RecruitingOBSERVATIONAL

Validation of Vital Signs Recording With VT-Patch Connected Devices in Children

This study is looking at a new, small device called VT-Patch that can record important health information, such as oxygen levels, heart rate, and breathing, for children. Currently, adult versions of these devices exist, but not many for children. The aim is to see how accurate this device is when monitoring children, especially those who have been in intensive care. Researchers are particularly interested in making sure it works correctly for children with all skin colours, as some skin tones can affect how well these types of devices read information. If successful, this device could help doctors spot problems early after a child leaves intensive care.

At a glance

Status

Recruiting

Sponsor

VitalTracer Ltd.

Enrolment target

Start

03 Feb 2025

Estimated completion

31 Dec 2025

Vital Signs Oxygen Saturation Children Intensive Care Unit Heart Rate Respiratory Rate

What is this study about?

Doctors are always looking for better ways to keep an eye on children, especially after they've been very ill in an intensive care unit (ICU). While in the ICU, children are closely watched. However, when they leave, the way their health is monitored often changes. Sometimes, problems can pop up after leaving the ICU, and doctors want to find ways to spot these issues early.

This study is about a new, small device called VT-Patch. It's designed to stick to the skin and record important health information like oxygen levels in the blood, heart rate, and breathing. These are called 'vital signs'. The main goal is to check how accurate this VT-Patch device is when used on children.

One very important part of this study is making sure the device works well for everyone. Previous research has found that some devices that use light to measure things, like oxygen levels, might not work as accurately on people with darker skin. This study wants to confirm that the VT-Patch works just as well for children with all different skin colours. If it does, it could be a really helpful tool to keep children safer and healthier after they leave intensive care.

Key takeaways

A new device, VT-Patch, is being tested to monitor children's vital signs.
The study aims to ensure the device works accurately for all skin colours.
It could help doctors spot problems early in children after intensive care.
Your child will wear the device for about 8 hours.
The data collected will not directly affect your child's treatment during the study.

Who may be eligible?

To be able to join this study, a child must be currently staying in the hospital's intensive care unit (PICU) and expected to stay there for at least the next 24 hours.

However, some children won't be able to take part. This includes children who have recently had heart or chest surgery, or those who have a rash or skin problem on their chest where the patch would need to go. Also, if a parent or guardian doesn't give permission, the child cannot join.

Finally, if the doctor or nurse looking after the child thinks that having an observer in the room for parts of the study would be upsetting or not good for the child's health, then the child would not be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is my child currently in the Intensive Care Unit (PICU)?
Is my child expected to stay in the PICU for at least the next 24 hours?
Has my child NOT had any recent heart or chest surgery?
Does my child NOT have any skin problems on their chest where a patch would go?
Am I, as the parent/guardian, willing to give my permission for my child to take part?

Answer every question to see your result.

What does participation involve?

If a child takes part in this study, the VT-Patch device will be gently attached to their skin. It will stay on for about 8 hours. During this time, the device will record important information like heart rate, oxygen levels, breathing rate, and temperature. This information will be collected at the same time as the hospital's usual monitoring equipment. A trained team member will be there to make sure everything is working correctly.

It's important to know that the information gathered by the VT-Patch device in the study will *not* be used by the doctors or nurses to make treatment decisions for your child. They will continue to rely on the hospital's standard monitoring systems for your child's care. The study will also look at other things like blood pressure (BP), heart's electrical activity (ECG), and movement patterns, but these are more for exploring how the device works.

The study has two main parts: a small 'run-in' phase with a few children to check the process, followed by the main study. In total, up to 12 children in different age groups will be included, making sure there are children with various skin colours. The overall time your child would be involved is for a single 8-hour recording session.

Potential risks and benefits

There is no direct medical benefit to your child from taking part in this study, as the device is being tested and won't guide their immediate care. However, the information gathered could help future children by leading to better ways of monitoring them after intensive care. The risks are very low; the patch is non-invasive, meaning it doesn't go inside the body. There might be a slight skin irritation from the patch adhesive, similar to a plaster. You have the right to withdraw your child from the study at any time without giving a reason, and this will not affect your child's care in any way.

Locations (1)

CHU Sainte Justin Hospital
Verified postcode
Montreal, Canada· Recruiting

Common questions

What is the VT-Patch?

It's a small, sticky device that goes on the skin to measure vital signs like heart rate, oxygen, and breathing.

Why is this study important for children with different skin colours?

Some devices like this might not work as well on darker skin, so this study wants to make sure the VT-Patch is accurate for all children, no matter their skin colour.

Will the VT-Patch change my child's medical treatment?

No, the information from the VT-Patch in this study won't be used for your child's direct care. Doctors will still use the hospital's usual monitors for treatment decisions.

How long will my child wear the VT-Patch?

Your child will wear the patch for about 8 hours during the study.

What happens if I change my mind about my child participating?

You can withdraw your child from the study at any time, and it won't affect their medical care.

How to find out more

Azadeh Dastmalchi, PhD

azadeh.dastmalchi@vitaltracer.com +1(613)2761413 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.