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临床试验/NCT05455775
NCT05455775已完成不适用

Video Monitoring FOR Early Signaling of Adverse EvEnts, Technical Validation

Catharina Ziekenhuis Eindhoven1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2022年8月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
Validity of the camera-based signals

研究概览

简要总结

In this study, 30 patients admitted to an high acuity department with hemodynamic or respiratory pathologies will be monitored with camera-based monitoring technologies for 24 hours. The camera's will measure heart rate and respiration rate, based on the principle of remote photoplethysmography and laser speckle vibrometry. Data will be analysed retrospectively and will be compared with vital parameters measured with the standard patient monitor.

详细描述

Rationale: In hospitals, some 40% of unanticipated deaths occur in low-acuity departments. This alarming figure reflects the limited degree to which the cardiorespiratory status of patients is monitored in these departments, due to the obtrusiveness and expense of existing monitoring technologies, as well as the unpractically high clinical workload and cost that deployment of such technologies would entail.

Objective

This project explores video monitoring of the cardiorespiratory status of the patient as an innovative unobtrusive method that could eventually aid to reduce workload for the staff and better predict (acute) deterioration or adverse cardiac events. The objective of this study is to determine the accuracy and validity of the camera-based vital parameters with respect to the measured contact sensors in intensive care unit (ICU) patients.

Study design: Observational study

Study population: Patients with cardiorespiratory pathologies on the ICU.

Main study parameters/endpoints: The primary end-point is the reliability of the video monitoring technology (remote photoplethysmography and speckle vibrometry) compared with contact sensors focusing on heart rate and respiratory rate in a clinical setting. User experience will have a continuous focus during this study.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients admitted to an high acuity unit with a planned stay of at least 4 hours
  • Patients with cardiorespiratory pathologies
  • Age >= 18

排除标准

  • Pregnant patients
  • Inability to provide written informed consent
  • Mental disability
  • Language barrier

结局指标

主要结局

Validity of the camera-based signals

时间窗: 24 hours

Validity of the video based signal compared to the measured signal obtained with a contact sensor.

Feasibility of the camera-based signals

时间窗: 24 hours

Feasibility of the video based signal compared to the measured signal obtained with a contact sensor, expressed as percentage of data loss.

次要结局

  • Insight in user and patient experience(Within 1 week after intervention)

研究者

发起方
Catharina Ziekenhuis Eindhoven
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lukas Dekker

Prof. dr. L.R.C. Dekker

Catharina Ziekenhuis Eindhoven

研究点 (1)

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