TY - JOUR T1 - Development of Personalized Fitting Device With 3-Dimensional Solution for Prevention of NIV Oronasal Mask-Related Pressure Ulcers JF - Respiratory Care SP - 1024 LP - 1032 DO - 10.4187/respcare.05691 VL - 63 IS - 8 AU - Maiko Shikama AU - Gojiro Nakagami AU - Hiroshi Noguchi AU - Taketoshi Mori AU - Hiromi Sanada Y1 - 2018/08/01 UR - http://rc.rcjournal.com/content/63/8/1024.abstract N2 - BACKGROUND: Pressure ulcers related to oronasal masks used with noninvasive ventilation (NIV), along with patient discomfort, occur due to improper fit of the mask. We developed a personalized fitting device using a 3-dimensional (3D) scanning solution to prevent the formation of NIV mask-related pressure ulcers. This study aimed to evaluate the effectiveness of the proposed personalized fitting device.METHODS: We conducted a randomized crossover experimental study of 20 healthy participants to study the use of this personalized fitting device between the face and an NIV mask designed with 3D solutions. The fitting device was not used under the NIV mask for the control. The outcome measures were the presence of blanchable erythema, standardized redness intensity, discomfort level, and contact pressure.RESULTS: The incidence of blanchable erythema and standardized redness intensity values were significantly lower for subjects who used the fitting device when worn for 30 min (P < .001). The discomfort levels at the forehead, nasal bridge, and both cheeks, as well as leakage, were significantly reduced as well (P = .008, P < .001, P = .001, P = .002, P = .001, P = .02, P < .001, P < .001, P < .001). Contact pressure at the nasal bridge, where pressure ulcers most frequently develop, was significantly decreased with the fitting device (P < .001).CONCLUSIONS: Personalized fitting devices that incorporate 3D scanning solutions may contribute to the prevention of NIV mask-related pressure ulcers and the reduction of discomfort. ER -