跳至主要内容
临床试验/NCT07248969
NCT07248969进行中(未招募)不适用

Observational Pilot Study on the Use of the HERO Health Monitoring System for the Detection of Vital Signs, Emotional States, and Body Postures

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
100
试验地点
1
主要终点
Level of agreement between heart rate (measured as beats per minute) collected via HHM (Home Health Monitoring) system and those obtained from standard telemetry monitoring, measured using Intraclass Correlation Coefficient

研究概览

简要总结

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.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Level of agreement between heart rate (measured as beats per minute) collected via HHM (Home Health Monitoring) system and those obtained from standard telemetry monitoring, measured using Intraclass Correlation Coefficient

时间窗: 6 months

This measure evaluates the level of concordance between heart rate (measured as beats per minute) collected by the HHM (Home Health Monitoring) system and those obtained from standard clinical telemetric monitoring systems. The agreement will be assessed using statistical methods such as Bland-Altman analysis, Intraclass Correlation Coefficient (ICC), and/or paired t-tests depending on the distribution and type of data. Measurements will be reported as mean values with standard deviations, and limits of agreement where appropriate.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (1)

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