Non-Intubated Anesthesia for Adult Heart Transplantation

NCT07758894 | Recruiting

• 1 other identifier: GMUFAH-NISVA-HTx
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Transplant

Keywords

Enhanced recovery after surgery; Heart transplant

Outcome Measures

Primary Outcomes (3)

• Intensive Care Unit Length of Stay

  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.

  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 Postoperative Invasive Mechanical Ventilation

  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.

  From the end of surgery through 30 days after transplantation.

• Incidence of the Cardiopulmonary Composite Endpoint

  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.

  Within 30 days after heart transplantation

Secondary Outcomes (6)

• 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

Study Arms (2)

Non-Intubated Spontaneous Ventilation Anesthesia Group

EXPERIMENTAL

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.

Procedure: Non-Intubated Spontaneous Ventilation Anesthesia; Drug: Standardized Perioperative Anesthetic and Analgesic Medication Regimen

Conventional Anesthesia Group

ACTIVE COMPARATOR

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.

Procedure: Conventional Anesthesia; Drug: Standardized Perioperative Anesthetic and Analgesic Medication Regimen

Interventions

Non-Intubated Spontaneous Ventilation Anesthesia PROCEDURE

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.

Non-Intubated Spontaneous Ventilation Anesthesia Group

Conventional Anesthesia PROCEDURE

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.

Conventional Anesthesia Group

Standardized Perioperative Anesthetic and Analgesic Medication Regimen DRUG

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.

Conventional Anesthesia Group; Non-Intubated Spontaneous Ventilation Anesthesia Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 450051, China

RECRUITING

Central Study Contacts

Haoxiang Yuan

CONTACT

+8615692028041; 2024390294@gzhmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician and Professor of Thoracic Surgery

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 11, 2026
• Study Start: July 30, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: IPD and supporting information will be available after publication of the primary study results, beginning approximately 6 months after publication, and will remain available for up to 5 years.
• Access Criteria: Access to de-identified IPD and supporting information will be granted to qualified researchers upon reasonable request. Requests must include a brief research proposal and analysis plan and be approved by the study investigators. Data will be shared for academic research purposes only, without any attempt to re-identify participants. Data will be provided through secure data transfer methods.

Locations

CN (1)