Heart TransplantNISVA-HTxNCT07758894
Non-Intubated Anesthesia for Adult Heart Transplantation
A study testing Non-Intubated Spontaneous Ventilation Anesthesia, Conventional Anesthesia and Standardized Perioperative Anesthetic and Analgesic Medication Regimen in people with Heart Transplant, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Transplant
- What is being tested?
- Non-Intubated Spontaneous Ventilation Anesthesia, Conventional Anesthesia and Standardized Perioperative Anesthetic and Analgesic Medication Regimen
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 450051
Haoxiang Yuan, +8615692028041, 2024390294@gzhmu.edu.cn
About this study
Official title: Cardiopulmonary Protective Effects of Non-Intubated Spontaneous Ventilation Anesthesia in Heart Transplantation: A Multicenter, Prospective, Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Heart Transplant
- Being tested
- Non-Intubated Spontaneous Ventilation Anesthesia, Conventional Anesthesia, Standardized Perioperative Anesthetic and Analgesic Medication Regimen
- Keywords
- Enhanced recovery after surgery, Heart transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Intubated Spontaneous Ventilation AnesthesiaProcedure or surgery
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.
Conventional AnesthesiaProcedure or surgery
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.
Standardized Perioperative Anesthetic and Analgesic Medication RegimenDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Conventional Anesthesia; Drug: Standardized Perioperative Anesthetic and Analgesic Medication Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Within 30 days after heart transplantation
Secondary outcomes (6)
Incidence of Other Postoperative Complications
Proportion of participants experiencing other postoperative complications, including renal, hepatic, neurological, infectious, bleeding, and other clinically significant adverse events.
Measured: 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
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.
Measured: 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
Total doses of anesthetic, sedative, neuromuscular blocking, and opioid medications administered during the perioperative period will be recorded and compared between groups.
Measured: From induction of anesthesia through completion of the surgical procedure.
Time to First Oral Intake
Time from completion of surgery to the first documented oral intake of liquids or solid food will be recorded and reported in hours.
Measured: From completion of surgery until the first oral intake, assessed through discharge from the index postoperative hospitalization.
6-Minute Walk Distance
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.
Measured: At discharge from the post-transplant hospitalization, and at 30 days, 3 months, and 1 year after heart transplantation
Postoperative Hospital Length of Stay
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.
Measured: From the date of surgery through the date of discharge from the index postoperative hospitalization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start30 Jul 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart TransplantStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianxing He, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07758894
- Sponsor's protocol ID
- GMUFAH-NISVA-HTx
- Acronym
- NISVA-HTx
- Status last verified
- Aug 2026
- First submitted
- 31 Jul 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the primary and secondary outcome results, including baseline characteristics, intervention assignment, and outcome measures, will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiopulmonary Protective Effects of Non-Intubated Spontaneous Ventilation Anesthesia in Heart Transplantation: A Multicenter, Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07758894
- Acronym / sponsor ID
- NISVA-HTx / GMUFAH-NISVA-HTx
- Conditions
- Heart Transplant
- Keywords
- Enhanced recovery after surgery, Heart transplant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 30 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Intubated Spontaneous Ventilation Anesthesia Group | Experimental | Procedure: Non-Intubated Spontaneous Ventilation Anesthesia, Drug: Standardized Perioperative Anesthetic and Analgesic Medication RegimenParticipants 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. |
| Conventional Anesthesia Group | Active comparator | Procedure: Conventional Anesthesia, Drug: Standardized Perioperative Anesthetic and Analgesic Medication RegimenParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Intubated Spontaneous Ventilation AnesthesiaA 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. | Procedure or surgery | Non-Intubated Spontaneous Ventilation Anesthesia Group |
| Conventional AnesthesiaA 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. | Procedure or surgery | Conventional Anesthesia Group |
| Standardized Perioperative Anesthetic and Analgesic Medication RegimenAnesthesia 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. | Drug | Conventional Anesthesia Group, Non-Intubated Spontaneous Ventilation Anesthesia Group |
Primary outcome
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.
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.
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.
6 secondary outcomes
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.
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
Perioperative Anesthetic and Analgesic Medication Use
Time frame: 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.
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
Postoperative Hospital Length of Stay
Time frame: From the date of surgery through the date of discharge from the index postoperative hospitalization.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the primary and secondary outcome results, including baseline characteristics, intervention assignment, and outcome measures, will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Intubated Spontaneous Ventilation Anesthesia, Conventional Anesthesia and Standardized Perioperative Anesthetic and Analgesic Medication Regimen in people with Heart Transplant, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haoxiang Yuan (+8615692028041, 2024390294@gzhmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.