Nonintubated Supraglottic Airway Anesthesia With Early Restoration of Spontaneous Breathing Versus Conventional Endotracheal Fast-Track Anesthesia in Adults Undergoing Cardiac Surgery With Cardiopulmonary Bypass: A Multicenter Randomized Clinical 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
- Postoperative ICU Length of Stay
研究概览
简要总结
The goal of this prospective, multicenter, randomized clinical trial is to learn whether a nonintubated supraglottic airway anesthesia strategy with early restoration of spontaneous breathing can reduce postoperative pulmonary complications and improve early recovery in adults undergoing elective cardiac surgery with cardiopulmonary bypass.
The main questions it aims to answer are whether, compared with conventional endotracheal fast-track anesthesia, the nonintubated strategy can reduce pulmonary complications within 30 days after surgery, reduce the need for postoperative invasive mechanical ventilation and other respiratory support, and shorten the time spent in the intensive care unit.
Participants will be randomly assigned to undergo cardiac surgery using either a standardized nonintubated supraglottic airway anesthesia strategy with early restoration of spontaneous breathing or a conventional endotracheal fast-track anesthesia strategy. Both groups will receive standardized perioperative care, with objective criteria for airway removal and readiness for discharge from the intensive care unit. Endotracheal intubation or escalation of respiratory and circulatory support will be performed whenever clinically necessary.
Participants will be followed from screening through hospitalization, at 30 days after surgery, and for up to 1 year. Routine perioperative data and key postoperative outcomes, including pulmonary complications, respiratory support, intensive care unit stay, major organ complications, safety events, recovery, rehospitalization, and survival, will be collected.
详细描述
Purpose:
Adults undergoing cardiac surgery with cardiopulmonary bypass are at risk of postoperative pulmonary complications, prolonged respiratory support, and delayed recovery. This prospective, multicenter, randomized clinical trial (NIA-CPB) aims to evaluate the clinical effectiveness and perioperative safety of a nonintubated supraglottic airway anesthesia strategy with early restoration of spontaneous breathing. The strategy is designed to reduce exposure to endotracheal intubation and invasive mechanical ventilation while maintaining adequate oxygenation, ventilation, hemodynamic stability, and surgical conditions.
The study will compare this strategy with conventional endotracheal fast-track anesthesia in adults undergoing elective cardiac surgery with cardiopulmonary bypass. The primary objective is to determine whether the nonintubated strategy reduces pulmonary complications within 30 days after surgery. Additional objectives include evaluating postoperative invasive mechanical ventilation, other forms of respiratory support, intensive care unit stay, recovery, major organ complications, and safety.
Study Design and Methods:
NIA-CPB is a multicenter, parallel-group, randomized clinical trial that will enroll approximately 400 adults aged 18 years or older who are scheduled to undergo elective cardiac valve surgery or coronary artery bypass grafting with cardiopulmonary bypass. Participants will be randomly assigned in a 1:1 ratio to either the nonintubated anesthesia group or the conventional endotracheal anesthesia group.
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
- •Scheduled to undergo elective cardiac valve surgery with cardiopulmonary bypass
- •Considered eligible for either the non-intubated supraglottic airway anesthesia with early restoration of spontaneous breathing (NIA) strategy or the conventional anesthesia strategy, based on a joint preoperative assessment by the anesthesiology and cardiac surgery teams
- •Relatively stable vital signs and able to complete the required perioperative assessments and follow-up
- •Willing to participate in the study and able to provide written informed consent personally or through a legally authorized representative
排除标准
- •Emergency or urgent cardiac surgery
- •Severe pulmonary infection, severe respiratory failure, or another preoperative condition that clearly precludes use of the NIA strategy
- •Severe preoperative hemodynamic instability requiring high-dose vasoactive medications or mechanical circulatory support
- •Known difficult airway, high risk of aspiration, or another anesthetic contraindication to the NIA strategy
- •Severe hepatic, renal, or neurological disease that may substantially affect the assessment of perioperative outcomes
- •Pregnant or breastfeeding
- •Previous or concurrent participation in another interventional clinical trial that may affect the results of this study, if the participant remains within the relevant intervention or carryover period
- •Any other protocol-specified clinical condition that, in the opinion of the investigator, makes the participant unsuitable for enrollment
研究组 & 干预措施
Nonintubated Anesthesia Group
Participants assigned to this group will receive a standardized nonintubated supraglottic airway anesthesia strategy with early restoration of spontaneous breathing during cardiac surgery with cardiopulmonary bypass. Endotracheal intubation or escalation of respiratory and circulatory support will be performed when clinically necessary. Participants will receive standardized perioperative care and will be assessed using predefined physiologic criteria for airway removal and intensive care unit discharge readiness.
干预措施: Nonintubated Anesthesia Group (Procedure)
Conventional Anesthesia Group
Participants assigned to this group will receive standardized conventional general anesthesia with endotracheal intubation and lung-protective mechanical ventilation during cardiac surgery with cardiopulmonary bypass. Extubation or escalation of respiratory and circulatory support will be performed when clinically appropriate. Participants will receive standardized perioperative care and will be assessed using the same predefined physiologic criteria as the experimental group for airway removal and intensive care unit discharge readiness.
干预措施: Conventional Anesthesia Group (Procedure)
结局指标
主要结局
Postoperative ICU Length of Stay
时间窗: From the end of surgery until hospital discharge or in-hospital death, assessed up to 90 days after surgery.
Total duration of the initial ICU admission and any ICU readmission during the index hospitalization.
Cumulative Duration of Postoperative Respiratory Support
时间窗: From the end of surgery through postoperative Day 30.
Cumulative Duration of Postoperative Respiratory Support
Number of Participants With One or More Postoperative Pulmonary Complications Within 30 Days After Surgery
时间窗: From the end of surgery through postoperative Day 30.
Number of participants who experience at least one of the following postoperative pulmonary complications within 30 days after surgery: (1) cumulative postoperative invasive mechanical ventilation lasting more than 48 hours, calculated from the end of surgery and including both initial invasive ventilation and invasive ventilation after any subsequent reintubation; (2) unplanned reintubation after the first removal of the study airway because of respiratory failure, failure of airway protection, or another unplanned clinical indication; (3) tracheostomy performed for ongoing respiratory support or airway management; (4) moderate or severe acute respiratory distress syndrome (ARDS), according to the prespecified criteria in the endpoint definition manual; or (5) pneumonia, defined as a new or progressive pulmonary infiltrate together with the prespecified clinical, laboratory, and/or microbiological criteria in the endpoint definition manual.
次要结局
- Postoperative Multidimensional Recovery Assessed Using Standardized Clinical and Patient-Reported Measures(From baseline through postoperative Year 1)
- Perioperative Anesthetic Medication Requirements(From the induction of anesthesia to the end of surgery.)
- Number of Participants With Postoperative Cardiac Dysfunction(From the end of surgery through postoperative Day 30)
- Number of Participants With Postoperative Acute Kidney Injury(From the end of surgery through postoperative Day 7)
- Number of Participants With Major Postoperative Neurological Complications(From the end of surgery through postoperative Day 30)
- Number of Participants With Major Postoperative Infections(From the end of surgery through postoperative Day 30)
- Number of Participants With Postoperative Hepatic Injury(From the end of surgery through postoperative Day 30)
- Number of Participants With Major Postoperative Bleeding(From the end of surgery through postoperative Day 2)
- Number of Participants Requiring Unplanned Reoperation(From the end of surgery through postoperative Day 30)
研究者
Jianxing He
Chief Physician and Professor of Thoracic Surgery
The First Affiliated Hospital of Guangzhou Medical University