Valve Disease, HeartNIA-HeartNCT07744009
Nonintubated Anesthesia for Adult Cardiac Surgery With Cardiopulmonary Bypass
A study testing Nonintubated Anesthesia Group and Conventional Anesthesia Group in people with Valve Disease, Heart and CABG, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
The goal of this prospective, multicenter, randomized clinical trial is to learn whether a nonintubated supraglottic airway anesthesia strategy with early restoration of spontaneous breathing can reduce postoperative pulmonary complications and improve early recovery in adults undergoing elective cardiac surgery with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Valve Disease, Heart, CABG
- What is being tested?
- Nonintubated Anesthesia Group and Conventional Anesthesia Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 21 Jul 2026to 31 Dec 2028
- 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
- Scheduled to undergo elective cardiac valve surgery with cardiopulmonary bypass
- Considered eligible for either the non-intubated supraglottic airway anesthesia with early restoration of spontaneous breathing (NIA) strategy or the conventional anesthesia strategy, based on a joint preoperative assessment by the anesthesiology and cardiac surgery teams
- Relatively stable vital signs and able to complete the required perioperative assessments and follow-up
- Willing to participate in the study and able to provide written informed consent personally or through a legally authorized representative
Who cannot join
- Emergency or urgent cardiac surgery
- Severe pulmonary infection, severe respiratory failure, or another preoperative condition that clearly precludes use of the NIA strategy
- Severe preoperative hemodynamic instability requiring high-dose vasoactive medications or mechanical circulatory support
- Known difficult airway, high risk of aspiration, or another anesthetic contraindication to the NIA strategy
- Severe hepatic, renal, or neurological disease that may substantially affect the assessment of perioperative outcomes
- Pregnant or breastfeeding
- Previous or concurrent participation in another interventional clinical trial that may affect the results of this study, if the participant remains within the relevant intervention or carryover period
- Any other protocol-specified clinical condition that, in the opinion of the investigator, makes the participant unsuitable for enrollment
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 Yuan, +8615692028041, 2024390294@gzhmu.edu.cn
About this study
Official title: Nonintubated Supraglottic Airway Anesthesia With Early Restoration of Spontaneous Breathing Versus Conventional Endotracheal Fast-Track Anesthesia in Adults Undergoing Cardiac Surgery With Cardiopulmonary Bypass: A Multicenter Randomized Clinical Trial
The goal of this prospective, multicenter, randomized clinical trial is to learn whether a nonintubated supraglottic airway anesthesia strategy with early restoration of spontaneous breathing can reduce postoperative pulmonary complications and improve early recovery in adults undergoing elective cardiac surgery with cardiopulmonary bypass.
The main questions it aims to answer are whether, compared with conventional endotracheal fast-track anesthesia, the nonintubated strategy can reduce pulmonary complications within 30 days after surgery, reduce the need for postoperative invasive mechanical ventilation and other respiratory support, and shorten the time spent in the intensive care unit.
Read more
Participants will be randomly assigned to undergo cardiac surgery using either a standardized nonintubated supraglottic airway anesthesia strategy with early restoration of spontaneous breathing or a conventional endotracheal fast-track anesthesia strategy. Both groups will receive standardized perioperative care, with objective criteria for airway removal and readiness for discharge from the intensive care unit. Endotracheal intubation or escalation of respiratory and circulatory support will be performed whenever clinically necessary.
Participants will be followed from screening through hospitalization, at 30 days after surgery, and for up to 1 year. Routine perioperative data and key postoperative outcomes, including pulmonary complications, respiratory support, intensive care unit stay, major organ complications, safety events, recovery, rehospitalization, and survival, will be collected.
Read the detailed description
Purpose:
Adults undergoing cardiac surgery with cardiopulmonary bypass are at risk of postoperative pulmonary complications, prolonged respiratory support, and delayed recovery. This prospective, multicenter, randomized clinical trial (NIA-CPB) aims to evaluate the clinical effectiveness and perioperative safety of a nonintubated supraglottic airway anesthesia strategy with early restoration of spontaneous breathing. The strategy is designed to reduce exposure to endotracheal intubation and invasive mechanical ventilation while maintaining adequate oxygenation, ventilation, hemodynamic stability, and surgical conditions.
The study will compare this strategy with conventional endotracheal fast-track anesthesia in adults undergoing elective cardiac surgery with cardiopulmonary bypass. The primary objective is to determine whether the nonintubated strategy reduces pulmonary complications within 30 days after surgery. Additional objectives include evaluating postoperative invasive mechanical ventilation, other forms of respiratory support, intensive care unit stay, recovery, major organ complications, and safety.
Study Design and Methods:
NIA-CPB is a multicenter, parallel-group, randomized clinical trial that will enroll approximately 400 adults aged 18 years or older who are scheduled to undergo elective cardiac valve surgery or coronary artery bypass grafting with cardiopulmonary bypass. Participants will be randomly assigned in a 1:1 ratio to either the nonintubated anesthesia group or the conventional endotracheal anesthesia group.
Participants assigned to the intervention group will receive a standardized perioperative anesthesia strategy using a supraglottic airway without routine endotracheal intubation and with early restoration of spontaneous breathing when clinically feasible. Participants assigned to the control group will receive conventional endotracheal fast-track anesthesia. Both groups will receive standardized perioperative care and will be assessed using the same objective physiologic criteria for airway removal and readiness for discharge from the intensive care unit. Participants in the control group may undergo extubation in the operating room when the predefined criteria are met.
Patient safety will take priority over adherence to the assigned airway strategy. Predefined clinical criteria will guide conversion to endotracheal intubation or escalation of respiratory or circulatory support when necessary, including inadequate oxygenation or ventilation, hemodynamic instability, airway device failure, suspected aspiration, major bleeding, or surgical requirements.
The primary endpoint is a composite of pulmonary complications occurring within 30 days after surgery, including prolonged postoperative invasive mechanical ventilation, unplanned re-intubation, tracheostomy, moderate or severe acute respiratory distress syndrome, and pneumonia. The individual components of the composite endpoint will also be reported. Additional clinical and safety outcomes will be collected during hospitalization and follow-up.
Participants will be followed from screening through hospitalization, at 30 days after surgery, and for up to 1 year. An independent committee blinded to treatment assignment will assess key pulmonary outcomes using predefined criteria.
Anticipated Results:
The investigators hypothesize that, compared with conventional endotracheal fast-track anesthesia, the nonintubated supraglottic airway strategy with early restoration of spontaneous breathing will reduce postoperative pulmonary complications, decrease the need for invasive mechanical ventilation and other advanced respiratory support, and support earlier recovery from intensive care.
The study is expected to provide multicenter randomized evidence regarding the effectiveness, feasibility, and safety of this perioperative anesthesia strategy in adults undergoing cardiac surgery with cardiopulmonary bypass. The findings may help inform future perioperative airway and respiratory management practices in adult cardiac surgery.
- Conditions
- Valve Disease, Heart, CABG
- Being tested
- Nonintubated Anesthesia Group, Conventional Anesthesia Group
- Keywords
- Enhanced recovery after surgert, cardiac surgery
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nonintubated Anesthesia GroupProcedure 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 Anesthesia GroupProcedure 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.
| Study group | Role | What they receive |
|---|---|---|
| Nonintubated Anesthesia Group | Experimental | Participants assigned to this group will receive a standardized nonintubated supraglottic airway anesthesia strategy with early restoration of spontaneous breathing during cardiac surgery with cardiopulmonary bypass. Endotracheal intubation or escalation of respiratory and circulatory support will be performed when clinically necessary. Participants will receive standardized perioperative care and will be assessed using predefined physiologic criteria for airway removal and intensive care unit discharge readiness. Receives: Procedure: Nonintubated Anesthesia Group |
| Conventional Anesthesia Group | Active comparator | Participants assigned to this group will receive standardized conventional general anesthesia with endotracheal intubation and lung-protective mechanical ventilation during cardiac surgery with cardiopulmonary bypass. Extubation or escalation of respiratory and circulatory support will be performed when clinically appropriate. Participants will receive standardized perioperative care and will be assessed using the same predefined physiologic criteria as the experimental group for airway removal and intensive care unit discharge readiness. Receives: Procedure: Conventional Anesthesia Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative ICU Length of Stay
Total duration of the initial ICU admission and any ICU readmission during the index hospitalization.
Measured: From the end of surgery until hospital discharge or in-hospital death, assessed up to 90 days after surgery.
Cumulative Duration of Postoperative Respiratory Support
Cumulative Duration of Postoperative Respiratory Support
Measured: From the end of surgery through postoperative Day 30.
Number of Participants With One or More Postoperative Pulmonary Complications Within 30 Days After Surgery
Number of participants who experience at least one of the following postoperative pulmonary complications within 30 days after surgery: (1) cumulative postoperative invasive mechanical ventilation lasting more than 48 hours, calculated from the end of surgery and including both initial invasive ventilation and invasive ventilation after any subsequent reintubation; (2) unplanned reintubation after the first removal of the study airway because of respiratory failure, failure of airway protection, or another unplanned clinical indication; (3) tracheostomy performed for ongoing respiratory support or airway management; (4) moderate or severe acute respiratory distress syndrome (ARDS), according to the prespecified criteria in the endpoint definition manual; or (5) pneumonia, defined as a new or progressive pulmonary infiltrate together with the prespecified clinical, laboratory, and/or microbiological criteria in the endpoint definition manual.
Measured: From the end of surgery through postoperative Day 30.
Secondary outcomes (9)
Postoperative Multidimensional Recovery Assessed Using Standardized Clinical and Patient-Reported Measures
Postoperative multidimensional recovery will be assessed using standardized clinical and patient-reported measures covering heart disease-related functional status and quality of life, cognitive status, pain, depressive symptoms, anxiety symptoms, and emotional well-being. Assessments will include the Minnesota Living With Heart Failure Questionnaire (MLHFQ), the 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12), the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), the Numerical Rating Scale (NRS) for pain, the 9-item Patient Health Questionnaire (PHQ-9), the 7-item Generalized Anxiety Disorder scale (GAD-7), and the Positive and Negative Affect Schedule (PANAS). Each instrument will be scored and analyzed separately according to its validated scoring method; scores from different instruments will not be combined into a single composite score. Changes from baseline and scores at prespecified postoperative time points will be reported, as applicable.
Measured: From baseline through postoperative Year 1
Perioperative Anesthetic Medication Requirements
Cumulative doses of prespecified anesthetic medications administered during the perioperative period, including intravenous and inhaled anesthetics, sedatives, opioid analgesics, and neuromuscular blocking agents. Each medication or medication class will be recorded and analyzed separately using prespecified units.
Measured: From the induction of anesthesia to the end of surgery.
Number of Participants With Postoperative Cardiac Dysfunction
participants who develop new or worsening postoperative low cardiac output syndrome
Measured: From the end of surgery through postoperative Day 30
Number of Participants With Postoperative Acute Kidney Injury
Acute kidney injury diagnosed based on the KDIGO criteria after surgery
Measured: From the end of surgery through postoperative Day 7
Number of Participants With Major Postoperative Neurological Complications
Number of participants who experience at least one major postoperative neurological complication, including stroke, transient ischemic attack, persistent coma, or an unprovoked seizure.
Measured: From the end of surgery through postoperative Day 30
Number of Participants With Major Postoperative Infections
surgical-site infection, pneumonia, bloodstream infection, urinary tract infection, or mediastinitis.
Measured: From the end of surgery through postoperative Day 30
Number of Participants With Postoperative Hepatic Injury
Number of participants who develop postoperative hepatic injury, defined as alanine aminotransferase or aspartate aminotransferase at least 5 times the upper limit of normal, or at least 3 times the upper limit of normal together with total bilirubin at least 2 times the upper limit of normal. Pre-existing abnormalities and clearly identified alternative causes will be excluded.
Measured: From the end of surgery through postoperative Day 30
Number of Participants With Major Postoperative Bleeding
Number of participants who experience major postoperative bleeding, defined as intracranial bleeding within 48 hours after surgery, reoperation for bleeding, transfusion of at least 5 units of whole blood or packed red blood cells within 48 hours, or chest-tube output of at least 2000 mL within 24 hours after surgery.
Measured: From the end of surgery through postoperative Day 2
Number of Participants Requiring Unplanned Reoperation
Number of participants who undergo at least one unplanned surgical reoperation because of a postoperative complication. Planned staged procedures and minor bedside procedures are excluded. Participants undergoing multiple reoperations will be counted once.
Measured: From the end of surgery through postoperative Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start21 Jul 2026
- Primary completion30 Jul 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valve Disease, HeartStudies 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
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel perioperative anesthesia strategy 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
- NCT07744009
- Sponsor's protocol ID
- GMUFAH-NIACardiac-2026
- Acronym
- NIA-Heart
- Status last verified
- Aug 2026
- First submitted
- 28 Jul 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share de-identified individual participant data (IPD) underlying the results reported in the primary publication of this clinical trial. Shared IPD may include baseline demographic and clinical characteristics, surgical procedure, randomized treatment assignment, anesthesia and airway management, ventilation and respiratory support data, perioperative interventions, protocol adherence and strategy conversion, postoperative pulmonary complications, ICU and hospital outcomes, adverse events, mortality, and other prespecified outcomes during follow-up. The study protocol, statistical analysis plan, data dictionary, and relevant analytic code will also be made available. All direct identifiers will be removed, and dates or potentially identifying variables will be shifted, aggregated, or otherwise processed as necessary to protect participant privacy.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nonintubated Supraglottic Airway Anesthesia With Early Restoration of Spontaneous Breathing Versus Conventional Endotracheal Fast-Track Anesthesia in Adults Undergoing Cardiac Surgery With Cardiopulmonary Bypass: A Multicenter Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07744009
- Acronym / sponsor ID
- NIA-Heart / GMUFAH-NIACardiac-2026
- Conditions
- Valve Disease, Heart, CABG
- Keywords
- Enhanced recovery after surgert, cardiac surgery
- 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
- 21 Jul 2026 (actual)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 4 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.
The goal of this prospective, multicenter, randomized clinical trial is to learn whether a nonintubated supraglottic airway anesthesia strategy with early restoration of spontaneous breathing can reduce postoperative pulmonary complications and improve early recovery in adults undergoing elective cardiac surgery with cardiopulmonary bypass.
The main questions it aims to answer are whether, compared with conventional endotracheal fast-track anesthesia, the nonintubated strategy can reduce pulmonary complications within 30 days after surgery, reduce the need for postoperative invasive mechanical ventilation and other respiratory support, and shorten the time spent in the intensive care unit.
Participants will be randomly assigned to undergo cardiac surgery using either a standardized nonintubated supraglottic airway anesthesia strategy with early restoration of spontaneous breathing or a conventional endotracheal fast-track anesthesia strategy. Both groups will receive standardized perioperative care, with objective criteria for airway removal and readiness for discharge from the intensive care unit. Endotracheal intubation or escalation of respiratory and circulatory support will be performed whenever clinically necessary.
Participants will be followed from screening through hospitalization, at 30 days after surgery, and for up to 1 year. Routine perioperative data and key postoperative outcomes, including pulmonary complications, respiratory support, intensive care unit stay, major organ complications, safety events, recovery, rehospitalization, and survival, will be collected.
Detailed description
Purpose:
Adults undergoing cardiac surgery with cardiopulmonary bypass are at risk of postoperative pulmonary complications, prolonged respiratory support, and delayed recovery. This prospective, multicenter, randomized clinical trial (NIA-CPB) aims to evaluate the clinical effectiveness and perioperative safety of a nonintubated supraglottic airway anesthesia strategy with early restoration of spontaneous breathing. The strategy is designed to reduce exposure to endotracheal intubation and invasive mechanical ventilation while maintaining adequate oxygenation, ventilation, hemodynamic stability, and surgical conditions.
The study will compare this strategy with conventional endotracheal fast-track anesthesia in adults undergoing elective cardiac surgery with cardiopulmonary bypass. The primary objective is to determine whether the nonintubated strategy reduces pulmonary complications within 30 days after surgery. Additional objectives include evaluating postoperative invasive mechanical ventilation, other forms of respiratory support, intensive care unit stay, recovery, major organ complications, and safety.
Study Design and Methods:
NIA-CPB is a multicenter, parallel-group, randomized clinical trial that will enroll approximately 400 adults aged 18 years or older who are scheduled to undergo elective cardiac valve surgery or coronary artery bypass grafting with cardiopulmonary bypass. Participants will be randomly assigned in a 1:1 ratio to either the nonintubated anesthesia group or the conventional endotracheal anesthesia group.
Participants assigned to the intervention group will receive a standardized perioperative anesthesia strategy using a supraglottic airway without routine endotracheal intubation and with early restoration of spontaneous breathing when clinically feasible. Participants assigned to the control group will receive conventional endotracheal fast-track anesthesia. Both groups will receive standardized perioperative care and will be assessed using the same objective physiologic criteria for airway removal and readiness for discharge from the intensive care unit. Participants in the control group may undergo extubation in the operating room when the predefined criteria are met.
Patient safety will take priority over adherence to the assigned airway strategy. Predefined clinical criteria will guide conversion to endotracheal intubation or escalation of respiratory or circulatory support when necessary, including inadequate oxygenation or ventilation, hemodynamic instability, airway device failure, suspected aspiration, major bleeding, or surgical requirements.
The primary endpoint is a composite of pulmonary complications occurring within 30 days after surgery, including prolonged postoperative invasive mechanical ventilation, unplanned re-intubation, tracheostomy, moderate or severe acute respiratory distress syndrome, and pneumonia. The individual components of the composite endpoint will also be reported. Additional clinical and safety outcomes will be collected during hospitalization and follow-up.
Participants will be followed from screening through hospitalization, at 30 days after surgery, and for up to 1 year. An independent committee blinded to treatment assignment will assess key pulmonary outcomes using predefined criteria.
Anticipated Results:
The investigators hypothesize that, compared with conventional endotracheal fast-track anesthesia, the nonintubated supraglottic airway strategy with early restoration of spontaneous breathing will reduce postoperative pulmonary complications, decrease the need for invasive mechanical ventilation and other advanced respiratory support, and support earlier recovery from intensive care.
The study is expected to provide multicenter randomized evidence regarding the effectiveness, feasibility, and safety of this perioperative anesthesia strategy in adults undergoing cardiac surgery with cardiopulmonary bypass. The findings may help inform future perioperative airway and respiratory management practices in adult cardiac surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel perioperative anesthesia strategy groups.
| Arm | Type | Receives |
|---|---|---|
| Nonintubated Anesthesia Group | Experimental | Procedure: Nonintubated Anesthesia GroupParticipants assigned to this group will receive a standardized nonintubated supraglottic airway anesthesia strategy with early restoration of spontaneous breathing during cardiac surgery with cardiopulmonary bypass. Endotracheal intubation or escalation of respiratory and circulatory support will be performed when clinically necessary. Participants will receive standardized perioperative care and will be assessed using predefined physiologic criteria for airway removal and intensive care unit discharge readiness. |
| Conventional Anesthesia Group | Active comparator | Procedure: Conventional Anesthesia GroupParticipants assigned to this group will receive standardized conventional general anesthesia with endotracheal intubation and lung-protective mechanical ventilation during cardiac surgery with cardiopulmonary bypass. Extubation or escalation of respiratory and circulatory support will be performed when clinically appropriate. Participants will receive standardized perioperative care and will be assessed using the same predefined physiologic criteria as the experimental group for airway removal and intensive care unit discharge readiness. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older, regardless of sex
- Scheduled to undergo elective cardiac valve surgery with cardiopulmonary bypass
- Considered eligible for either the non-intubated supraglottic airway anesthesia with early restoration of spontaneous breathing (NIA) strategy or the conventional anesthesia strategy, based on a joint preoperative assessment by the anesthesiology and cardiac surgery teams
- Relatively stable vital signs and able to complete the required perioperative assessments and follow-up
- Willing to participate in the study and able to provide written informed consent personally or through a legally authorized representative
Key exclusion criteria (8 listed)
- Emergency or urgent cardiac surgery
- Severe pulmonary infection, severe respiratory failure, or another preoperative condition that clearly precludes use of the NIA strategy
- Severe preoperative hemodynamic instability requiring high-dose vasoactive medications or mechanical circulatory support
- Known difficult airway, high risk of aspiration, or another anesthetic contraindication to the NIA strategy
- Severe hepatic, renal, or neurological disease that may substantially affect the assessment of perioperative outcomes
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 |
|---|---|---|
| Nonintubated Anesthesia GroupA 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 | Nonintubated Anesthesia Group |
| Conventional Anesthesia GroupA 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 |
Primary outcome
Postoperative ICU Length of Stay
Time frame: From the end of surgery until hospital discharge or in-hospital death, assessed up to 90 days after surgery.
Total duration of the initial ICU admission and any ICU readmission during the index hospitalization.
Cumulative Duration of Postoperative Respiratory Support
Time frame: From the end of surgery through postoperative Day 30.
Cumulative Duration of Postoperative Respiratory Support
Number of Participants With One or More Postoperative Pulmonary Complications Within 30 Days After Surgery
Time frame: From the end of surgery through postoperative Day 30.
Number of participants who experience at least one of the following postoperative pulmonary complications within 30 days after surgery: (1) cumulative postoperative invasive mechanical ventilation lasting more than 48 hours, calculated from the end of surgery and including both initial invasive ventilation and invasive ventilation after any subsequent reintubation; (2) unplanned reintubation after the first removal of the study airway because of respiratory failure, failure of airway protection, or another unplanned clinical indication; (3) tracheostomy performed for ongoing respiratory support or airway management; (4) moderate or severe acute respiratory distress syndrome (ARDS), according to the prespecified criteria in the endpoint definition manual; or (5) pneumonia, defined as a new or progressive pulmonary infiltrate together with the prespecified clinical, laboratory, and/or microbiological criteria in the endpoint definition manual.
9 secondary outcomes
Postoperative Multidimensional Recovery Assessed Using Standardized Clinical and Patient-Reported Measures
Time frame: From baseline through postoperative Year 1
Perioperative Anesthetic Medication Requirements
Time frame: From the induction of anesthesia to the end of surgery.
Number of Participants With Postoperative Cardiac Dysfunction
Time frame: From the end of surgery through postoperative Day 30
Number of Participants With Postoperative Acute Kidney Injury
Time frame: From the end of surgery through postoperative Day 7
Number of Participants With Major Postoperative Neurological Complications
Time frame: From the end of surgery through postoperative Day 30
Number of Participants With Major Postoperative Infections
Time frame: From the end of surgery through postoperative Day 30
Number of Participants With Postoperative Hepatic Injury
Time frame: From the end of surgery through postoperative Day 30
Number of Participants With Major Postoperative Bleeding
Time frame: From the end of surgery through postoperative Day 2
Number of Participants Requiring Unplanned Reoperation
Time frame: From the end of surgery through postoperative Day 30
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 7 Aug 2026.
- Individual participant dataSharing planned: Yes. We plan to share de-identified individual participant data (IPD) underlying the results reported in the primary publication of this clinical trial. Shared IPD may include baseline demographic and clinical characteristics, surgical procedure, randomized treatment assignment, anesthesia and airway management, ventilation and respiratory support data, perioperative interventions, protocol adherence and strategy conversion, postoperative pulmonary complications, ICU and hospital outcomes, adverse events, mortality, and other prespecified outcomes during follow-up. The study protocol, statistical analysis plan, data dictionary, and relevant analytic code will also be made available. All direct identifiers will be removed, and dates or potentially identifying variables will be shifted, aggregated, or otherwise processed as necessary to protect participant privacy.
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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 Nonintubated Anesthesia Group and Conventional Anesthesia Group in people with Valve Disease, Heart and CABG, 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 5 inclusion and 8 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 7 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 Doctor (+8615692028041, 1006207119@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative ICU Length of Stay (time frame: From the end of surgery until hospital discharge or in-hospital death, assessed up to 90 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 7 Aug 2026.