Nonintubated Anesthesia for Adult Cardiac Surgery With Cardiopulmonary Bypass

Condition(s) studied

Investigational drug(s) / intervention(s)

Nonintubated 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.

Conventional 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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (1)

More The First Affiliated Hospital of Guangzhou Medical University trials in China

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