Handheld ultrasound could spot hidden graft failures during bypass surgery

NCT ID NCT07700524

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Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
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When the status isn't known

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First seen Jul 14, 2026 · Last updated Aug 12, 2026 · Updated 3 times

Summary

This trial tests whether using a portable ultrasound device during coronary artery bypass surgery can improve outcomes by letting surgeons see blood flow through the new grafts in real time. About 380 adults scheduled for elective bypass surgery will be randomly assigned to either standard care or standard care plus ultrasound monitoring. The study will compare rates of major complications like heart attack, stroke, kidney failure, and death, as well as how often ultrasound detects graft problems that need fixing.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
intraoperative portable Doppler ultrasound
What this could lead to
If successful, this approach could become a standard tool during bypass surgery to catch and fix blood flow problems immediately, potentially reducing complications.
What could go wrong
This is a single-center trial with 380 patients, so results may not apply to all hospitals. The ultrasound adds time and training, and its benefit over standard surgical judgment is unproven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 190 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population will consist of adults undergoing elective isolated coronary artery bypass grafting in the Department of Cardiac Surgery at Nanjing Drum Tower Hospital. Consecutive patients meeting the eligibility criteria will be screened and enrolled after providing written informed consent.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Aged 18 years or older. * Confirmed coronary artery disease and scheduled to undergo elective isolated coronary artery bypass grafting at Nanjing Drum Tower Hospital. * Able and willing to provide written informed consent before any study-specific procedures are performed. Exclusion Criteria: * Urgent, emergency, or salvage coronary artery bypass grafting. * Prolonged preoperative fasting, as defined in the study protocol, or inability to maintain adequate oral intake without enteral or parenteral nutritional support. * History of malignancy. * Body weight below 50 kg. * Preoperative hemodynamic instability requiring ongoing resuscitation or mechanical circulatory support, including intra-aortic balloon pump, extracorporeal membrane oxygenation, or left ventricular assist device support. * Endotracheal intubation and invasive mechanical ventilation before surgery. * Impaired consciousness, clinically significant central nervous system dysfunction, or evidence of cerebral malperfusion after hospital admission. * End-stage renal disease requiring maintenance dialysis before hospital admission. * Severe pulmonary disease considered to preclude tolerance of elective coronary artery bypass grafting or to confer an unacceptably high perioperative risk. * Severe peripheral vascular disease or clinical evidence of limb malperfusion before surgery. * History of gastrointestinal ulceration or chronic inflammatory gastrointestinal disease. * Chronic inflammatory or autoimmune disease, or long-term treatment with systemic corticosteroids or non-steroidal anti-inflammatory drugs. * Active infection or sepsis at screening. * Severe uncontrolled arrhythmia requiring urgent treatment or expected to cause marked intraoperative hemodynamic instability. * Previous cardiac surgery requiring repeat median sternotomy. * Planned concomitant major cardiac or aortic surgery, including valve surgery, congenital heart defect repair, or aortic surgery. * Inability to understand the study information or unwillingness or inability to provide written informed consent. * Inability or unwillingness to complete follow-up at 30 ± 7 days after surgery. * Pregnancy or breastfeeding.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

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

    Nanjing, Jiangsu, 210008, China

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