Intraoperative Portable Ultrasound for Real-Time Graft Perfusion Assessment During CABG: A Randomized Controlled Trial

Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study ID
NCT07700524
Status
Not Yet Recruiting

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Conditions

  • Coronary Artery Bypass Surgery
  • Coronary Artery Disease
  • Ultrasound

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intraoperative Portable Doppler Ultrasound — DIAGNOSTIC_TEST
    Intraoperative real-time assessment of distal graft perfusion and each coronary artery perfusion using a portable ultrasound device before and after completion of coronary artery bypass anastomosis. Ultrasound parameters are recorded for each artery. The procedure is performed by trained surgeons or researchers. In case of any ultrasound-related adverse event or safety concern, the assessment is terminated immediately.

Study Details

This single-center, randomized, controlled trial aims to evaluate whether intraoperative portable ultrasound monitoring can improve early postoperative outcomes in patients undergoing coronary artery bypass grafting (CABG). A total of 380 patients scheduled for elective CABG at Nanjing Drum Tower Hospital will be randomly assigned in a 1:1 ratio to either the ultrasound group or the control group. In the ultrasound group, a trained surgeon or researcher will use a portable ultrasound device to assess distal graft perfusion and each coronary artery perfusion in real time before and after completion of graft anastomosis. In the control group, graft function is evaluated by the surgeon's standard clinical judgment without ultrasound monitoring. The primary outcomes are two composite endpoints: (1) a composite of major adverse clinical events including operative death, perioperative myocardial ischemia or infarction, low cardiac output syndrome, stroke, acute kidney injury requiring dialysis, need for mechanical circulatory support, unplanned cardiac reoperation, cardiac arrest, multiorgan failure, prolonged mechanical ventilation (\>72 hours), and postoperative hospital stay ≥30 days; and (2) a composite of ultrasound-detected graft perfusion abnormalities including diminished or absent graft flow signal, new segmental wall motion abnormalities, decline in left ventricular ejection fraction (LVEF) ≥10% from baseline, and graft-related reintervention. Secondary outcomes include longitudinal changes in laboratory biomarkers (hematology, inflammation, coagulation, liver and renal function, myocardial injury, and cardiac function), intraoperative and perioperative surgical parameters, and diagnostic accuracy of ultrasound compared with postoperative imaging. All participants will receive standard CABG surgery and perioperative care. Results are expected to provide evidence on the clinical utility of intraoperative ultrasound for real-time perfusion assessment during CABG.

Key Dates

First listed
Jul 14, 2026
Start date
Aug 1, 2026
Status verified
Jul 2026
Primary completion
Feb 28, 2028
Completion
Feb 28, 2029

Study Design

Enrollment
380 participants (estimated)

Arms

  • Arm: Portable Ultrasound Real-time Monitoring Group
    After completion of graft anastomosis, a trained surgeon or researcher uses a portable ultrasound device to perform real-time assessment of distal graft perfusion, each coronary artery perfusion and records relevant ultrasound parameters. If any potential adverse event related to ultrasound operation or any obvious interference with surgical safety occurs, the ultrasound assessment will be immediately terminated, the subject will be withdrawn from the study, and the event will be documented and reported according to regulations. This arm enrolls 190 patients.
  • Arm: Conventional Surgery Control Group
    Patients in this arm do not receive intraoperative portable ultrasound assessment. Graft function is evaluated solely by the surgeon's experience and routine intraoperative methods (e.g., palpation, flow measurement) as per standard practice. All other surgical procedures and perioperative management are identical to those in the experimental group. This arm enrolls 190 patients.

Primary Outcome Measure

Composite of Major Adverse Clinical Events [ Time Frame: From surgery up to 30 days postoperatively ]

Central Contacts

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