Application of Non-inductive Intelligent Physical Sign Monitoring Equipment Based on Flexible Electronic Devices in the Diagnosis and Treatment of Cardiovascular Diseases
Non-invasive Smart Mattress Monitoring System: The investigational intervention is a mattress-form monitoring device embedded with flexible sensing fibers and a multi-parameter data acquisition system. It is placed atop a standard hospital bed to unobtrusively and continuously measure vital signs including heart rate, respiratory rate, body temperature, and body posture. The device transmits data wirelessly to a secure server for real-time display, storage, and analysis via dedicated software algorithms. In the initial validation phase (first 100 participants), its measurements are synchronously compared with those from conventional bedside monitors. In the subsequent primary monitoring phase, it functions as the sole continuous monitoring tool.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria:
1. Adult inpatients (aged ≥18 years) admitted to the cardiovascular disease ward.
2. Willing to sign the informed consent form in person.
3. Capable of understanding and following the research instructions, as well as having the language ability to communicate and fill out the relevant questionnaires.
Exclusion Criteria:
1. 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.).
2. 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.
3. The patient cannot cooperate with bed rest due to their condition or mental factors.
4. Severe respiratory diseases requiring mechanical assisted ventilation.
5. Patients requiring assistance from other medical electronic devices or instruments (such as temporary cardiac pacemakers, bedside hemodialysis, etc.).
6. The research team, after assessment, considers that there are other patients who do not meet the inclusion criteria.
Primary outcome measure(s)
Heart Rate and Heart Rhythm — 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.
Trial sites (1)
Facility
City
Region
Status
Beijing Anzhen Hospital, Capital Medical University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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