NCT07744009 Nonintubated Anesthesia for Adult Cardiac Surgery With Cardiopulmonary Bypass

Eligibility & Interventions

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This trial targets 300 participants in total. It began in 2026-07-21 with a primary completion date of 2028-07-30.

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.

Eligibility Criteria

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

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