Nonintubated Anesthesia for Adult Cardiac Surgery With Cardiopulmonary Bypass

Overview

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.