An interventional study of Nonintubated Anesthesia Group and Conventional Anesthesia Group in Valve Disease, Heart and CABG, sponsored by The First Affiliated Hospital of Guangzhou Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by The First Affiliated Hospital of Guangzhou Medical University · Not applicable, Interventional, and Treatment
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.
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.
535 studies on the registry are indexed under Heart Valve Diseases; 172 are open to participants now.
This study's planned enrollment of 300 is above the median of 100 across 290 interventional studies indexed under Heart Valve Diseases.
Browse Heart Valve Diseases studies →The First Affiliated Hospital of Guangzhou Medical University is the lead sponsor of 158 studies on the registry; 65 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Procedure: Nonintubated Anesthesia Group
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.
Procedure: Conventional Anesthesia Group
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.
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.
Postoperative ICU Length of Stay
Total duration of the initial ICU admission and any ICU readmission during the index hospitalization.
Time frame: 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
Time frame: 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.
Time frame: From the end of surgery through postoperative Day 30.
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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From the end of surgery through postoperative Day 30
Plan to share: 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.
Supporting information: Study protocol
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The First Affiliated Hospital of Guangzhou Medical University