Vital SignsVTNCT05451875
Validation of Vital Signs Recording With VT-Patch Connected Devices in Children
An observational study of Vital Signs and Oxygen Saturation, run by VitalTracer Ltd. at 1 site in Canada.
Trial summary
: Patient readmission to PICU is a major point of concern for physicians because, although being a rare event, it has been strongly associated with more morbidity and death. Patient monitoring once they have left the PICU is drastically modified, and small connected devices could be an option to early identify… Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Vital Signs, Oxygen Saturation, Children
- What is being tested?
- Non-invasive monitoring
- Type of treatment
- Medical device
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- 3 Feb 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: In order to achieve at least 80% match between physiological data's recorded with VT-Patch®, or VT-Watch® and with the standard of care (tolerated difference: 2% for SpO2), this study will include 10 patients per age group (see below) including 4 patients per age group with invasive arterial pressure monitoring (arterial line). 1. Neonates: 0 - 28 days 2. Infants:29 days - 2 years 3. Children: 2 - 12 years 4. Adolescents:12 - 18 years
Who may be able to join
- PICU monitoring for the next 24 hours
Who cannot join
- Recent cardiac or thoracic surgery
- Thoracic skin lesion that contraindicates the VT patch
- No parental consent
- Intermittent presence of one study observer in the patient room considered inappropriate by the physician or the nurse in charge because of the child's medical condition
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
CHU Sainte Justin Hospital
Montreal, Quebec, H3T 1C5
Philippe Jouvet, MD, PhD, (514) 345-4931, philippe.jouvet.med@ssss.gouv.qc.ca
Azadeh Dastmalchi, PhD, +1(613)2761413, azadeh.datmalchi@vitaltracer.com
About this study
Official title: Validation of Vital Signs Recording With VT-Patch® Connected Devices in Children
: Patient readmission to PICU is a major point of concern for physicians because, although being a rare event, it has been strongly associated with more morbidity and death. Patient monitoring once they have left the PICU is drastically modified, and small connected devices could be an option to early identify patients at risk of PICU readmission. Such devices have been manufactured for the recording of vital signs in adults, but they do not exist for children.
Besides, studies have recently shown that devices that use optical sensors may be less accurate in individuals with dark skin pigmentation since dark skin tones impose a limitation on optical biometric sensing. The wearable and medical device industry has not sufficiently addressed this issue yet. This is one of the main challenges that need to be addressed in this area to make sure the connected devices using this technology will work with all different skin colours including very dark skin.
Read the detailed description
Main objective: Assess the accuracy of VT-Patch® to measure oxygen saturation (SpO2) in children with diverse skin colour.
Secondary objectives: Assess the accuracy of VT-Patch® to measure 3 additional physiologic parameters (heart rate (HR), respiratory rate (RR), and temperature. Exploratory assessment of blood pressure (BP) measurement, ECG signal, and movement capture.
Design: Prospective validation study of VT-Patch® for the recording of 4 physiologic parameters and exploratory assessment of three additional parameters.
Methods: The study will be performed in two successive phases:
Run-in phase: Testing VT-Patch® on four children to assess the feasibility of the protocol.
Main study: validation phase of the devices on 12 children per age group (2 children per skin colour group) to assess its accuracy (VT-Patch® for less than 2 years old). The patients of the run-in phase will be included in the main study if no modification of the protocol is required. 5 physiologic parameters (HR, SpO2, RR, temperature, and ECG) will be prospectively and simultaneously recorded for 8 hours with VT-Patch® and the regular monitoring system implemented in the unit High-resolution database that will be the gold standard for evaluation. Vital signs recorded with the connected device will not be used for the clinical care of patients. The Skin colour of each patient will be assessed by the colorimetric Monk scale and as shown below.
- Conditions
- Vital Signs, Oxygen Saturation, Children, Intensive Care Unit, Heart Rate, Respiratory Rate
- Being tested
- Non-invasive monitoring
- Keywords
- Vital signs, SPO2, ECG, Continuous, Skin temperature, Heart rate, VitalTracer, Wearable, All-in-one, Children, PICU, Different Skin Color, Dark skin color, Monk Scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive monitoringDevice
Comparison of VitalTracer monitoring devices with invasive and/or non-invasive gold standard reference
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of VitalTracer devices Oxygen Saturation (SPO2) measurement for different skin colour
Percentage of the difference between the absolute value of SpO2 recorded by VT-Patch and the one recorded in high resolution database.
Measured: 8 hours per subject
Secondary outcomes (1)
Accuracy of VitalTracer devices blood pressure, heart rate, skin temperature, and Electrocardiogram (ECG) measurement
Percentage of the difference between the absolute value of Blood Pressure, Heart Rate and skin temperature and the quality of ECG signals recorded by the VT-Patch and the one recorded in high resolution database.
Measured: 8 hours per subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start3 Feb 2025
- Primary completion1 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vital SignsStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VitalTracer Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- St. Justine's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05451875
- Sponsor's protocol ID
- VT001
- Acronym
- VT
- Status last verified
- Mar 2025
- First submitted
- 27 Jun 2022
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Vital Signs Recording With VT-Patch® Connected Devices in Children
- ClinicalTrials.gov ID
- NCT05451875
- Acronym / sponsor ID
- VT / VT001
- Conditions
- Vital Signs, Oxygen Saturation, Children, Intensive Care Unit, Heart Rate, Respiratory Rate
- Keywords
- Vital signs, SPO2, ECG, Continuous, Skin temperature, Heart rate, VitalTracer, Wearable
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- VitalTracer Ltd.Industry (pharma, biotech, devices)
- Collaborators
- St. Justine's Hospital
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 11 Jul 2022 (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.
: Patient readmission to PICU is a major point of concern for physicians because, although being a rare event, it has been strongly associated with more morbidity and death. Patient monitoring once they have left the PICU is drastically modified, and small connected devices could be an option to early identify patients at risk of PICU readmission. Such devices have been manufactured for the recording of vital signs in adults, but they do not exist for children.
Besides, studies have recently shown that devices that use optical sensors may be less accurate in individuals with dark skin pigmentation since dark skin tones impose a limitation on optical biometric sensing. The wearable and medical device industry has not sufficiently addressed this issue yet. This is one of the main challenges that need to be addressed in this area to make sure the connected devices using this technology will work with all different skin colours including very dark skin.
Detailed description
Main objective: Assess the accuracy of VT-Patch® to measure oxygen saturation (SpO2) in children with diverse skin colour.
Secondary objectives: Assess the accuracy of VT-Patch® to measure 3 additional physiologic parameters (heart rate (HR), respiratory rate (RR), and temperature. Exploratory assessment of blood pressure (BP) measurement, ECG signal, and movement capture.
Design: Prospective validation study of VT-Patch® for the recording of 4 physiologic parameters and exploratory assessment of three additional parameters.
Methods: The study will be performed in two successive phases:
Run-in phase: Testing VT-Patch® on four children to assess the feasibility of the protocol.
Main study: validation phase of the devices on 12 children per age group (2 children per skin colour group) to assess its accuracy (VT-Patch® for less than 2 years old). The patients of the run-in phase will be included in the main study if no modification of the protocol is required. 5 physiologic parameters (HR, SpO2, RR, temperature, and ECG) will be prospectively and simultaneously recorded for 8 hours with VT-Patch® and the regular monitoring system implemented in the unit High-resolution database that will be the gold standard for evaluation. Vital signs recorded with the connected device will not be used for the clinical care of patients. The Skin colour of each patient will be assessed by the colorimetric Monk scale and as shown below.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- In order to achieve at least 80% match between physiological data's recorded with VT-Patch®, or VT-Watch® and with the standard of care (tolerated difference: 2% for SpO2), this study will include 10 patients per age group (see below) including 4 patients per age group with invasive arterial pressure monitoring (arterial line). 1. Neonates: 0 - 28 days 2. Infants:29 days - 2 years 3. Children: 2 - 12 years 4. Adolescents:12 - 18 years
Key inclusion criteria (1 listed)
- PICU monitoring for the next 24 hours
Key exclusion criteria (4 listed)
- Recent cardiac or thoracic surgery
- Thoracic skin lesion that contraindicates the VT patch
- No parental consent
- Intermittent presence of one study observer in the patient room considered inappropriate by the physician or the nurse in charge because of the child's medical condition
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 |
|---|---|---|
| Non-invasive monitoringComparison of VitalTracer monitoring devices with invasive and/or non-invasive gold standard reference | Device | – |
Primary outcome
Accuracy of VitalTracer devices Oxygen Saturation (SPO2) measurement for different skin colour
Time frame: 8 hours per subject
Percentage of the difference between the absolute value of SpO2 recorded by VT-Patch and the one recorded in high resolution database.
1 secondary outcome
Accuracy of VitalTracer devices blood pressure, heart rate, skin temperature, and Electrocardiogram (ECG) measurement
Time frame: 8 hours per subject
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vital Signs and Oxygen Saturation, run by VitalTracer Ltd. at 1 site in Canada.
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 1 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Azadeh Dastmalchi, PhD (+1(613)2761413, azadeh.dastmalchi@vitaltracer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of VitalTracer devices Oxygen Saturation (SPO2) measurement for different skin colour (time frame: 8 hours per subject). 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 10 Mar 2025.