Cardiovascular DiseasesNCT07891052
Wearable Ultrasound for Cardiac Monitoring During Surgery and in Intensive Care
A study testing Wearable Ultrasound Imaging System in people with Cardiovascular Diseases, run by China National Center for Cardiovascular Diseases.
Trial summary
This study aims to evaluate the accuracy, feasibility, and clinical usefulness of a wearable ultrasound imaging system for cardiac monitoring during perioperative care and in intensive care units (ICUs). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Wearable Ultrasound Imaging System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients of any age, including neonates, receiving care in the adult intensive care unit (ICU), coronary care unit (CCU), or pediatric intensive care unit (PICU) at Fuwai Hospital. There are no minimum or maximum age restrictions.
- Patients with severe cardiovascular conditions requiring perioperative cardiac or cardiopulmonary intensive care.
- Written informed consent provided by the patient or the patient's parent or legal guardian.
Who cannot join
- Unable to cooperate with or complete the wearable echocardiography examination.
- Poor transthoracic echocardiographic image quality that prevents acquisition of standard cardiac views.
- Severe wound infection that prevents placement of the wearable ultrasound device.
- Delayed sternal closure that prevents placement of the wearable ultrasound device.
- Patient or parent or legal guardian declines participation in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Development of a Wearable Ultrasound Imaging System and Its Application in Intraoperative Cardiac Monitoring and Cardiopulmonary Monitoring in Critical Care
This study aims to evaluate the accuracy, feasibility, and clinical usefulness of a wearable ultrasound imaging system for cardiac monitoring during perioperative care and in intensive care units (ICUs).
Traditional bedside echocardiography provides important information about heart structure and function but is usually performed intermittently. Wearable ultrasound technology may allow more frequent monitoring of cardiac function and help healthcare professionals recognize changes in patients' conditions.
Read more
This prospective device-comparison study plans to enroll 600 patients, including 400 adults and 200 children, receiving care in cardiac intensive care settings at Fuwai Hospital.
Participants will undergo cardiac monitoring using a wearable ultrasound imaging system in addition to conventional bedside echocardiography. The wearable device will obtain cardiac ultrasound images that can be transmitted wirelessly for remote assessment by physicians. Under stable clinical conditions, ultrasound assessments will generally be performed hourly, with additional assessments when significant circulatory changes occur. Conventional bedside echocardiography will be performed daily for comparison.
The study will compare measurements of cardiac structure and function obtained using the two methods, including left ventricular ejection fraction (LVEF), and evaluate their agreement and ability to identify clinically important cardiovascular changes.
In a subgroup of 400 participants (300 adults and 100 children), wearable ultrasound images will also be displayed alongside electrocardiography, blood pressure, and oxygen saturation measurements on bedside monitors to evaluate the feasibility and potential clinical benefits of integrated monitoring.
The findings may help determine whether wearable ultrasound technology can provide accurate and practical cardiac monitoring for critically ill patients.
- Conditions
- Cardiovascular Diseases
- Being tested
- Wearable Ultrasound Imaging System
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable Ultrasound Imaging SystemDevice
A wearable ultrasound transducer will be positioned on the chest by an experienced sonographer to obtain cardiac images, primarily the apical four-chamber view. Images will be transmitted wirelessly for remote review. Two-dimensional, color Doppler, spectral Doppler, and M-mode imaging will be used to assess cardiac structure and function, including left ventricular ejection fraction (LVEF). Ultrasound assessments will generally be performed hourly under stable clinical conditions and additionally when significant circulatory changes occur. All participants will also undergo routine daily bedside echocardiography for comparison. In a subgroup of 400 participants (300 adults and 100 children), wearable ultrasound images will be displayed alongside electrocardiography, blood pressure, and oxygen saturation measurements on bedside monitors.
| Study group | Role | What they receive |
|---|---|---|
| Wearable Ultrasound Monitoring | Experimental | All participants will undergo cardiac monitoring using a wearable ultrasound imaging system in addition to conventional bedside echocardiography. Wearable ultrasound assessments will generally be performed hourly under stable clinical conditions and additionally when significant circulatory changes occur. Conventional bedside echocardiography will be performed daily for comparison. A subgroup of 400 participants will also undergo integrated monitoring combining wearable ultrasound with electrocardiography, blood pressure, and oxygen saturation measurements. Receives: Device: Wearable Ultrasound Imaging System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement in Left Ventricular Ejection Fraction Measurements
Agreement between left ventricular ejection fraction (LVEF) measurements obtained using wearable ultrasound and conventional bedside echocardiography will be assessed using the intraclass correlation coefficient (ICC). Paired measurements will be used to evaluate the consistency of the two methods.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kunjing Pang, China National Center for Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07891052
- Sponsor's protocol ID
- 2026-3139
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No