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临床试验/NCT05202769
NCT05202769招募中不适用

Non-Invasive Vital Signs Monitoring (NIVS) Project

Sciberras, Stephen M.D.1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年2月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
Respiratory rate as measured by a camera system

研究概览

简要总结

This study is aimed at non-invasive extraction of cardiovascular and respiratory parameters from red-green-blue (RGB) and thermal imaging cameras from patients in the intensive care unit (ICU) setting. The main focus of this study is in assessing the feasibility of implementing such a camera-based system for prolonged monitoring of patients, identifying limiting factors which may interfere with accuracy or practical aspects of the system, and postulating solutions to overcoming these.

详细描述

Non-invasive monitoring of vital signs is an area that is gaining increasing popularity in clinical practise due to its advantages of increased comfort to patients and reduced risk of transmission of multidrug resistant organisms. This study aims to assess the feasibility of using RGB cameras and thermal imaging cameras for monitoring of heart rate and rhythm and respiratory rate and rhythm in the intensive care setting.

Videos of patients are taken in the ICU of a Maltese University-affiliated tertiary hospital (Mater Dei Hospital) under varying conditions, including varying light intensity, different patient positions and periods of time where clinical staff are performing regular care tasks and minor interventions such as bloodletting. Patients enrolled will be able to provide consent for the study after being given a detailed explanation of the study aims, data collected, data storage and processing and any other information they may wish to know.

The video data will be analysed via a convolutional neural network which has been previously trained to extract cardiovascular and respiratory parameters from videos taken from healthy volunteers in a non-clinical setting (a laboratory located in the University of Malta). The heart rate and respiratory rate extracted from patient videos are then compared to ground truth data obtained by current gold standard contact monitoring (data collected from Phillips Intellivue monitors used throughout the ICU) and assessed for accuracy. The practicality of setting up a camera-based system in the intensive care setting and potential means of overcoming limitations faced will also be tackled in this study from a qualitative aspect.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age above 18 years and able to provide consent

排除标准

  • age under 18 years and known cardiovascular or respiratory diseases

结局指标

主要结局

Respiratory rate as measured by a camera system

时间窗: 1 day

Heart Rate, as measured by a camera system

时间窗: 1 day

次要结局

  • To assess the accuracy of parameters obtained via the camera-based system as compared to the traditional contact monitoring system.(1 day)

研究者

发起方
Sciberras, Stephen M.D.
申办方类型
Indiv
责任方
Principal Investigator
主要研究者

Stephen Sciberras

Primary Investigator

Sciberras, Stephen M.D.

研究点 (1)

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