Nonintubated Anesthesia for Adult Cardiac Surgery With Cardiopulmonary Bypass
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of Guangzhou Medical University
About this 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.
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Nonintubated Anesthesia Group
Procedure/SurgeryA 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 Group
Procedure/SurgeryA 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.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Nonintubated Anesthesia GroupExperimental treatment 1 intervention
Group B: Conventional Anesthesia GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.2
Cumulative Duration of Postoperative Respiratory Support
Cumulative Duration of Postoperative Respiratory Support
Time frame
From the end of surgery through postoperative Day 30.3
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.Secondary outcomes
1
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 12
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.3
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 304
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 7Sponsors and contacts
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Source ClinicalTrials.gov