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临床试验/NCT03265756
NCT03265756已完成不适用

Multimometer - Vital Signs Device for Diagnosis of Pneumonia

University of Alberta2 个研究点 分布在 2 个国家目标入组 350 人开始时间: 2017年6月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
350
试验地点
2
主要终点
Vital Signs Comparison

研究概览

简要总结

Pneumonia is a major cause of illness in young children. The investigators are developing and testing a new thermometer like device called Multimometer, to measure the respiration rate (RR), temperature, heart rate (HR) and the degree of blood oxygenation (SpO2) of children who may suffer from pneumonia. These are called vital signs and their measurements greatly help to diagnose pneumonia.

In the first part of the study, and in order to optimize and better align the size of the device with the face, the investigators will measure the average size and dimensions of young children's face. In the second part of the study, the investigators will compare the vital signs measurements with measurements obtained by other commonly used devices in ill children who are suspected to suffer from pneumonia.

详细描述

A. Improve the universality of the mouth-interface using facial anthropometry techniques.

For this first part of the study, the investigators will use a portable 3D camera (as previously used by our group) to acquire 250 3D facial images of healthy children under 5yrs of age in the DRC. While in hospital/clinic, the investigators will use a three-dimension (3D) special camera to obtain an image of the child's face. The child can sit on the lap of the parent and we will take the image. The image acquisition takes less than 30 seconds. There are no specific requirements from the child, and the image can be taken if the child is asleep or awake, cry or settled. No medical or identifying information will be collected.

All the computerized images will be cluster analyzed (using previously established methodologies from the Technion, Israel) and three 3D average faces of all small, medium and large faces will be constructed. The investigators will use these "faces" to design better Multimometers with improved mouth-interface for this population.

B. Integrate into the current device a reflexive pulse oximeter sensor which will allow measurements of oxygen saturation and heart rate.

For the addition of HR and SpO2 measurements, the investigators will integrate a reflective pulse oximetry chip into the probe. Together with the manufacturer (RespiDx Inc., Israel) the investigators will design and manufacture optimal prototype devices suitable for performing clinical trials on this population.

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
— 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • For the first part of the study (3D facial images):
  • Healthy children under 5y of age
  • For the second phase of the study (Comparison of vital signs):
  • Children under 5y of age with suspected pneumonia

排除标准

  • Children older than 5y of age

结局指标

主要结局

Vital Signs Comparison

时间窗: 2018

Measurements of respiration rate, temperature, heart rate and the degree of blood oxygenation of children

次要结局

  • 3D facial images(2017-2018)

研究者

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

Israel Amirav

MD

University of Alberta

研究点 (2)

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