Vital SignsVITALPICUNCT04627766
Validation of Continuous Monitoring of Vital Signs in Children With a Connected Patch
A study testing Monitoring with VT-Patch (Connected device manufactured by VitalTracer) in people with Vital Signs, run by St. Justine's Hospital at 1 site in Canada.
Trial summary
Small connected devices monitoring vital signs do not exist in children although they could be very useful to monitor patients once they have left the pediatric intensive care unit (PICU) in order to early identify patients at risk of PICU readmission. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Vital Signs
- What is being tested?
- Monitoring with VT-Patch (Connected device manufactured by VitalTracer)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- 2 Feb 2025to 31 Dec 2026
- Phase
- Interventional
- 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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children (0 to 18 years old) admitted in St. Justine's Hospital's PICU.
- 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 is 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
About this study
Official title: Validation of Continuous Monitoring of Vital Signs in Children With VTPatch Connected Device in the Pediatric Intensive Care Unit
Small connected devices monitoring vital signs do not exist in children although they could be very useful to monitor patients once they have left the pediatric intensive care unit (PICU) in order to early identify patients at risk of PICU readmission.
The main objective of this study is to assess the accuracy of a connected thoracic patch (VT-Patch) for the continuous monitoring of vital signs in PICU patients.
Read more
This monitoring device will be used to monitor children in PICU for 8 hours and results will be compared to the standard of care in the unit which is the Philips monitoring system.
The investigators will assess the device's accuracy for the monitoring of 4 vital signs (SpO2, heart rate, respiratory rate and temperature) and perform exploratory assessment of three additional parameters (EKG, blood pressure and movement capture). The skin colour of each participant will be categorized based on Fitzpatrick scale and non-invasive spectroscopic method.
Read the detailed description
Introduction:
Patients readmission to PICU is a major point of concern for physician because, although being a rare event, it has been strongly associated to more morbidity and death. Patients 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 monitoring of 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.
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 monitoring for 3 additional physiologic parameters (heart rate (HR), respiratory rate (RR) and temperature). Exploratory assessment of blood pressure (BP) monitoring, ECG signal and movement capture. The effect of the skin colour on the vital signs measurements will be investigated as well.
Design:
Prospective validation study of VT-Patch device for the monitoring 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 the device on 5 children to assess the feasibility of the protocol.
- Main study: validation phase of the device on 2 children per age group per skin phototype (based on Monk scale) to assess its accuracy. The patients of the run-in phase will be included in the main study if no modification of the protocol is required. 4 physiologic parameters (HR, SpO2, RR, temperature and BP) and ECG will be prospectively recorded during 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.
Participating center: 1 center (St. Justine's Hospital).
Perspectives: This validation step of the collected data is necessary to validate that VT-Patch is suitable for pediatric patient monitoring of all skin colors.
- Conditions
- Vital Signs
- Being tested
- Monitoring with VT-Patch (Connected device manufactured by VitalTracer)
- Keywords
- Pediatrics, All-in-One, Wireless, Pateint remote monitoring, SpO2, Pulse oximeter, Skin Colour, VT-Patch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring with VT-Patch (Connected device manufactured by VitalTracer)Device
Patients will be monitored for 8 consecutive hours and vital signs will be recorded with VT-Patch and with the standard of care
| Study group | Role | What they receive |
|---|---|---|
| Monitored children | Experimental | PICU Children that will be monitored with the device Receives: Device: Monitoring with VT-Patch (Connected device manufactured by VitalTracer) |
What is being measured
The primary outcome is the main question the study is designed to answer.
SpO2
Percentage of the difference between the absolute value of SpO2 recorded by VT-Patch and the one recorded using standard of care
Measured: 8 hours
Secondary outcomes (3)
Heart rate
Percentage of the difference between the absolute value of heart rate recorded by VT-Patch and the one recorded using the standard of care
Measured: 8 hours
Respiratory rate
Percentage of the difference between the absolute value of respiratory rate recorded by VT-Patch and the one recorded using standard of care
Measured: 8 hours
Temperature
Percentage of the difference between the absolute value of temperature recorded by VT-Patch and the one recorded using standard of care
Measured: 8hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start2 Feb 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion31 Dec 2026 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Monitoring of vital signs with VT-Patch and standard of care
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philippe Jouvet, St. Justine's Hospital
- Investigators
- Philippe Jouvet, MD, PhD, Principal investigator, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04627766
- Sponsor's protocol ID
- 2021-3157
- Acronym
- VITALPICU
- Status last verified
- Dec 2025
- First submitted
- 9 Nov 2020
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Continuous Monitoring of Vital Signs in Children With VTPatch Connected Device in the Pediatric Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04627766
- Acronym / sponsor ID
- VITALPICU / 2021-3157
- Conditions
- Vital Signs
- Keywords
- Pediatrics, All-in-One, Wireless, Pateint remote monitoring, SpO2, Pulse oximeter, Skin Colour, VT-Patch
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- 2 Feb 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Nov 2020 (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.
Small connected devices monitoring vital signs do not exist in children although they could be very useful to monitor patients once they have left the pediatric intensive care unit (PICU) in order to early identify patients at risk of PICU readmission.
The main objective of this study is to assess the accuracy of a connected thoracic patch (VT-Patch) for the continuous monitoring of vital signs in PICU patients.
This monitoring device will be used to monitor children in PICU for 8 hours and results will be compared to the standard of care in the unit which is the Philips monitoring system.
The investigators will assess the device's accuracy for the monitoring of 4 vital signs (SpO2, heart rate, respiratory rate and temperature) and perform exploratory assessment of three additional parameters (EKG, blood pressure and movement capture). The skin colour of each participant will be categorized based on Fitzpatrick scale and non-invasive spectroscopic method.
Detailed description
Introduction:
Patients readmission to PICU is a major point of concern for physician because, although being a rare event, it has been strongly associated to more morbidity and death. Patients 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 monitoring of 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.
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 monitoring for 3 additional physiologic parameters (heart rate (HR), respiratory rate (RR) and temperature). Exploratory assessment of blood pressure (BP) monitoring, ECG signal and movement capture. The effect of the skin colour on the vital signs measurements will be investigated as well.
Design:
Prospective validation study of VT-Patch device for the monitoring 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 the device on 5 children to assess the feasibility of the protocol.
- Main study: validation phase of the device on 2 children per age group per skin phototype (based on Monk scale) to assess its accuracy. The patients of the run-in phase will be included in the main study if no modification of the protocol is required. 4 physiologic parameters (HR, SpO2, RR, temperature and BP) and ECG will be prospectively recorded during 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.
Participating center: 1 center (St. Justine's Hospital).
Perspectives: This validation step of the collected data is necessary to validate that VT-Patch is suitable for pediatric patient monitoring of all skin colors.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Monitoring of vital signs with VT-Patch and standard of care
| Arm | Type | Receives |
|---|---|---|
| Monitored children | Experimental | Device: Monitoring with VT-Patch (Connected device manufactured by VitalTracer)PICU Children that will be monitored with the device |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children (0 to 18 years old) admitted in St. Justine's Hospital's PICU.
- 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 is 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 |
|---|---|---|
| Monitoring with VT-Patch (Connected device manufactured by VitalTracer)Patients will be monitored for 8 consecutive hours and vital signs will be recorded with VT-Patch and with the standard of care | Device | Monitored children |
Primary outcome
SpO2
Time frame: 8 hours
Percentage of the difference between the absolute value of SpO2 recorded by VT-Patch and the one recorded using standard of care
3 secondary outcomes
Heart rate
Time frame: 8 hours
Respiratory rate
Time frame: 8 hours
Temperature
Time frame: 8hours
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 18 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Philippe Jouvet, MD, PhD principal investigator
St. Justine's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monitoring with VT-Patch (Connected device manufactured by VitalTracer) in people with Vital Signs, run by St. Justine's Hospital 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 2 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 18 Dec 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 Philippe Jouvet, MD, PhD (514-345-4931 ext. 5549, philippe.jouvet@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SpO2 (time frame: 8 hours). 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 18 Dec 2025.