Medical Devices: Evidence and Research (Nov 2016)
Investigating the effects of strap tension during non-invasive ventilation mask application: a combined biomechanical and biomarker approach
Abstract
Peter R Worsley, George Prudden, George Gower, Dan L Bader Southampton General Hospital, Clinical Academic Facility, Faculty of Health Sciences, University of Southampton, Southampton, UK Abstract: Non-invasive ventilation is commonly used for respiratory support. However, in some cases, mask application can cause pressure ulcers to specific features of the face, resulting in pain and reduced quality of life for the individual. This study investigated the effects of mask strap tension on the biomechanical and biomarker responses at the skin interface. Healthy participants (n=13) were recruited and assigned two different masks in a random order, which were fitted with three strap conditions representing increments of 5 mm to increase tension. Masks were worn for 10 minutes at each tension followed by a 10-minute refractory period. Assessment at the device–skin interface included measurements of pressures at the nose and cheeks, temperature and humidity, a selection of inflammatory cytokine concentrations collected from sebum and scores of comfort. The results indicated significantly higher interface pressures at the bridge of the nose compared to the cheeks for both masks (p<0.05), with nasal interface pressures significantly increasing with elevated strap tension (p<0.05). One inflammatory cytokine, IL-1α, increased following mask application at the highest tension, with median increases from baselines ranging from 21 to 33%. The other cytokines revealed a less consistent trend with strap tension. The participants reported statistically greater discomfort during elevated strap tension. Temperature and humidity values under the mask were elevated from ambient conditions, although no differences were observed between mask type or strap tension. The bony prominence on the bridge of the nose represented a vulnerable area of skin during respiratory mask application. This study has shown that mask strap tension has a significant effect on the pressure exerted on the nose. This can result in discomfort and an inflammatory response at the skin surface. Further studies are required to investigate respiratory mask application for appropriate individuals with comorbidities. Keywords: medical device, pressure ulcers, respiratory masks, non-invasive ventilation, biomarkers
