RecruitingNAINTERVENTIONAL

Custom Non-invasive Ventilation Masks in Children

This study is testing custom-made breathing masks for children who use a special machine called non-invasive ventilation (NIV) to help them breathe. Many children struggle with standard masks because they don't fit well, especially if they have unique facial shapes. A poor fit can be uncomfortable and make the breathing treatment less effective. This research aims to create masks specifically tailored to each child's face using 3D scanning technology. We want to see if these custom masks are more comfortable, fit better, and help children use their breathing machines more consistently than the usual masks. The study will compare custom masks with current masks to find out which one works best for children and their families.

At a glance

Status

Recruiting

Phase

Sponsor

University of Alberta

Enrolment target

Start

15 Dec 2023

Estimated completion

01 Jun 2026

Noninvasive Ventilation Child, Only Adherence, Patient

What is this study about?

When children need help with their breathing using a machine called non-invasive ventilation (NIV), finding a mask that fits just right can be a big problem. Children's faces grow and change, and they often have different shapes compared to adults. Current masks, even those made for children, don't always fit well. A mask that doesn't fit properly can be uncomfortable, let air leak out, and make the breathing support less helpful. For some children, this can even mean needing a breathing tube surgically placed in their neck, which is something we'd like to avoid if possible.

This study is exploring a really exciting new idea: making custom breathing masks that are perfectly shaped to each child's face. We'll use a special 3D scanner (like a fancy camera) to create a detailed picture of a child's face. This picture then helps us design and 3D print a mask that's unique to them. We want to see if these custom masks are more comfortable and work better than the standard masks currently available.

To do this, we'll ask children who already use a breathing machine at home but struggle with their current mask to take part. We'll compare how well their usual mask works against a new custom-made one. We'll check things like how much air leaks out, how comfortable the mask is, and if children use their breathing machine more often with the new mask. We'll also ask children and their parents which mask they prefer and why, as their comfort and happiness are really important.

Key takeaways

This study evaluates new, custom-fitted breathing masks for children.
Custom masks are designed using 3D facial scans to improve comfort and fit.
It aims to make breathing support more effective for children using NIV.
The study compares custom masks with currently used standard masks.
Children aged 8-12 who use NIV at Stollery Children's Hospital may be eligible.

Who may be eligible?

This study is looking for children aged between 8 and 12 years old. To take part, your child must already be regularly attending the Non-invasive Ventilation clinic at the Stollery Children's Hospital and be using a breathing machine as part of their ongoing treatment plan.

There are a few reasons why a child might not be able to join. For example, if a child has certain developmental or physical difficulties that would make it hard for them to complete the study steps, such as not being able to talk, understand simple instructions, or lie still for a short while, they wouldn't be able to participate. Also, if parents or guardians are unable to read the study information in English, they won't be able to give consent for their child to join.

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 your child aged between 8 and 12 years old?
Does your child regularly attend the Non-invasive Ventilation clinic at the Stollery Children's Hospital?
Does your child currently use a breathing machine (NIV) as part of their treatment?
Can your child understand and follow simple instructions?
Can you, as the parent/guardian, read the study information in English?

Answer every question to see your result.

What does participation involve?

If you decide to take part, your child will first complete some straightforward forms about their health and background. Then, they will have a quick and gentle 3D scan of their face – it's just like having a photo taken but it creates a detailed map of their face. This scan will be used to design their custom breathing mask.

Once the custom mask is ready, we'll do some tests. We'll compare how well your child's current mask works against the new custom mask. We'll check things like air leaks and comfort. Your child will also use both masks, and we'll check information from their breathing machine to see how much they use it. Both you and your child will be asked to fill out questionnaires about comfort, how the mask fits, and any problems experienced. Finally, we'll ask which mask you and your child prefer and why. We don't expect any medication changes as part of this study. The total duration will involve a few appointments over a period of time, which the study team will explain in detail.

Potential risks and benefits

Taking part in this study could potentially lead to your child having a more comfortable and effective breathing mask, which might improve how well their breathing machine works for them. We will be carefully monitoring their comfort and safety throughout. The main risks are minor, such as slight discomfort from wearing a new mask or during the facial scan, which is non-contact. You and your child are free to withdraw from the study at any time, for any reason, without it affecting your child's standard medical care.

Locations (1)

University of Alberta
Verified postcode
Edmonton, Canada· Recruiting

Common questions

What is Non-invasive Ventilation (NIV)?

NIV is a machine that helps people breathe by delivering air pressure through a mask to support their lungs, usually at home.

What is a 'custom mask'?

A custom mask is a breathing mask specifically designed and made to fit the unique shape of an individual child's face, using 3D scanning and printing.

Will this study change my child's regular breathing treatment?

No, this study is about finding a better mask. It won't change the settings of your child's breathing machine or their overall treatment plan.

What does a facial scan involve?

A facial scan is a quick, non-contact process, similar to having a picture taken, that creates a 3D image of your child's face without touching them.

Who can I talk to if I have more questions?

You can always speak with your child's medical team at the Stollery Children's Hospital or contact the research team directly for more information.

How to find out more

Joanna E MacLean, MD, PhD

joanna.maclean@ualberta.ca 780-248-5584 Official trial record

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