RecruitingACTRN12619000137190

Three-stages assessment of coronary artery bypass grafts patency by intraoperative transit time flow measurement

Evaluation of coronary artery bypass grafts by intraoperative transit time flow measurement in three stages; on the resting heart, on beating heart, after heparin inactivation.

Sponsor

Federal State Budgetary Scientific Institution “Tomsk National Research Medical Center of the Russian Academy of Sciences”

Enrollment

300 participants

Start Date

Feb 1, 2019

Study Type

Interventional

Conditions

Coronary artery bypass grafting patency

Summary

Intraoperative graft failure is a potentially avoidable major cause of cardiac morbidity and mortality and occurs in up to 3% of grafts (8% of patients) after coronary artery bypass grafting. At present, transit-time flow measurement (TTFM) is the most common intraoperative method for assessing graft function. Our randomized study using the VeriQ system allows to verify the adequacy of the grafts patency at all stages of the operation. In this way the TTFM values of all grafts were recorded intra-operatively in three stages: 1. Immediately after performing of the all distal anastomoses (with proximal snare on target corfonary artery and without it), 2. after the patient was weaned from cardiopulmonary bypass and the hemodynamic condition was assessed as being stable, 3. after heparin inactivation, before chest closure. This allows to control the grafts functionality after performing of each anastomosis and correct the surgical error immediately, without restoring repeat cardiac arrest.

Eligibility

Sex: Both males and femalesMin Age: 40 Yearss

Plain Language Summary

Simplified for easier understanding

During coronary artery bypass graft (CABG) surgery, surgeons create new routes for blood to flow around blocked coronary arteries using vessels taken from elsewhere in the body. It is essential that these grafts function properly immediately after surgery. Transit-time flow measurement (TTFM) is a technique used during surgery to check that the grafts are working, but the timing and protocol for when to check varies. This study tests a three-stage assessment approach — checking graft blood flow at three specific points during the operation — to improve early detection of graft problems before the chest is closed. The goal is to identify and fix any surgical errors in real time rather than discovering problems after the fact. You may be eligible if you are 40 or older and are scheduled for elective coronary artery bypass graft surgery due to coronary artery disease, and have normal kidney function. You are not eligible if you are also having valve surgery or aortic surgery at the same time, or if your surgery is combined with other major procedures.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

A randomized study comparing two groups of patients undergoing coronary artery bypass grafting (CABG) at our institute, where patient first group underwent transit time flow measurements (TTFM) of all bypass grafts using the VeriQ system (MediStim Inc., Oslo, Norway). The TTFM values of all grafts were recorded intra-operatively in three stages: 1. Immediately after performing of the all distal anastomoses (with proximal snare on target corfonary artery and without it), 2. after the patient was weaned from cardiopulmonary bypass and the hemodynamic condition was assessed as being stable, 3. after heparin inactivation, before chest closure. Materials: Two hundred patients listed for CABG Procedures: All CABGs were performed through a median sternotomy during cardiopulmonary bypass. Full heparinization was given. Who: heart surgeon with 10 years experience Mode of delivery: face to face Number of times: twice / week

Locations(1)

Russian Federation

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