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.
PittmanJ, BeesonT, KittermanJ, LancasterS, ShellyA. Medical device–related hospital-acquired pressure ulcers: development of an evidence-based position statement. J Wound Ostomy Continence Nurs, 2015; 42(2):151–154.
2.
MurrayJS, NoonanC, QuigleyS, CurleyMA. Medical device–related hospital-acquired pressure ulcers in children: an integrative review. J Pediatr Nurs, 2013; 28(6):585–595.
3.
ApoldJ, RydrychD. Preventing device-related pressure ulcers: using data to guide statewide change. J Nurs Care Qual, 2012; 27(1):28–34.
4.
VanGilderC, AmlungS, HarrisonP, MeyerS. Results of the 2008-2009 International Pressure Ulcer Prevalence Survey and a 3-year, acute care, unit-specific analysis. Ostomy Wound Manage, 2009; 55(11):39–45.
5.
CoyerFM, StottsNA, BlackmanVS. A prospective window into medical device–related pressure ulcers in intensive care. Int Wound J, 2014; 11(6):656–664.
FaurouxB, LavisJF, NicotF, PicardA, BoellePY, ClementA, et al. Facial side effects during noninvasive positive pressure ventilation in children. Intensive Care Med, 2005; 31(7):965–969.
8.
RathoreFA, AhmadF, ZahoorMU. Case report of a pressure ulcer occurring over the nasal bridge due to a non-invasive ventilation facial mask. Cureus, 2016; 8(10):e813.
9.
LemyzeM, MallatJ, NigeonO, BarraillerS, PepyF, GasanG, et al. Rescue therapy by switching to total face mask after failure of face mask-delivered noninvasive ventilation in do-not-intubate patients in acute respiratory failure. Crit Care Med, 2013; 41(2):481–488.
10.
VisscherMO, WhiteCC, JonesJM, CahillT, JonesDC, PanBS. Face masks for noninvasive ventilation: fit, excess skin hydration, and pressure ulcers. Respir Care, 2015; 60(11):1536–1547.
11.
SchallomM, CracchioloL, FalkerA, FosterJ, HagerJ, MorehouseT, et al. Pressure ulcer incidence in patients wearing nasal-oral versus full-face noninvasive ventilation masks. Am J Crit Care, 2015; 24(4):349–356.
12.
KemalettinY, AykutÖ, ÇetinD, EthemG. An unusual location for a pressure ulcer: the nasal bridge. Wounds, 2013; 25(8):E9–E10.
13.
BrillAK. How to avoid interface problems in acute noninvasive ventilation. Breathe, 2014; 10(3):230–242.
14.
WengMH. The effect of protective treatment in reducing pressure ulcers for non-invasive ventilation patients. Intensive Crit Care Nurs, 2008; 24(5):295–299.
15.
Raurell-TorredaM, Argilaga-MoleroE, Colomer-PlanaM, Rodenas-FransicoA, Ruiz-GarciaMT, Uya MuntanaJ. Optimising non-invasive mechanical ventilation: which unit should care for these patients? A cohort study. Aust Crit Care, 2017; 30(4):225–233.
16.
SchettinoGP, TucciMR, SousaR, Valente BarbasCS, Passos AmatoMB, CarvalhoCR. Mask mechanics and leak dynamics during noninvasive pressure support ventilation: a bench study. Intensive Care Med, 2001; 27(12):1887–1891.
17.
DellwegD, HochrainerD, KlaukeM, KerlJ, EigerG, KohlerD. Determinants of skin contact pressure formation during non-invasive ventilation. J Biomech, 2010; 43(4):652–657.
18.
NavaS, NavalesiP, GregorettiC. Interfaces and humidification for noninvasive mechanical ventilation. Respir Care, 2009; 54(1):71–84.
19.
YamagutiWP, ModernoEV, YamashitaSY, GomesTG, MaidaAL, KondoCS, et al. Treatment-related risk factors for development of skin breakdown in subjects with acute respiratory failure undergoing noninvasive ventilation or CPAP. Respir Care, 2014; 59(10):1530–1536.
20.
Da SilveiraAC, DawJLJr., KusnotoB, EvansC, CohenM. Craniofacial applications of three-dimensional laser surface scanning. J Craniofac Surg, 2003; 14(4):449–456.
21.
RanaM, GellrichN-C, von SeeC, WeiskopfC, GerressenM, GhassemiA, et al. 3D evaluation of postoperative swelling in treatment of bilateral mandibular fractures using 2 different cooling therapy methods: a randomized observer blind prospective study. J Cranio-Maxillofacial Surg, 2013; 41(1):e17–e23.
22.
AmiravI, LuderAS, HalamishA, RavivD, KimmelR, WaismanD, et al. Design of aerosol face masks for children using computerized 3D face analysis. J Aerosol Med Pulm Drug Deliv, 2014; 27(4):272–278.
23.
CarrollA, AmiravI, MarchandR, OlmsteadD, LoganH, GrosvenorA, et al. Three-dimensional modeled custom-made noninvasive positive pressure ventilation masks in an infant. Am J Respir Crit Care Med, 2014; 190(8):950.
24.
HsuD-Y, ChengY-L, BienM-Y, LeeH-C. Development of a method for manufacturing customized nasal mask cushion for CPAP therapy. Australas Phys Eng Sci Med, 2015; 38(4):657–664.
25.
NavalesiP, FanfullaF, FrigerioP, GregorettiC, NavaS. Physiologic evaluation of noninvasive mechanical ventilation delivered with three types of masks in patients with chronic hypercapnic respiratory failure. Crit Care Med, 2000; 28(6):1785–1790.
26.
GiraultC, BrielA, BenichouJ, HellotMF, DachraouiF, TamionF, et al. Interface strategy during noninvasive positive pressure ventilation for hypercapnic acute respiratory failure. Crit Care Med, 2009; 37(1):124–131.
27.
BlackJM, CuddiganJE, WalkoMA, DidierLA, LanderMJ, KelpeMR. Medical device related pressure ulcers in hospitalized patients. Int Wound J, 2010; 7(5):358–365.
28.
HanonuS, KaradagA. A prospective, descriptive study to determine the rate and characteristics of and risk factors for the development of medical device–related pressure ulcers in intensive care units. Ostomy Wound Manage, 2016; 62(2):12–22.
29.
MakicMB. Medical device–related pressure ulcers and intensive care patients. J Perianesth Nurs, 2015; 30(4):336–337.
30.
YamamotoT, TakiwakiH, AraseS, OhshimaH. Derivation and clinical application of special imaging by means of digital cameras and Image J freeware for quantification of erythema and pigmentation. Skin Res Technol, 2008; 14(1):26–34.
31.
ShikamaM, NakagamiG, NoguchiH, MoriT, SanadaH. Development of personalized fitting device with three-dimensional solution for preventing medical device–related pressure ulcers caused by oral-nasal mask during noninvasive positive pressure ventilation: a preliminary study (abstract). J Japan Soc Wound Ostomy Continence Manage, 2016; 20(2):185.
32.
DyerA. Ten top tips Preventing device-related pressure ulcers. Wounds In, 2015; 6(1):9–13.
33.
SugamaJ, SanadaH, TakahashiM. Reliability and validity of a multi-pad pressure evaluator for pressure ulcer management. J Tissue Viability, 2002; 12(4):148–153.
34.
BambiS, PerisA, EsquinasAM. Pressure ulcers caused by masks during noninvasive ventilation (letter). Am J Crit Care, 2016; 25(1):6.
