Wearable Ultrasound for Cardiac Monitoring During Surgery and in Intensive Care

NCT07891052 | Not Yet Recruiting

• 1 other identifier: 2026-3139
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1

Study Arms (1)

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.

Device: Wearable Ultrasound Imaging System

Interventions

Wearable Ultrasound Imaging System DEVICE

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.

Wearable Ultrasound Monitoring

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

MeSH Terms

Conditions

Cardiovascular Diseases

Central Study Contacts

Kunjing Pang

CONTACT

86+13520114557; pangkunjing2020@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 15, 2026
• First Posted: October 23, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: October 23, 2026

Record last verified: 2026-10