HERO System - Health Monitoring for the Detection of Vital Signs and Emotional States

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-01

Study Completion Date

2025-12-31

Brief Summary

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New technologies offer significant opportunities to enhance the quality and intensity of care services, amplifying the ability to respond to patient needs through contactless solutions that also contribute to the humanization of care. Their application in patient monitoring can enable continuous observation, even in the absence of physically present staff, for a larger number of non-critical patients (thus reducing the risk of adverse events), and facilitate timely interventions when needed-aligned with the logic of Anglo-Saxon models based on Early Warning Systems.

The general objective of this study is to conduct a pilot clinical trial of a specific solution based on Artificial Intelligence and Computer Vision, the HERO Health Monitoring (HHM) system, capable of detecting vital signs (heart rate, respiratory rate, blood oxygen saturation, and blood pressure), body posture, movements, and patients' emotional states-such as expressions of pain-using simple video devices.

The study aims, in particular, to measure the concordance of the system's vital sign measurements with standard (telemetric) systems, and to assess the added value of combining these measurements with the additional information provided by HHM regarding posture, movement, and emotional state analysis-once their agreement has been verified against patient-reported outcomes collected via self-assessment questionnaires.

This is an observational study involving the HERO Health Monitoring medical device, for which the certification process is expected to be completed through the present study.

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Detailed Description

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Conditions

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Cardiovascular

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients hospitalized in the facilities of the Department of Cardiovascular Sciences

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age over 18 years
* Signed informed consent

Exclusion Criteria

* Age under 18 years
* Ongoing pregnancy
* Refusal to sign informed consent

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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TINELLI GIOVANNI

Head Endovascular Unit at Fondazione Policlinico Gemelli IRCCS in Rome; Associate Professor of Vascular Surgery at Università Cattolica del Sacro Cuore in Rome, Italy

Responsibility Role PRINCIPAL_INVESTIGATOR