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

Официальное название

Clinical Application of Intraoperative Portable Ultrasound for Real-Time Distal Graft Perfusion Monitoring During Coronary Artery Bypass Grafting: A Single-Center, Randomized, Controlled Trial

Обзор

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.

Вмешательства

• Диагностический тест Intraoperative Portable Doppler Ultrasound
  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.

Первичные конечные точки

• Composite of Major Adverse Clinical Events [Срок оценки: From surgery up to 30 days postoperatively]
• Composite of Ultrasound-Detected Graft Perfusion Abnormalities [Срок оценки: Intraoperative and up to 30 days postoperatively]

Вторичные конечные точки (8)

• Longitudinal Changes in Routine Hematology Parameters [Срок оценки: Preoperatively, and at postoperative days 1, 2, 3, 7, 10, 30, and 90]
• Longitudinal Changes in Inflammatory Biomarkers [Срок оценки: Preoperatively, and at postoperative days 1, 2, 3, 7, 10, 30, and 90]
• Longitudinal Changes in Coagulation and Platelet Function Parameters [Срок оценки: Preoperatively, and at postoperative days 1, 2, 3, 7, 10, 30, and 90]
• Longitudinal Changes in Hepatic Function Parameters [Срок оценки: Preoperatively, and at postoperative days 1, 2, 3, 7, 10, 30, and 90]
• Longitudinal Changes in Renal Function Parameters [Срок оценки: Preoperatively, and at postoperative days 1, 2, 3, 7, 10, 30, and 90]
• Longitudinal Changes in Myocardial Injury and Cardiac Function Biomarkers [Срок оценки: Preoperatively, and at postoperative days 1, 2, 3, 7, 10, 30, and 90]
• Intraoperative and Perioperative Surgical Parameters and Complications [Срок оценки: Intraoperatively and during index hospital stay]
• Ultrasound-Derived Graft Flow Parameters and Diagnostic Accuracy [Срок оценки: Intraoperative and at 30-day postoperative follow-up]

Критерии участия

Inclusion criteria: 1. Age ≥18 years; 2. Definitive diagnosis of coronary atherosclerotic heart disease, with intention to undergo elective coronary artery bypass grafting (CABG) at this center; 3. Able to perform real-time ultrasound blood flow measurement before and after bypass grafting during the operation, and obtain relevant blood flow parameters of the left anterior descending artery, left circumflex artery, right coronary artery, and bypass graft; 4. The subject or his/her legal guardian provides informed consent and signs a written informed consent form.

Exclusion criteria: 1. Patients undergoing emergency surgery, rescue surgery, or unable to complete standardized measurements according to the study protocol; 2. Patients with significant preoperative hemodynamic instability requiring intra-aortic balloon counterpulsation, extracorporeal membrane oxygenation, or other mechanical circulatory support; 3. Patients requiring concomitant valve surgery, major vascular surgery, or other complex cardiac surgeries; 4. Patients scheduled for or undergoing sequential coronary artery bypass grafting; 5. Patients unable to complete effective echocardiographic measurements due to severe adhesion, poor anatomical conditions, limited surgical field exposure, or other technical reasons during the operation; 6. Patients with severe arrhythmias, severe cardiac dysfunction, or other conditions that may significantly affect the accuracy of intraoperative blood flow measurements; 7. Patients with severe preoperative liver, kidney, lung, or other vital organ failure that may significantly affect the evaluation of study endpoints; 8. Patients lacking key baseline data before surgery or expected to be unable to complete follow-up of primary endpoint indicators after surgery; 9. Pregnant or lactating women; 10. Other situations deemed unsuitable for inclusion in this study by the investigator.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Nanjing Drum Tower Hospital, Affiliated Hospital of Nanjing University Medical School — Нанкин

Идентификаторы

NCT: NCT07700524 · NJGH-CABG-US2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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