Non-Intubated Anesthesia for Adult Heart Transplantation
China300 participantsStarted 2026-07-30
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, s…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Intensive Care Unit Length of Stay
Timeframe: 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.
2
Duration of Postoperative Invasive Mechanical Ventilation
Timeframe: From the end of surgery through 30 days after transplantation.
3
Incidence of the Cardiopulmonary Composite Endpoint
Timeframe: Within 30 days after heart transplantation
Trial details
NCT IDNCT07758894
SponsorThe First Affiliated Hospital of Guangzhou Medical University