CABG, Valve Disease, Heart
Conditions
Keywords
Enhanced recovery after surgert, cardiac surgery
Brief 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 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.
Interventions
PROCEDURENonintubated 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.
PROCEDUREConventional Anesthesia Group
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.
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Participants will be randomly assigned in a 1:1 ratio to one of two parallel perioperative anesthesia strategy groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative ICU Length of Stay | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Multidimensional Recovery Assessed Using Standardized Clinical and Patient-Reported Measures | From baseline through postoperative Year 1 | 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. |
| Perioperative Anesthetic Medication Requirements | From the induction of anesthesia to the end of surgery. | 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. |
| Number of Participants With Postoperative Cardiac Dysfunction | From the end of surgery through postoperative Day 30 | participants who develop new or worsening postoperative low cardiac output syndrome |
| Number of Participants With Postoperative Acute Kidney Injury | From the end of surgery through postoperative Day 7 | Acute kidney injury diagnosed based on the KDIGO criteria after surgery |
| Number of Participants With Major Postoperative Neurological Complications | From the end of surgery through postoperative Day 30 | Number of participants who experience at least one major postoperative neurological complication, including stroke, transient ischemic attack, persistent coma, or an unprovoked seizure. |
| Number of Participants With Major Postoperative Infections | From the end of surgery through postoperative Day 30 | surgical-site infection, pneumonia, bloodstream infection, urinary tract infection, or mediastinitis. |
| Number of Participants With Postoperative Hepatic Injury | From the end of surgery through postoperative Day 30 | 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. |
| Number of Participants With Major Postoperative Bleeding | From the end of surgery through postoperative Day 2 | 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. |
| Number of Participants Requiring Unplanned Reoperation | From the end of surgery through postoperative Day 30 | 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. |
Countries
China
Contacts
CONTACTHaoxiang Yuan Doctor
Outcome results
None listed