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Wearable Ultrasound for Cardiac Monitoring During Surgery and in Intensive Care
Sponsor: China National Center for Cardiovascular Diseases
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). 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. 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.
Official title: Development of a Wearable Ultrasound Imaging System and Its Application in Intraoperative Cardiac Monitoring and Cardiopulmonary Monitoring in Critical Care
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
600
Start Date
2026-11
Completion Date
2028-12
Last Updated
2026-10-23
Healthy Volunteers
No
Conditions
Interventions
Wearable Ultrasound Imaging System
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.