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

Objectives

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.

Setting

The evaluation took place in a single tertiary care centre.

Participants

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.

Intervention

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.

Primary and secondary outcome measures

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 (ODI4) and sleep quality, measured by actigraphy recordings of overnight ‘Actual Wake’.

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 (ODI4) 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.

Conclusions

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.