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.
Exclusion Criteria:
Previous solid-organ transplantation that may substantially affect the assessment of perioperative outcomes for the current transplantation.
Planned combined organ transplantation, including combined heart-kidney, heart-liver, or heart-lung transplantation.
Complex 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.
Preoperative endotracheal intubation or ongoing dependence on invasive mechanical ventilation.
Severe 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.
Severe pulmonary hypertension, severe right heart failure, or severely impaired baseline right ventricular function considered to present an unacceptably high risk for NISVA.
Severe 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.
Known difficult airway, high risk of aspiration, full stomach, gastric retention, severe gastroesophageal reflux, or another contraindication to supraglottic airway use.
Estimated glomerular filtration rate below 40 mL/min/1.73 m², need for dialysis or ultrafiltration, or rapidly progressive renal dysfunction.
Known liver disease-related coagulopathy, severe hepatic failure, or heparin-induced thrombocytopenia.
A systemic disease that may substantially affect transplantation outcomes, including systemic lupus erythematosus, sarcoidosis, or amyloidosis.
Active 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.
Concurrent participation in another interventional transplantation-related clinical trial that may affect the results of this study.
Pregnancy or breastfeeding. Inability to understand the study, inability to complete the informed consent process, or considered unsuitable for enrollment by the investigator.
Primary outcome measure(s)
- Intensive Care Unit Length of Stay — 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 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 — From the end of surgery through 30 days after transplantation.
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 — Within 30 days after heart transplantation
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.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| The First Affiliated Hospital of Guangzhou Medical University |
Guangzhou |
Guangdong |
Recruiting |
More The First Affiliated Hospital of Guangzhou Medical University trials in China