Custom Masks for Children Needing Non-Invasive Ventilation

Overseen By Pina Collarusso, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Developmental disabilities, Physical disabilities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to create custom masks for children using non-invasive ventilation (NIV) to enhance comfort and effectiveness. Designers will base the custom masks on a 3D facial scan to better fit children who struggle with their current masks. This approach could prevent discomfort and reduce the need for more invasive procedures like surgery. Children aged 8-12 who already use NIV but have issues with their current mask fit can participate. Participants will compare their usual mask with the custom one to determine which works better for them. As an unphased trial, this study offers a unique opportunity for children to potentially improve their NIV experience with a personalized solution.

Will I have to stop taking my current medications?

The trial protocol does not specify whether participants need to stop taking their current medications.

What prior data suggests that these custom masks are safe for children needing non-invasive ventilation?

Research shows that custom-made 3D-printed masks for non-invasive ventilation (NIV) in children can fit better and feel more comfortable. Studies have found that these masks help prevent air leaks and skin injuries, common problems with regular masks. As a result, children are likely to find these custom masks comfortable to wear.

In earlier studies, adults who used these custom masks reported comfort. The masks, created using 3D printing technology based on detailed facial scans, fit better. Although these studies focused on adults, the results encourage using similar masks for children.

Overall, custom 3D-printed masks appear safe and comfortable, helping to avoid issues that arise with poorly fitting masks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about custom non-invasive ventilation masks for children because they offer a personalized fit based on 3D facial photography, unlike standard commercial masks. This tailored approach can significantly enhance comfort and improve adherence to therapy, addressing a common challenge with existing options. By ensuring a snug fit, these custom masks may also enhance the effectiveness of the ventilation, potentially leading to better health outcomes for children requiring respiratory support.

What evidence suggests that custom NIV masks are effective for improving mask fit in children?

Research has shown that custom-made masks for non-invasive ventilation (NIV), created with 3D printing, can greatly reduce air leaks and increase comfort. In this trial, participants will either receive a custom mask or continue using their current commercial mask. Studies have found that these personalized masks fit better and work more effectively than regular store-bought masks. Early results suggest that these custom masks could help individuals adhere to their NIV therapy by reducing discomfort and side effects. Custom masks have been successfully tested on adults, indicating potential effectiveness for children as well. Overall, evidence suggests that custom masks may help children continue their NIV treatment and avoid more invasive procedures. ^{1 2 3 6 7}

Who Is on the Research Team?

Joanna MacLean, MD, PhD

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

This trial is for children aged 8-12 who are patients at the Stollery Children's Hospital and have been using non-invasive ventilation (NIV) as part of their treatment. They should be established on NIV but not adhering optimally to the therapy.

Inclusion Criteria

You are currently being treated at the Non-invasive ventilation clinic at the Stollery Children's Hospital.

I use a breathing machine as part of my treatment.

I am between 8 and 12 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Mask Fitting and Testing

Participants undergo facial scanning and custom mask fitting, followed by bench testing for leak and comfort parameters.

1 week

1 visit (in-person)

Treatment - Commercial Mask

Participants use their current commercial mask for 2 weeks with compliance monitoring and polysomnography.

2 weeks

1 visit (in-person) for polysomnography

Washout Period

Participants return to using their commercial mask without monitoring to reset conditions before the next phase.

2 weeks

Treatment - Custom Mask

Participants use the custom mask for 2 weeks with compliance monitoring and polysomnography.

2 weeks

1 visit (in-person) for polysomnography

Follow-up

Participants and their parents/guardians complete questionnaires on mask preference, comfort, and any adverse events.

1 month

What Are the Treatments Tested in This Trial?

Interventions

• Custom Non-invasive Ventilation Masks

Trial Overview The study compares custom-made masks, designed from a facial scan for a better fit, with current commercial masks used in NIV for children. It will assess mask leak, comfort, treatment efficacy through sleep studies, compliance data from machines, and user preference.

How Is the Trial Designed?

Group I: Custom mask Experimental Treatment 1 Intervention

Custom mask based on 3D facial photograph for administration of non-invasive ventilation

Group II: Current commercial mask Active Control 1 Intervention

Current commercial mask used by the participant for administration of non-invasive ventilation

Custom Non-invasive Ventilation Masks is already approved in Canada, European Union, United States for the following indications:

Approved in Canada as Custom NIV Masks for:

• Respiratory failure
• Chronic lung conditions
• Sleep-disordered breathing

Approved in European Union as Custom NIV Masks for:

• Respiratory insufficiency
• Neuromuscular diseases
• Obstructive sleep apnea

Approved in United States as Custom NIV Masks for:

• Chronic respiratory conditions
• Pediatric respiratory failure
• Sleep apnea

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Stollery Children's Hospital

Collaborator

Trials

25

Recruited

25,900+

Published Research Related to This Trial

A new pediatric head-lung model was developed using 3D data to simulate non-invasive ventilation (NIV) in a 1-year-old child, which helps in testing the effectiveness of NIV masks.

The study found that a simple anesthetic mask with a 3D-printed quick-release adaptor resulted in significantly lower air leakage compared to a commercial pediatric NIV mask, suggesting it could be a better option for supporting critically ill children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduced Air Leakage During Non-Invasive Ventilation Using a Simple Anesthetic Mask With 3D-Printed Adaptor in an Anthropometric Based Pediatric Head-Lung Model. Hovenier, R., Goto, L., Huysmans, T., et al.[2022]

A 4-year-old boy with a rare condition was successfully treated for acute respiratory failure using a non-invasive ventilation (NIV) system that utilized a simple anesthetic mask and a custom 3D-printed adaptor, highlighting the importance of proper mask fit in pediatric care.

This case demonstrates that alternative NIV interfaces can be effective and suggests that personalized fitting strategies, such as 3D scanning and printing, could improve outcomes for children with specific facial features in the pediatric intensive care unit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-invasive Ventilation for Pediatric Hypoxic Acute Respiratory Failure Using a Simple Anesthetic Mask With 3D Printed Adaptor: A Case Report. Muller, GJ., Hovenier, R., Spijker, J., et al.[2021]

Customized 3D-printed nasal masks significantly improved respiratory parameters in a premature infant weighing less than 1,000 g, reducing the need for supplemental oxygen from 45% to nearly 21%.

The study demonstrates the feasibility of using 3D printing technology to create tailored masks for non-invasive ventilation, suggesting they may be more effective for extremely low birth weight infants compared to traditional masks, leading to a planned clinical trial to further assess safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of three-dimensional nasal imaging and printing in producing customized nasal masks for non-invasive ventilation in extremely low birth weight infant: A pilot study. Martín-Gónzález, A., Morrás de la Torre, B., Bergon-Sendin, E., et al.[2023]

A four-year-old girl with acute lymphocytic leukaemia and severe respiratory failure showed significant improvement in oxygen levels after being treated with non-invasive ventilation (NIV) for six days, indicating its efficacy in such critical cases.

The treatment was well-tolerated with no recorded complications, suggesting that NIV by nasal mask is a safe and feasible option for managing acute respiratory failure in pediatric patients with hematological conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of acute respiratory failure by prolonged non-invasive ventilation in a child. Marino, P., Rosa, G., Conti, G., et al.[2007]

The study developed a fast and efficient method for creating personalized non-invasive ventilation masks for neonates and small infants using 3D scanning and additive manufacturing techniques.

This individualized approach, while potentially more expensive than standard masks, aims to enhance fit and comfort, which could significantly improve the effectiveness of non-invasive ventilation in young patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of Personalized Non-Invasive Ventilation Interfaces for Neonatal and Pediatric Application Using Additive Manufacturing. Bockstedte, M., Xepapadeas, AB., Spintzyk, S., et al.[2022]

Non-invasive ventilation (NIV) is crucial for children with breathing difficulties, but finding well-fitting masks can be challenging, especially for those with small or asymmetrical faces.

The study identified a handheld structured light scanner as the best technology for creating custom-made NIV masks for children, offering superior accuracy, convenience, and cost-effectiveness compared to other scanning methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Custom-made 3D printed masks for children using non-invasive ventilation: a comparison of 3D scanning technologies and specifications for future clinical service use, guided by patient and professional experience. Willox, M., Metherall, P., McCarthy, AD., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10904697/

Development of personalized non-invasive ventilation ... This study aimed to test the air leak and surface pressure performance of personalized oronasal face masks using 3D printed soft materials.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38424411/

Development of personalized non-invasive ventilation ... This study aimed to test the air leak and surface pressure performance of personalized oronasal face masks using 3D printed soft materials.

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05336136/custom-non-invasive-ventilation-masks-in-children

Custom Non-invasive Ventilation Masks in Children Trial Objectives To compare the efficacy of custom NIV masks to commercial masks as measured by efficacy of treatment delivery, compliance, fit ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1389945725002837

Development of an individualized and functional CPAP ... Custom-made 3D printed masks for children using non-invasive ventilation: a feasibility study of production method and testing of outcomes in adult volunteers.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02896751

Use of a 3D Printer to Make Custom Sleep Masks for ... The aim of this study is to improve adherence and effectiveness of noninvasive ventilation by decreasing the side effects commonly seen with noninvasive ...

6. withpower.com withpower.com/trial/phase-non-invasive-ventilation-niv-5-2022-edea9

Custom Masks for Children Needing Non-Invasive Ventilation Research shows that custom 3D-printed masks can improve the fit and comfort of non-invasive ventilation (NIV) for children, reducing air leaks and skin injuries ...

7. researchgate.net researchgate.net/publication/342531314_Custom-made_3D_printed_masks_for_children_using_non-invasive_ventilation_a_feasibility_study_of_production_method_and_testing_of_outcomes_in_adult_volunteers

Custom-made 3D printed masks for children using non- ... Non-invasive ventilation (NIV) is assisted mechanical ventilation delivered via a facemask for people with chronic conditions that affect breathing.