Pilot evaluation of 3D-designed custom-made integrated mask and headgear for children using non-invasive ventilation

<h4>Objectives </h4> Use of long-term non-invasive ventilation (NIV) for children is increasing. Standard masks often fit poorly, causing significant complications. This pilot study aimed to evaluate a customised NIV mask/headgear. <h4>Setting </h4> The evaluation took place in a single tertiary care centre. <h4>Participants </h4> Five children aged 2–15 years using NIV for respiratory support and for whom a well-fitting commercial mask could not be found completed the study. Those requiring ventilation for rescue breaths or supplementary oxygen were excluded. <h4>Intervention </h4> Each participant received a 3D-designed NIV mask and headgear, customised to the individual using 3D scanning and computer-aided design. The custom mask and headgear were compared with the child’s usual mask and headgear for two nights each. <h4>Primary and secondary outcome measures </h4> The primary outcome measure was comfort, measured using a 7-point Likert scale; secondary outcome measures were facial skin marks, measured using a diary card; ventilator efficacy, measured by 4% oxygen desaturation index (ODI 4 ) and sleep quality, measured by actigraphy recordings of overnight ‘Actual Wake’. <h4>Results Compared with the usual mask/headgear, the median discomfort score using the custom mask/headgear reduced from 5 Likert points (IQR 0) to 3 (IQR 2), and facial skin sores reduced from 1.5 (IQR 3) to 1 (IQR 0). Median Oxygen Desaturation Index (ODI 4 ) was similar: 0.76 (IQR 0.8) with standard mask/headgear and 0.77 (IQR 0.71) with the custom mask/headgear and median Actual Wake % was 2.95 (IQR 2.31) with standard mask/headgear and 3.70 (IQR 4.85) with the custom mask/headgear. <h4>Conclusions</h4> Customisation of NIV masks and headgear using 3D printing may provide a valuable solution for children for whom a well-fitting commercial mask cannot be found. A multicentre study will seek to clarify definitive outcomes.