Nonintubated Anesthesia for Adult Cardiac Surgery With Cardiopulmonary Bypass

NCT07744009 | Recruiting

• 1 other identifier: GMUFAH-NIACardiac-2026
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Valve Disease, Heart; CABG

Keywords

Enhanced recovery after surgert; cardiac surgery

Outcome Measures

Primary Outcomes (3)

• Postoperative ICU Length of Stay

  Total duration of the initial ICU admission and any ICU readmission during the index hospitalization.

  From the end of surgery until hospital discharge or in-hospital death, assessed up to 90 days after surgery.

• Cumulative Duration of Postoperative Respiratory Support

  Cumulative Duration of Postoperative Respiratory Support

  From the end of surgery through postoperative Day 30.

• Number of Participants With One or More Postoperative Pulmonary Complications Within 30 Days After Surgery

  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.

  From the end of surgery through postoperative Day 30.

Secondary Outcomes (9)

• Postoperative Multidimensional Recovery Assessed Using Standardized Clinical and Patient-Reported Measures

  From baseline through postoperative Year 1

• Perioperative Anesthetic Medication Requirements

  From the induction of anesthesia to the end of surgery.

• Number of Participants With Postoperative Cardiac Dysfunction

  From the end of surgery through postoperative Day 30

• Number of Participants With Postoperative Acute Kidney Injury

  From the end of surgery through postoperative Day 7

• Number of Participants With Major Postoperative Neurological Complications

  From the end of surgery through postoperative Day 30

Study Arms (2)

Nonintubated Anesthesia Group

EXPERIMENTAL

Participants assigned to this group will receive a standardized nonintubated supraglottic airway anesthesia strategy with early restoration of spontaneous breathing during cardiac surgery with cardiopulmonary bypass. Endotracheal intubation or escalation of respiratory and circulatory support will be performed when clinically necessary. Participants will receive standardized perioperative care and will be assessed using predefined physiologic criteria for airway removal and intensive care unit discharge readiness.

Procedure: Nonintubated Anesthesia Group

Conventional Anesthesia Group

ACTIVE COMPARATOR

Participants assigned to this group will receive standardized conventional general anesthesia with endotracheal intubation and lung-protective mechanical ventilation during cardiac surgery with cardiopulmonary bypass. Extubation or escalation of respiratory and circulatory support will be performed when clinically appropriate. Participants will receive standardized perioperative care and will be assessed using the same predefined physiologic criteria as the experimental group for airway removal and intensive care unit discharge readiness.

Procedure: Conventional Anesthesia Group

Interventions

Nonintubated Anesthesia Group PROCEDURE

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.

Nonintubated Anesthesia Group

Conventional Anesthesia Group PROCEDURE

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.

Conventional Anesthesia Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 450051, China

RECRUITING

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Haoxiang Yuan Doctor

CONTACT

+8615692028041; 1006207119@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician and Professor of Thoracic Surgery

Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two parallel perioperative anesthesia strategy groups.

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 4, 2026
• Study Start: July 21, 2026
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 7, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning at study completion and ending 5 years after study completion.
• Access Criteria: De-identified IPD and supporting documents (study protocol, statistical analysis plan, and data dictionary) will be available to qualified researchers outside the primary study group for scientifically sound research purposes. Access will be granted upon submission of a written request that includes a brief research proposal, analysis plan, and proof of relevant ethics/IRB review if applicable. Requests will be reviewed by the study steering committee/data access committee. Approved requestors must sign a data use agreement prohibiting re-identification attempts and onward sharing, and requiring appropriate data security measures and acknowledgement of the original study. Data will be provided through a secure electronic transfer or a controlled-access online repository; access instructions will be provided after approval.

Locations

CN (1)