Pneumonia Clinical Trial
Official title:
Multimometer - Vital Signs Device for Diagnosis of Pneumonia
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.
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.
C. Compare vital signs measurements by Multimometer® to simultaneous vital signs measurement
using conventional devices.
For this part of the study, repeated (x5 times) measurements of the 4 vital signs in 50 young
children (under 5 yrs) in hospital/clinics in Butembo DRC with suspected pneumonia, will be
recorded using the Multimometer. These signs will also be measured at the same time, by
conventional methods (regular thermometers for temperature, observed respiratory rate using
recorded chest movements and end-tidal carbon dioxide (CO2) for respiratory rate, standard
pulse oximeters for oxygen saturation and heart rate). All these measurements take less than
5 minutes. The investigators will repeat these sets approximately 5 times during the same day
in the hospital or during a clinic visit. The vital signs will be compared between the two
methods using Pearson's correlation coefficient and using Bland-Altman plots for agreement.
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