跳至主要内容
临床试验/NCT05451875
NCT05451875招募中不适用

Validation of Vital Signs Recording with VT-Patch® Connected Devices in Children

VitalTracer Ltd.1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2025年2月3日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
48
试验地点
1
主要终点
Accuracy of VitalTracer devices Oxygen Saturation (SPO2) measurement for different skin colour

研究概览

简要总结

: Patient readmission to PICU is a major point of concern for physicians because, although being a rare event, it has been strongly associated with more morbidity and death. Patient monitoring once they have left the PICU is drastically modified, and small connected devices could be an option to early identify patients at risk of PICU readmission. Such devices have been manufactured for the recording of vital signs in adults, but they do not exist for children.

Besides, studies have recently shown that devices that use optical sensors may be less accurate in individuals with dark skin pigmentation since dark skin tones impose a limitation on optical biometric sensing. The wearable and medical device industry has not sufficiently addressed this issue yet. This is one of the main challenges that need to be addressed in this area to make sure the connected devices using this technology will work with all different skin colours including very dark skin.

详细描述

Main objective: Assess the accuracy of VT-Patch® to measure oxygen saturation (SpO2) in children with diverse skin colour.

Secondary objectives: Assess the accuracy of VT-Patch® to measure 3 additional physiologic parameters (heart rate (HR), respiratory rate (RR), and temperature. Exploratory assessment of blood pressure (BP) measurement, ECG signal, and movement capture.

Design: Prospective validation study of VT-Patch® for the recording of 4 physiologic parameters and exploratory assessment of three additional parameters.

Methods: The study will be performed in two successive phases:

Run-in phase: Testing VT-Patch® on four children to assess the feasibility of the protocol.

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
1 Day 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • PICU monitoring for the next 24 hours

排除标准

  • Recent cardiac or thoracic surgery
  • Thoracic skin lesion that contraindicates the VT patch
  • No parental consent
  • Intermittent presence of one study observer in the patient room considered inappropriate by the physician or the nurse in charge because of the child's medical condition

结局指标

主要结局

Accuracy of VitalTracer devices Oxygen Saturation (SPO2) measurement for different skin colour

时间窗: 8 hours per subject

Percentage of the difference between the absolute value of SpO2 recorded by VT-Patch and the one recorded in high resolution database.

次要结局

  • Accuracy of VitalTracer devices blood pressure, heart rate, skin temperature, and Electrocardiogram (ECG) measurement(8 hours per subject)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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