Non-Intubated Anesthesia for Adult Heart Transplantation (NISVA-HTx)
Cardiopulmonary Protective Effects of Non-Intubated Spontaneous Ventilation Anesthesia in Heart Transplantation: A Multicenter, Prospective, Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Haoxiang Yuan
- Phone Number: +8615692028041
- Email: 2024390294@gzhmu.edu.cn
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 450051
- Recruiting
- The First Affiliated Hospital of Guangzhou Medical University
-
Contact:
- Haoxiang Yuan
- Phone Number: +8615692028041
- Email: 2024390294@gzhmu.edu.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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, 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
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.
|
|
Active Comparator: 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.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intensive Care Unit Length of Stay
Time Frame: 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.
|
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
Time Frame: 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.
|
From the end of surgery through 30 days after transplantation.
|
|
Incidence of the Cardiopulmonary Composite Endpoint
Time Frame: 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.
|
Within 30 days after heart transplantation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of Other Postoperative Complications
Time Frame: From the end of heart transplantation through postoperative Day 30; complications will be recorded throughout the index hospitalization and assessed at postoperative Day 30.
|
Proportion of participants experiencing other postoperative complications, including renal, hepatic, neurological, infectious, bleeding, and other clinically significant adverse events.
|
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
Time Frame: At discharge from the post-transplant hospitalization, and at 30 days, 3 months, and 1 year after heart transplantation
|
New York Heart Association functional class will be assessed clinically and reported as Class I, II, III, or IV.
Class I indicates no limitation of physical activity, whereas Class IV indicates symptoms at rest and the most severe limitation.
Higher class indicates worse functional status.
|
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
Time Frame: From induction of anesthesia through completion of the surgical procedure.
|
Total doses of anesthetic, sedative, neuromuscular blocking, and opioid medications administered during the perioperative period will be recorded and compared between groups.
|
From induction of anesthesia through completion of the surgical procedure.
|
|
Time to First Oral Intake
Time Frame: From completion of surgery until the first oral intake, assessed through discharge from the index postoperative hospitalization.
|
Time from completion of surgery to the first documented oral intake of liquids or solid food will be recorded and reported in hours.
|
From completion of surgery until the first oral intake, assessed through discharge from the index postoperative hospitalization.
|
|
6-Minute Walk Distance
Time Frame: At discharge from the post-transplant hospitalization, and at 30 days, 3 months, and 1 year after heart transplantation
|
6-minute walk distance will be assessed using the standardized 6-minute walk test and reported in meters.
The minimum possible value is 0 meters; there is no prespecified maximum value.
A greater distance indicates better functional capacity.
|
At discharge from the post-transplant hospitalization, and at 30 days, 3 months, and 1 year after heart transplantation
|
|
Postoperative Hospital Length of Stay
Time Frame: From the date of surgery through the date of discharge from the index postoperative hospitalization.
|
Postoperative hospital length of stay will be measured from the date of surgery to the date of discharge from the index postoperative hospitalization and reported in days.
|
From the date of surgery through the date of discharge from the index postoperative hospitalization.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- GMUFAH-NISVA-HTx
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.