Development and Clinical Validation of a Smart Analysis System for a Wearable Cardiac Ultrasound Device
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 600
- 主要终点
- Mean Difference in LVEF Measurements Between Wearable Cardiac Ultrasound and Standard Bedside Echocardiography
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Wearable Cardiac Ultrasound Monitoring
Participants will undergo continuous cardiac structure and function monitoring with the wearable cardiac ultrasound system. They will also receive standard bedside echocardiography as routine clinical care. The study team will compare measurements from the wearable device with results from standard echocardiography to evaluate the accuracy and consistency of the wearable system.
干预措施: Wearable Cardiac Ultrasound System (Device)
结局指标
主要结局
Mean Difference in LVEF Measurements Between Wearable Cardiac Ultrasound and Standard Bedside Echocardiography
时间窗: Day 1
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.
次要结局
未报告次要终点
研究者
Kunjing Pang
Principal Investigator
China National Center for Cardiovascular Diseases