Custom non-invasive ventilation masks for children
Custom Non-invasive Ventilation Masks in Children
This study is testing custom-made ventilation masks for kids aged 8-12 to see if better fitting masks can help them feel more comfortable and stick to their treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 8 Years to 12 Years |
| Sex | All |
| Sponsor | University of Alberta Academic / other |
| Locations | 1 site (Edmonton, Alberta) |
| Trial ID | NCT05336136 on ClinicalTrials.gov |
What this trial studies
This study focuses on creating custom non-invasive ventilation (NIV) masks tailored to the unique facial features of children aged 8-12 who are already using NIV. Using advanced 3D scanning technology, facial scans will be taken to design masks that fit better than standard options, potentially improving comfort and adherence to treatment. The custom masks will be manufactured using 3D printing techniques and medical-grade materials. The goal is to enhance the effectiveness of NIV therapy in children by addressing the common issue of poor mask fit.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 8-12 who are established on long-term non-invasive ventilation and have experienced non-optimal adherence.
Not a fit: Patients with developmental or physical disabilities that hinder their ability to participate in the study protocol may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve adherence to non-invasive ventilation therapy in children, leading to better health outcomes.
How similar studies have performed: Previous studies have suggested that customized approaches to NIV mask selection can improve comfort and adherence, indicating potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children between 8-12 years of age * Followed clinically by the Non-invasive ventilation clinic at the Stollery Children's Hospital * Established on non-invasive ventilation as part of their treatment plan. Exclusion Criteria: * Children with developmental or physical disabilities that would prevent their successful completion of the study protocol (e.g., non-verbal, unable to follow 3-step commands, unalbe to lie still for 20 min). * Children whose parent/guardian are unable to provide consent because of an inability to read the study documents in english.
Where this trial is running
Edmonton, Alberta
- University of Alberta — Edmonton, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Joanna E MacLean, MD, PhD — University of Alberta
- Study coordinator: Joanna E MacLean, MD, PhD
- Email: joanna.maclean@ualberta.ca
- Phone: 780-248-5584
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.