Development and Clinical Validation of a Smart Analysis System for a Wearable Cardiac Ultrasound Device

N/ANot Yet RecruitingNCT07825246

Kunjing Pang600 enrolled

Overview

The goal of this observational study is to learn if a wearable heart ultrasound system with automated analysis works as well as standard bedside ultrasound for continuous heart function monitoring in adults and children with severe heart conditions in intensive care units (ICUs). The study will also test if the system can help guide minimally invasive procedures for structural heart defects. About 610 people will take part in this research. The main questions it aims to answer are: * Do heart function measurements from the wearable ultrasound system match results from standard bedside ultrasound exams? * How accurately can the automated analysis tool measure heart function using images from the wearable device? * Is it feasible and safe to use the wearable ultrasound system to help guide minimally invasive closure of heart defects? Researchers will compare readings collected by the wearable ultrasound device to results from standard bedside ultrasound exams. They will check how closely the two methods agree to see if the wearable system can replace standard testing for ongoing heart monitoring. The research team will remove all personal identifiers from all study data to protect each participant's privacy. Participants will: * Wear a small, soft ultrasound patch on their chest to continuously monitor their heart structure and function * Receive standard bedside ultrasound exams as part of their routine intensive care * Allow the research team to collect their heart images and vital signs (heart rate, blood pressure, and oxygen levels) for study analysis * If they receive a minimally invasive procedure to fix a heart defect, the research team will use the wearable ultrasound device during the procedure to help guide treatment

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

600

Interventions

Wearable Cardiac Ultrasound SystemDEVICE

A soft, wearable ultrasound patch is applied to the participant's chest to continuously acquire cardiac ultrasound images. The system performs real-time 2D echocardiographic imaging, Doppler assessment, and automated cardiac function measurement. Ultrasound data is transmitted wirelessly for remote review by experienced sonographers, and synchronized with bedside vital sign monitors. Study staff compare measurements from the wearable system with results from standard bedside echocardiography to evaluate consistency and accuracy.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients with perioperative cardiopulmonary critical illness admitted to the adult ICU or CCU at Fuwai Hospital, including patients with coronary artery disease or valvular heart disease after cardiac surgery, and patients undergoing interventional procedures for structural heart disease. * Pediatric patients with perioperative cardiopulmonary critical illness admitted to the pediatric intensive care unit (PICU) at Fuwai Hospital, including patients with congenital heart disease after cardiac surgery. Exclusion Criteria: * Severe wound infection or delayed thoracic closure that prevents placement of the wearable cardiac ultrasound monitoring device. * Patient or family refusal to participate in the study.

Outcomes

Primary Outcomes

Mean Difference in LVEF Measurements Between Wearable Cardiac Ultrasound and Standard Bedside Echocardiography

LVEF (%) measured from wearable cardiac ultrasound images will be compared with LVEF (%) measured by an experienced echocardiographer using standard bedside echocardiography. The primary outcome is the mean difference in LVEF between the two methods, calculated as wearable cardiac ultrasound minus standard bedside echocardiography. The mean difference and its 95% confidence interval will be calculated. Bland-Altman analysis will also be performed to estimate the 95% limits of agreement between the two methods.

Time frame: Day 1