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

Trial Summary

What is the purpose of this trial?

One significant challenge to non-invasive ventilation (NIV) use in children is finding masks to fit a wide range of growing shapes and sizes. While the technology has improved with development of masks specifically for children, the range of options remains limited. Given the smaller size relative to adults, craniofacial abnormalities and craniofacial differences are more likely to compromise mask fit for children. A poor mask fit is uncomfortable, alters delivery of airway pressure, and, in some children, leads to failure of NIV and the need for surgical insertion of an airway in the neck to deliver positive airway pressure through a tracheostomy. This makes expanding the technology to deliver NIV vital and custom NIV masks an exciting solution.In this study, this study will enroll children who are established on long-term NIV with at least some use within 3 months of starting this therapy but who have non-optimal adherence. After consenting to participate and completing demographic and health questionnaire, participants will undergo a facial scan using stereophotogrammetry. This scan will be imported into a computer-aided design software to create a NIV mask customized to the individual face. The steps of mask testing will include: i) Bench testing to compare the leak and comfort parameters of the current commercial mask used by the participant to the custom mask: ii) Efficacy of treatment as measured by polysomonography iii) NIV compliance from machine downloads; iv) Questionnaires to assess the subjective comfort, fit, and adverse events Finally, participants and their parents/guardian will be asked which mask they prefer and why.

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 data supports the effectiveness of the treatment Custom Non-invasive Ventilation Masks for children?

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. A study found that using a 3D-printed mask in a premature infant improved breathing and reduced the need for extra oxygen, suggesting these masks may be more effective than standard ones. ^{1 2 3 4 5}

Is it safe to use custom 3D-printed masks for non-invasive ventilation in children?

Research shows that custom 3D-printed masks for non-invasive ventilation in children can reduce air leaks and improve comfort, which are important for safety. However, more studies are needed to fully understand their safety in different situations. ^{1 3 4 5 6}

How is the Custom Non-invasive Ventilation Masks treatment different from other treatments for children needing non-invasive ventilation?

Custom Non-invasive Ventilation Masks are unique because they are 3D printed to fit each child's specific facial features, reducing air leaks and improving comfort compared to standard mass-produced masks. This personalized approach ensures a better fit, which is crucial for effective treatment in children with unique facial structures. ^{1 2 4 5 6}

Research Team

Joanna MacLean, MD, PhD

Principal Investigator

University of Alberta

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. Switzerland 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. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Treatment of acute respiratory failure by prolonged non-invasive ventilation in a child. [2007]

3. Singapore 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. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Development of Personalized Non-Invasive Ventilation Interfaces for Neonatal and Pediatric Application Using Additive Manufacturing. [2022]

5. England 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. [2021]

6. Switzerland 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. [2022]