Nonintubated anesthesia for adults undergoing cardiac surgery with bypass

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this multicenter randomized trial, adults undergoing elective cardiac surgery with cardiopulmonary bypass are assigned to either a nonintubated supraglottic airway strategy with early spontaneous breathing or a conventional endotracheal fast-track anesthesia. The study compares the two approaches on outcomes such as pulmonary complications within 30 days, need for invasive breathing support after surgery, and length of ICU stay. Approximately 400 participants will be enrolled and followed in parallel groups at multiple centers. Safety and recovery measures will also be recorded to assess overall perioperative outcomes. The trial aims to determine if reducing endotracheal intubation is feasible and beneficial in this surgical population.

Why it matters

Who can join: the full rules

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

Where it's running

• The First Affiliated Hospital of Guangzhou Medical University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Haoxiang Yuan Doctor
• Email: 1006207119@qq.com
• Phone: +8615692028041

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.