Application of Non-inductive Intelligent Physical Sign Monitoring Equipment Based on Flexible Electronic Devices in the Diagnosis and Treatment of Cardiovascular Diseases
Beijing Anzhen Hospital
1,100 participants
Oct 1, 2024
OBSERVATIONAL
Conditions
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
Inclusion Criteria3
- 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.
Exclusion Criteria5
- 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.).
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07466056