PneumoniaNCT03265756
Multimometer - Vital Signs Device for Diagnosis of Pneumonia
An observational study of Pneumonia, run by University of Alberta at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumonia
- What is being tested?
- Multimometer
- Type of treatment
- Medical device
- How many people
- 350 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 20 Jun 2017to 30 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children under 5y of age
Who may be able to join
- 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
Who cannot join
- Children older than 5y of age
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Democratic Republic of the Congo1 site
AHFIA (Association for Health Innovation in Africa)
Butembo, North Kivu
About this study
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.
Read the detailed description
- 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.
- 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.
- 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.
- Conditions
- Pneumonia
- Being tested
- Multimometer
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MultimometerDevice
A device for measuring respiration rate, temperature, heart rate and the degree of blood oxygenation of children
| Study group | Role | What they receive |
|---|---|---|
| Healthy children | 250 3D facial images of healthy children under 5yrs of age in the Democratic Republic of Congo (DRC). | |
| Suspected Pneumonia | 50 young children (under 5 yrs) in hospital/clinics in Butembo DRC with suspected pneumonia Receives: Device: Multimometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vital Signs Comparison
Measurements of respiration rate, temperature, heart rate and the degree of blood oxygenation of children
Measured: 2018
Secondary outcomes (1)
3D facial images
Measurements of facial dimensions and contour
Measured: 2017-2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start20 Jun 2017
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Grand Challenges Canada
- Responsible party
- Principal investigator, Israel Amirav, University of Alberta
- Investigators
- Israel Amirav, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03265756
- Sponsor's protocol ID
- Pro00072555
- Status last verified
- Nov 2018
- First submitted
- 26 Aug 2017
- Last updated
- 21 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimometer - Vital Signs Device for Diagnosis of Pneumonia
- ClinicalTrials.gov ID
- NCT03265756
- Acronym / sponsor ID
- Pro00072555
- Conditions
- Pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Grand Challenges Canada
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 29 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy children | – | –250 3D facial images of healthy children under 5yrs of age in the Democratic Republic of Congo (DRC). |
| Suspected Pneumonia | – | Device: Multimometer50 young children (under 5 yrs) in hospital/clinics in Butembo DRC with suspected pneumonia |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children under 5y of age
Key inclusion criteria (4 listed)
- Healthy children under 5y of age
- Children under 5y of age with suspected pneumonia
Key exclusion criteria (1 listed)
- Children older than 5y of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MultimometerA device for measuring respiration rate, temperature, heart rate and the degree of blood oxygenation of children | Device | Suspected Pneumonia |
Primary outcome
Vital Signs Comparison
Time frame: 2018
Measurements of respiration rate, temperature, heart rate and the degree of blood oxygenation of children
1 secondary outcome
3D facial images
Time frame: 2017-2018
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Israel Amirav principal investigator
University of Alberta
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia, run by University of Alberta at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada, Democratic Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vital Signs Comparison (time frame: 2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2018.