Cardiopulmonary Protective Effects of Non-Intubated Spontaneous Ventilation Anesthesia in Heart Transplantation: A Multicenter, Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Intensive Care Unit Length of Stay
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Non-Intubated Spontaneous Ventilation Anesthesia Group
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.
干预措施: Non-Intubated Spontaneous Ventilation Anesthesia (Procedure)
Non-Intubated Spontaneous Ventilation Anesthesia Group
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.
干预措施: Standardized Perioperative Anesthetic and Analgesic Medication Regimen (Drug)
Conventional Anesthesia Group
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.
干预措施: Conventional Anesthesia (Procedure)
Conventional Anesthesia Group
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.
干预措施: Standardized Perioperative Anesthetic and Analgesic Medication Regimen (Drug)
结局指标
主要结局
Intensive Care Unit Length of Stay
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Incidence of Other Postoperative Complications(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(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(From induction of anesthesia through completion of the surgical procedure.)
- Time to First Oral Intake(From completion of surgery until the first oral intake, assessed through discharge from the index postoperative hospitalization.)
- 6-Minute Walk Distance(At discharge from the post-transplant hospitalization, and at 30 days, 3 months, and 1 year after heart transplantation)
- Postoperative Hospital Length of Stay(From the date of surgery through the date of discharge from the index postoperative hospitalization.)
研究者
Jianxing He
Chief Physician and Professor of Thoracic Surgery
The First Affiliated Hospital of Guangzhou Medical University