RecruitingNot ApplicableNCT07758894

Non-Intubated Anesthesia for Adult Heart Transplantation

Cardiopulmonary Protective Effects of Non-Intubated Spontaneous Ventilation Anesthesia in Heart Transplantation: A Multicenter, Prospective, Randomized Controlled Trial

Sponsor

The First Affiliated Hospital of Guangzhou Medical University

Enrollment

300 participants

Start Date

Jul 30, 2026

Study Type

INTERVENTIONAL

Conditions

Heart Transplant

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Conventional Anesthesia, a procedure called Non-Intubated Spontaneous Ventilation Anesthesia, and others for people with heart transplant. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURENon-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.

PROCEDUREConventional 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.

DRUGStandardized 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.