Nonintubated Anesthesia for Adult Cardiac Surgery With Cardiopulmonary Bypass

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.

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