跳至主要内容
临床试验/NCT07466056
NCT07466056招募中不适用

Application of Non-inductive Intelligent Physical Sign Monitoring Equipment Based on Flexible Electronic Devices in the Diagnosis and Treatment of Cardiovascular Diseases

Beijing Anzhen Hospital1 个研究点 分布在 1 个国家目标入组 1,100 人开始时间: 2024年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,100
试验地点
1
主要终点
Heart Rate and Heart Rhythm

研究概览

简要总结

This project is a single-center clinical evaluation study designed to validate a non-invasive mattress-based smart monitoring system. The system is intended for installation on standard hospital beds to provide continuous, contact-free monitoring of vital signs, including heart rate, respiration, body temperature, and posture, in patients with cardiovascular diseases. The system will integrate monitoring data with hospital information systems and personal health platforms to support clinical management and remote health monitoring.

详细描述

In the diagnosis, treatment, and rehabilitation of cardiovascular diseases, accurate monitoring of key physiological signs provides the fundamental basis for clinicians to assess patient status and formulate treatment strategies. Traditional monitoring instruments used to acquire physiological data, such as electrocardiogram (ECG) monitors and polysomnography systems, require physical connections through electrode leads or ECG patches, which may increase patient discomfort and the risk of adverse events. Therefore, the development of monitoring devices with non-invasive and multi-parameter sensing capabilities is of significant importance for clinical care, nursing practice, and long-term health management.

This project focuses on the development and clinical evaluation of a non-invasive intelligent monitoring device for human physiological signals. The device is designed in the form of a mattress installed on a conventional hospital bed to enable real-time, accurate, continuous, and non-invasive monitoring of important physiological parameters in cardiovascular patients, including heart rate, respiration, body temperature, and body posture. Monitoring data will be integrated with hospital information systems and patient-side digital platforms to support clinical decision-making, disease management, and remote health monitoring.

A clinical evaluation will be conducted prior to product commercialization to determine whether the monitoring performance of the mattress-based system is non-inferior to that of conventional bedside ECG monitoring systems. Large-scale, long-term, and continuous physiological data from cardiovascular patients will be collected and analyzed in real-world clinical settings. Advanced technologies, including artificial intelligence and cloud-based data processing, will be applied to store, analyze, and interpret physiological signals. These data will enable the generation of personalized health monitoring reports and corresponding clinical recommendations.

The results of this study are expected to provide essential clinical evidence supporting the development and industrialization of the non-invasive intelligent monitoring system. In addition, the study will generate key data required for device research and development, quality control standards, regulatory evaluation, and medical device registration certification, ultimately facilitating the stepwise translation of the technology into clinical practice.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult inpatients (aged ≥18 years) admitted to the cardiovascular disease ward.
  • Willing to sign the informed consent form in person.
  • Capable of understanding and following the research instructions, as well as having the language ability to communicate and fill out the relevant questionnaires.

排除标准

  • The patient has an allergic reaction to any materials related to the research equipment or test materials (such as traditional monitoring instruments, mattress fibers, etc.).
  • There are serious diseases that require urgent medical intervention, such as hypertensive emergencies, acute myocardial infarction, acute heart failure, acute stroke, severe ventricular arrhythmias, and shock, etc.
  • The patient cannot cooperate with bed rest due to their condition or mental factors.
  • Severe respiratory diseases requiring mechanical assisted ventilation.
  • Patients requiring assistance from other medical electronic devices or instruments (such as temporary cardiac pacemakers, bedside hemodialysis, etc.).
  • The research team, after assessment, considers that there are other patients who do not meet the inclusion criteria.

研究组 & 干预措施

Smart Mattress Monitoring Cohort

All enrolled participants with cardiovascular conditions are monitored using the investigational non-invasive smart mattress system. The study involves two sequential phases: Validation Phase (First 100 participants): Participants undergo simultaneous monitoring by both the investigational smart mattress and a conventional reference device (e.g., bedside ECG monitor) for algorithm calibration and performance validation. Primary Monitoring Phase (Subsequent 1000 participants): Participants are monitored solely by the calibrated smart mattress system for large-scale, continuous vital sign data collection (heart rate, respiration, temperature, posture) in a real-world clinical setting.

干预措施: Non-invasive Smart Mattress Monitoring System (Device)

结局指标

主要结局

Heart Rate and Heart Rhythm

时间窗: For three consecutive days, from 22:00 to 07:00 each day

Conventional vital signs monitoring devices or smart sensors embedded in mattresses for monitoring.

次要结局

  • Respiratory rate(For three consecutive days, from 22:00 to 07:00 each day)
  • Temperature(For three consecutive days, from 22:00 to 07:00 each day)

研究者

发起方
Beijing Anzhen Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

NingZhou

Deputy Director, Arrhythmia Center (Unit 1)

Beijing Anzhen Hospital

研究点 (1)

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