Non-invasive ventilation (NIV) is assisted respiratory support delivered via facemask for people with chronic respiratory failure. Commercial NIV masks are available but masks that fit well are difficult to find for children who have small or asymmetrical facial features. Compromised ventilation can have significant health and quality of life impacts for patients and their families.
The overarching aim of the project was to improve comfort, fit and performance of NIV masks for children using 3D technology.
The needs of patients, parents/carers and healthcare professionals from 6 UK centres was ensured through events advising on mask design and research procedures. 3D scanning technologies were compared in vitro using workflows and deviation analysis and with 3 healthy and 19 patient volunteers. Early design concepts were tested and the final prototype selected using a test mannequin and adult volunteers. Prototype masks were manufactured using biocompatible materials to IOS 13485 quality standards and evaluated with 19 patients. Feedback on fit, comfort and facial marking and oxicapnography data to demonstrate ventilator effectiveness were collected. The potential cost-effectiveness of the customised masks was assessed using an economic model.
A handheld structured light 3D scanner was selected due to superior resolution, ease of use, availability and cost. The final design was a semi-bespoke hybrid approach. 11/15 (73%) evaluation participants reported comfort and fit that was as good or better than their usual mask. 5/11 (45%) were unable to wear the mask due to poorly fitting headgear despite a well-fitting mask. All physiological ventilation parameters were improved (table 1). Preliminary health economics analysis demonstrated that to achieve a 5% improvement in fit and ventilation, a custom-made mask would be cost effective at a price below £500.
A series of in vitro, user-perspective, healthy volunteer and patient evaluations informed the development of custom-made masks for children using NIV.
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