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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease; Coronary Artery Bypass Surgery; Ultrasound
• Intervention / Treatment: Diagnostic test: Intraoperative Portable Doppler Ultrasound

• Study Type: Observational
• Enrollment (Estimated): 380

Contacts and Locations

• Study Contact: Name: Zhikang Lv, MD; Phone Number: +8615258021027; Email: lvzhikang1996@163.com
• Study Contact Backup: Name: Qiang Wang, MD; Phone Number: +8615850573193

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Nanjing Drum Tower Hospital, Affiliated Hospital of Nanjing University Medical School
      • Contact: Zhikang Lv, MD; Phone Number: +8615258021027; Email: lvzhikang1996@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Definitive diagnosis of coronary atherosclerotic heart disease, with intention to undergo elective coronary artery bypass grafting (CABG) at this center

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of Major Adverse Clinical Events	Composite of the following events: (1) operative death; (2) perioperative myocardial perfusion adverse events (including perioperative myocardial ischemia or infarction, low cardiac output syndrome); (3) severe neurological complications (including stroke or persistent postoperative neurological deficit); (4) acute kidney injury requiring temporary or permanent dialysis; (5) postoperative need for mechanical circulatory support (e.g., IABP or ECMO); (6) unplanned cardiac reoperation (excluding reoperation for bleeding alone); (7) postoperative cardiac arrest, multiple organ failure, or mechanical ventilation > 72 hours; (8) postoperative hospital stay ≥ 30 days.	From surgery up to 30 days postoperatively
Composite of Ultrasound-Detected Graft Perfusion Abnormalities	Composite of the following events: (1) significantly diminished or absent flow signal in the graft by portable ultrasound; (2) new segmental wall motion abnormality in the distal myocardial territory supplied by the graft; (3) new or worsening decline in left ventricular systolic function (LVEF decrease ≥ 10% from baseline); (4) intraoperative graft repositioning, re-anastomosis, or early postoperative interventional/surgical intervention due to ultrasound-indicated graft perfusion or functional abnormality. Any one of the above events constitutes this composite endpoint.	Intraoperative and up to 30 days postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Longitudinal Changes in Routine Hematology Parameters	Change from baseline over time in complete blood count parameters, including white blood cell count (×10⁹/L) and neutrophil percentage (%). Blood samples will be collected at each time point and analyzed according to standardized laboratory procedures.	Preoperatively, and at postoperative days 1, 2, 3, 7, 10, 30, and 90
Longitudinal Changes in Inflammatory Biomarkers	Change from baseline over time in serum inflammatory markers, including C-reactive protein (CRP, mg/L), interleukin-6 (IL-6, pg/mL), and procalcitonin (PCT, ng/mL). Blood samples will be collected at each time point and analyzed according to standardized laboratory procedures.	Preoperatively, and at postoperative days 1, 2, 3, 7, 10, 30, and 90
Longitudinal Changes in Coagulation and Platelet Function Parameters	Change from baseline over time in coagulation function, including prothrombin time (PT, seconds), activated partial thromboplastin time (aPTT, seconds), platelet count (×10⁹/L), and platelet function. Blood samples will be collected at each time point and analyzed according to standardized laboratory procedures.	Preoperatively, and at postoperative days 1, 2, 3, 7, 10, 30, and 90
Longitudinal Changes in Hepatic Function Parameters	Change from baseline over time in serum hepatic function markers, including alanine aminotransferase (ALT, U/L), aspartate aminotransferase (AST, U/L), lactate dehydrogenase (LDH, U/L), total bilirubin (μmol/L), and direct bilirubin (μmol/L). Blood samples will be collected at each time point and analyzed according to standardized laboratory procedures.	Preoperatively, and at postoperative days 1, 2, 3, 7, 10, 30, and 90
Longitudinal Changes in Renal Function Parameters	Change from baseline over time in serum renal function markers, including serum creatinine (μmol/L), uric acid (μmol/L), and estimated glomerular filtration rate (eGFR, mL/min/1.73m²). Blood samples will be collected at each time point and analyzed according to standardized laboratory procedures.	Preoperatively, and at postoperative days 1, 2, 3, 7, 10, 30, and 90
Longitudinal Changes in Myocardial Injury and Cardiac Function Biomarkers	Change from baseline over time in serum myocardial injury and cardiac function markers, including high-sensitivity troponin T (hs-cTnT, ng/mL), B-type natriuretic peptide (BNP, pg/mL), creatine kinase (CK, U/L), and creatine kinase-MB isoenzyme (CK-MB, U/L). Blood samples will be collected at each time point and analyzed according to standardized laboratory procedures.	Preoperatively, and at postoperative days 1, 2, 3, 7, 10, 30, and 90
Intraoperative and Perioperative Surgical Parameters and Complications	Intraoperative parameters including cardiopulmonary bypass time (minutes), aortic cross-clamp time (minutes), and total surgical time (minutes). Perioperative parameters including postoperative length of hospital stay (days), chest tube drainage volume (mL) and characteristics, postoperative blood transfusion requirement and volume (mL), and incidence of perioperative complications including sternal wound infection, secondary debridement, reintubation, pneumonia, and delirium.	Intraoperatively and during index hospital stay
Ultrasound-Derived Graft Flow Parameters and Diagnostic Accuracy	Intraoperative portable ultrasound parameters of distal graft perfusion and myocardial perfusion, including graft flow signals. These will be compared with postoperative conventional transthoracic echocardiography or other imaging modalities to evaluate the diagnostic accuracy and consistency of intraoperative ultrasound in assessing graft patency and distal perfusion status.	Intraoperative and at 30-day postoperative follow-up

Collaborators and Investigators

• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): February 28, 2029

Study Registration Dates

• First Submitted: July 7, 2026
• First Submitted That Met QC Criteria: July 7, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 7, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: NJGH-CABG-US2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No