RecruitingNAINTERVENTIONAL

Validation of Continuous Monitoring of Vital Signs in Children With a Connected Patch

This study is looking at a new, small device called the VT-Patch. It's designed to continuously check important body signals (vital signs) like pulse, breathing, and temperature in children in the hospital's intensive care unit. Currently, there aren't many small, wearable devices for children like there are for adults, even though they could help spot problems early after a child leaves intensive care. The main goal is to see how accurate this VT-Patch is at monitoring these vital signs in children, especially children with different skin colours. Researchers will compare its readings to the regular monitoring equipment used in the hospital to make sure it's reliable. They will also look at whether skin colour affects how well it works.

At a glance

Status

Recruiting

Phase

Sponsor

St. Justine's Hospital

Enrolment target

Start

02 Feb 2025

Estimated completion

31 Dec 2026

Vital Signs

What is this study about?

When children get better after being seriously ill, they sometimes leave the intensive care unit (PICU). Doctors are always worried that some children might need to come back to the PICU, even though it doesn't happen often. If it does, it can lead to more health problems or even be life-threatening. Right now, there aren't easy ways to keep a close eye on children's vital signs – like their heartbeat, breathing, and temperature – once they've left the intensive care unit. Small, wearable devices could help spot if a child is becoming unwell again much earlier, but similar devices for adults aren't available for children.

This study is testing a new device called the VT-Patch. It's a small, connected patch that sticks to the chest and monitors key vital signs continuously. The main purpose of this research is to check how accurately this new device works in children who are currently in the intensive care unit. The research team will watch how well it measures things like how much oxygen is in the blood, heart rate, breathing rate, and temperature. They'll compare its readings to the standard hospital monitors that are already used.

Another important aspect of this study is looking at how skin colour might affect the accuracy of the device. Some similar devices that use light (optical sensors) have not always worked as well for people with darker skin tones. This study wants to make sure the VT-Patch works for all children, no matter their skin colour. The researchers will also do some extra checks on other measures like heart rhythm (ECG), blood pressure, and movement, to see if the device can eventually monitor these too. By carefully testing this patch, the hope is to find a new, reliable way to keep children safe and help doctors react quickly if a child's health changes.

Key takeaways

Testing a new wearable device (VT-Patch) for children.
Aims to continuously monitor vital signs like heart rate and breathing.
Comparing accuracy to standard hospital monitors.
Investigating if skin colour affects device performance.
May help improve early detection of health changes in children.

Who may be eligible?

This study is looking for children aged from birth up to 18 years old. To be considered, the child must currently be staying in the intensive care unit at St. Justine's Hospital and expected to need close monitoring for at least the next 24 hours.

However, some children might not be able to join. This includes children who have recently had heart or chest surgery, or those with skin conditions or injuries on their chest that would prevent the patch from being applied safely. Also, if a parent's permission can't be obtained, or if the child's medical team thinks having a study observer in the room might interfere with their care, then the child wouldn't be able to take part.

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 in the intensive care unit at St. Justine's Hospital?
Is my child aged between 0 and 18 years old?
Is my child expected to need monitoring for at least the next 24 hours?
Does my child have any recent heart or chest surgery?
Does my child have any skin problems on their chest?
Am I willing to provide consent for my child to participate?

Answer every question to see your result.

What does participation involve?

If your child takes part, they will wear the VT-Patch on their chest for about 8 hours while they are in the intensive care unit. This patch won't replace their usual hospital monitoring equipment; it will be used alongside it. A member of the study team will be in the room occasionally to check on the device and make sure it's working properly. The researchers will compare the information from the VT-Patch with the readings from the hospital's standard monitors to see how accurate the new device is. They will also record your child's skin colour. There are no follow-up visits after your child leaves the intensive care unit for this study.

Potential risks and benefits

Taking part in this study could help future children by providing valuable information on how well this new monitoring device works, especially for children with different skin colours. This could lead to better tools for spotting early signs of illness in children. The main risk would be possible mild skin irritation from the patch, but this is usually minor and temporary. Other risks are very low as the device is for monitoring only and won't affect your child's medical treatment. You have the right to withdraw your child from the study at any time, for any reason, without it affecting their medical care.

Locations (1)

CHU Sainte Justin Hospital
Verified postcode
Montreal, Canada· Recruiting

Common questions

What is the VT-Patch?

It's a small, wearable device that sticks to the skin to continuously monitor vital signs like heart rate and breathing in children.

Why is this study important for children?

It helps test new technology that could make it easier to monitor children's health, helping doctors respond quickly if they become unwell after leaving intensive care.

Will the VT-Patch replace my child's current hospital monitors?

No, the VT-Patch will be used in addition to, not instead of, your child's usual hospital monitoring equipment.

Will this study affect my child's medical treatment?

No, taking part in this study will not affect your child's medical treatment in any way.

What if my child has sensitive skin?

Skin conditions or lesions on the chest might prevent your child from participating to ensure the patch is applied safely.

How to find out more

Philippe Jouvet, MD, PhD

philippe.jouvet@umontreal.ca 514-345-4931 Official trial record

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