Ignite Creation Date:
2024-05-06 @ 10:27 AM
Last Modification Date:
2024-10-26 @ 12:30 PM
Study NCT ID:
NCT03265756
Status:
COMPLETED
Last Update Posted:
2018-11-21
First Post:
2017-08-26
Brief Title:
Multimometer - Vital Signs Device for Diagnosis of Pneumonia
Sponsor:
University of Alberta
Organization:
University of Alberta
Study Overview
Official Title:
Multimometer - Vital Signs Device for Diagnosis of Pneumonia
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 childrens 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
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 childrens 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
Detailed Description:
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 hospitalclinic the investigators will use a three-dimension 3D special camera to obtain an image of the childs 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 hospitalclinics 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 Pearsons correlation coefficient and using Bland-Altman plots for agreement
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 hospitalclinic the investigators will use a three-dimension 3D special camera to obtain an image of the childs 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 hospitalclinics 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 Pearsons correlation coefficient and using Bland-Altman plots for agreement
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None