Multimometer - Vital Signs Device for Diagnosis of Pneumonia
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
- 是
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
Israel Amirav
MD
University of Alberta
