Clinical trial NCT05513508 - References

Pressure Ulcer — The ROTAtional-USE of Interface STUDY

Citation(s)

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  New treatment of acute hypoxemic respiratory failure: noninvasive pressure support ventilation delivered by helmet--a pilot controlled trial. Crit Care Med. 2002 Mar;30(3):602-8. doi: 10.1097/00003246-200203000-00019.
•   Antonelli M, Pennisi MA, Pelosi P, Gregoretti C, Squadrone V, Rocco M, Cecchini L, Chiumello D, Severgnini P, Proietti R, Navalesi P, Conti G
  Noninvasive positive pressure ventilation using a helmet in patients with acute exacerbation of chronic obstructive pulmonary disease: a feasibility study. Anesthesiology. 2004 Jan;100(1):16-24. doi: 10.1097/00000542-200401000-00007.
•   Bashir T, Murki S, Kiran S, Reddy VK, Oleti TP
  'Nasal mask' in comparison with 'nasal prongs' or 'rotation of nasal mask with nasal prongs' reduce the incidence of nasal injury in preterm neonates supported on nasal continuous positive airway pressure (nCPAP): A randomized controlled trial. PLoS One. 2019 Jan 31;14(1):e0211476. doi: 10.1371/journal.pone.0211476. eCollection 2019.
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  The cost of pressure ulcers in the UK. Age Ageing. 2004 May;33(3):230-5. doi: 10.1093/ageing/afh086.
•   Brill AK
  How to avoid interface problems in acute noninvasive ventilation. Breathe 2014;10:230-242
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  Noninvasive ventilation for patients with hypoxemic acute respiratory failure. Semin Respir Crit Care Med. 2014 Aug;35(4):492-500. doi: 10.1055/s-0034-1383863. Epub 2014 Aug 11.
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•   Cai JY, Zha ML, Chen HL
  Use of a Hydrocolloid Dressing in the Prevention of Device-related Pressure Ulcers During Noninvasive Ventilation: A Meta-analysis of Randomized Controlled Trials. Wound Manag Prev. 2019 Feb;65(2):30-38.
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•   Curtis JR, Cook DJ, Sinuff T, White DB, Hill N, Keenan SP, Benditt JO, Kacmarek R, Kirchhoff KT, Levy MM; Society of Critical Care Medicine Palliative Noninvasive Positive VentilationTask Force
  Noninvasive positive pressure ventilation in critical and palliative care settings: understanding the goals of therapy. Crit Care Med. 2007 Mar;35(3):932-9. doi: 10.1097/01.CCM.0000256725.73993.74.
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•   da Cunha-Martins, B
  S.M., Motta-Ribeiro, G.C. & Jandre, F.C. Short-term usage of three non-invasive ventilation interfaces causes progressive discomfort in healthy adults. Res. Biomed. Eng. 37, 289-298 (2021)
•   Davidson AC, Banham S, Elliott M, Kennedy D, Gelder C, Glossop A, Church AC, Creagh-Brown B, Dodd JW, Felton T, Foex B, Mansfield L, McDonnell L, Parker R, Patterson CM, Sovani M, Thomas L; BTS Standards of Care Committee Member, British Thoracic Society/Intensive Care Society Acute Hypercapnic Respiratory Failure Guideline Development Group, On behalf of the British Thoracic Society Standards of Care Committee
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•   Gorecki C, Brown JM, Nelson EA, Briggs M, Schoonhoven L, Dealey C, Defloor T, Nixon J; European Quality of Life Pressure Ulcer Project group
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•   Hess DR
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•   Holanda MA, Reis RC, Winkeler GF, Fortaleza SC, Lima JW, Pereira ED
  Influence of total face, facial and nasal masks on short-term adverse effects during noninvasive ventilation. J Bras Pneumol. 2009 Feb;35(2):164-73. doi: 10.1590/s1806-37132009000200010.
•   Lemyze M, Mallat J, Nigeon O, Barrailler S, Pepy F, Gasan G, Vangrunderbeeck N, Grosset P, Tronchon L, Thevenin D
  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 Feb;41(2):481-8. doi: 10.1097/CCM.0b013e31826ab4af.
•   Longhini F, Liu L, Pan C, Xie J, Cammarota G, Bruni A, Garofalo E, Yang Y, Navalesi P, Qiu H
  Neurally-Adjusted Ventilatory Assist for Noninvasive Ventilation via a Helmet in Subjects With COPD Exacerbation: A Physiologic Study. Respir Care. 2019 May;64(5):582-589. doi: 10.4187/respcare.06502. Epub 2019 Feb 12.
•   Mehta S, Hill NS
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•   Navalesi P, Fanfulla F, Frigerio P, Gregoretti C, Nava S
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•   Newnam KM, McGrath JM, Salyer J, Estes T, Jallo N, Bass WT
  A comparative effectiveness study of continuous positive airway pressure-related skin breakdown when using different nasal interfaces in the extremely low birth weight neonate. Appl Nurs Res. 2015 Feb;28(1):36-41. doi: 10.1016/j.apnr.2014.05.005. Epub 2014 Jun 5.
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•   Scala R, Accurso G, Ippolito M, Cortegiani A, Iozzo P, Vitale F, Guidelli L, Gregoretti C
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•   Schallom M, Cracchiolo L, Falker A, Foster J, Hager J, Morehouse T, Watts P, Weems L, Kollef M
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  Noninvasive positive pressure ventilation reverses acute respiratory failure in select "do-not-intubate" patients. Crit Care Med. 2005 Sep;33(9):1976-82. doi: 10.1097/01.ccm.0000178176.51024.82.
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  Outcomes of COVID-19 patients treated with continuous positive airway pressure outside the intensive care unit. ERJ Open Res. 2021 Jan 25;7(1):00541-2020. doi: 10.1183/23120541.00541-2020. eCollection 2021 Jan.
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A Pragmatic Open Label, Multi-center, Spontaneous, No-profit, Randomized Controlled Clinical Trial With Non-significant Risk Medical Device on the Rotational Use of Interfaces Versus Standard of Care for Patients Treated With NPPV for AHRF.

Details for clinical trial NCT05513508