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Borràs-Novell, et al.
               Finally, the physical characteristics of the 3D printed   tailor-made masks in optimizing patient’s ventilation, and
           prototype allow the incorporation of an adhesive silicone   especially their ability to reduce skin ulcerations.
           strip in the contour that rests on manikin; this strip does not
           damage the skin when it is removed. This extra adherence   4. Conclusions
           may reduce damage caused by friction mechanisms, instead   Our research team has tested and validated the technical
           of pressure mechanisms. Willox et al. added granuflexv to   viability  of designing and printing silicone tailor-made
           their printed prototype to cushion the edges as the mask   3D  facial masks  for NIV to a very preterm manikin
           seems more rigid . The adhesive silicone strip could also   (Anne Premature from Laerdel ). The customization of
                         [8]
                                                                                         ®
           be used in commercially available masks.            these non-invasive masks allows perfect fit of the specific
               The  use of a resuscitation  manikin  in this study   anatomic  features  of  any  given  patient’s  face.  In  near
           enabled us to connect a ventilation system to the manikin   future,  these  tailor-made  masks could  reduce  air  leaks
           to check the correct thoracic excursion with the use of   and allow for a homogeneous distribution of pressure on
           a  tailor-made  mask.  However, due  to  such  use of the   the skin, thereby optimizing NIV and reducing the risk
           phantom, other ventilatory parameters could not be tested.  for skin ulcers, respectively.
               3D printing can also become a potentially useful tool
           for both patients and health personnel in the background   Acknowledgments
           of  the  COVID-19  pandemic.  Individualized  printed
           masks represent an improvement  in NIV therapies  for   The authors would like to thank Avinent Implant System
           patients affected by respiratory failure. On the other hand,   S.L.U. and  Elkem  Silicones  France  SAS, especially
           customized masks could also play a role in the protection   Lauriane  Depernon  (Technical  Service  Manager  Skin
           of healthcare personnel; some studies have demonstrated   Adhesives - Compentence Center – ATRiON), for their
           the application of 3D printing in the development  of   technological support and knowledge in the development
           personal protective equipment and respiratory protective   of this project.
           devices [7,17-19] .                                     The authors would like also to thank to the Skin
               At the end of the study, we estimated that the price of   Adverse  Events’  Working  Group  of  the  Neonatology
           making an individualized mask was 80 euros at the time.   Department  of Hospital Clínic for their  collaboration,
           To  prevent  NIV-related  skin  ulcerations,  our  hospital’s   their expertise has been fundamental.
           protocol recommends the alternative use of two generic
           nasal masks of different sizes in every infant (these masks   Funding
           need to be renewed every 5 days). The total NIV days in   Our  project  was  granted  by  research  aid Adolfo Valls-
           our department are around 600 days/year, corresponding   Respisurf of the Spanish Society of Neonatology (edition
           to the use of approximately 250 standardized masks. This   2018).
           price is, in general terms, higher than that of standardized
           masks (in our case, it is 4 times higher), but we believe   Conflict of interest
           that the cost can be substantially reduced by automating
           the design phase and by having the printer available in   Authors Cristina Borràs-Novell, Mario García Causapié
           the hospital. Potential clinical benefits from tailor-made   and Oscar García-Algar do not have conflicts of interest.
           masks can lead to a favorable cost/benefit ratio.   Authors Maria Murcia and Damien Djian work in Elkem
               The  next  step  of  our  research  team  is  to  test  the   Company as Sales Manager HC&IAM Iberia and Sales
           viability of the process in very preterm infants admitted   Expert  3D  printing  Europa  and  R&I  –  Compentence
           in our department.  This will include the previously   Center – ATRiON respectively. The mentioned companies
           mentioned steps (3D facial scan, image processing, and   had altruist collaboration in the current project, within the
           3D printing process) by following the same methodology.   framework of Research & Development.
           To make sure very preterm infants could eventually benefit   Author contributions
           from  these  tailor-made  masks  as  soon as  possible,  the
           team is dedicated to shortening the time that it currently   C.B.N. literature review, image capture, prototype design
           takes  to produce  each  mask  by automating  the  design   corrections,  prototype  tests,  data  management,  data
           phase. This new proposed project will be presented to the   interpretation, draft manuscript, consolidation of coauthor
           ethics committee of our hospital. Once ethical approval   comments, and paper finalization. M.G.C. image capture,
           is granted by the  research  ethics  committee,  we will   prototype design, prototype tests, data interpretation, and
           conduct a clinical study to test the resulting tailor-made,   manuscript review. M.M prototype design and manuscript
           3D-printed NIV masks and compare their effectiveness   review. D.D. prototype  design, prototype  printing,  and
           and  safety  versus the  standardized  masks.  The  key   manuscript  review.  O.G.A.  conceptualization,  work
           endpoints of the project are related to the ability of the   coordination, and manuscript review.


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