The ROTAtional-USE of Interface STUDY

NCT05513508 | Recruiting DMC

• 1 other identifier: 062.373
• Study Type: interventional
• Target: 478
• Locations: 1 country
• Sites: 1

Brief Summary

In this trial investigators will explore if a protocolized rotational use of interfaces i.e., masks, during noninvasive positive pressure ventilation (NPPV) compared to standard care is clinically effective and cost-effective in reducing the incidence of pressure sores in patients with hypercapnic acute respiratory failure (AHRF) treated continuously i.e., for more than 24 hours, with NPPV (to avoid intubation, as alternative to invasive ventilation and after early extubation and weaning).

Conditions

Pressure Ulcer; Noninvasive Positive Pressure Ventilation; Acute Hypercapnic Respiratory Failure

Keywords

Rotational use of noninvasive interfaces

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who develop new pressure sores

  To determine if a protocolized rotational use of interfaces during NPPV compared to standard care is effective in reducing the development of new pressure sores in patients with AHRF treated continuously i.e., for more than 24 hours, with NIV (to avoid intubation, as alternative to invasive ventilation, and during early extubation and weaning).

  At 36 hours from randomization

Secondary Outcomes (4)

• Onset of pressure sores at different timepoints

  At 12, 24, 36, 48, 60, 72, 84, 96 hours from the randomization

• Number, stage and location of pressure sores

  At 12, 24, 36, 48, 60, 72, 84, 96 hours from the randomization

• NPPV treatment interruption

  At 12, 24, 36, 48, 60, 72, 84, 96 hours from the randomization

• Cost-effectiveness analysis

  At 12, 24, 36, 48, 60, 72, 84, 96 hours from the randomization

Study Arms (2)

Intervention group

EXPERIMENTAL

In the intervention group the first mask will be randomly chosen between the two most used in that center among those available i.e., oro-nasal, total face or hybrid mask. Thereafter, NPPV mask will be changed every 6 hours, alternating the two different interfaces. Patients wearing oro-nasal masks will receive protective dressings on nasal bridge before starting NPPV.

Procedure: Protocolized rotational use of interfaces

Control group

ACTIVE COMPARATOR

In the control group, mask will be chosen according to the standard of care of the participating centers among the three types of masks available i.e., oro-nasal, total face or hybrid mask. Patients wearing oro-nasal masks will receive protective dressings on nasal bridge before starting NPPV. Interface will be changed in case of discomfort judged by the patient as unbearable or in case of the presence of a pressure sore.

Procedure: Standard of care

Interventions

Protocolized rotational use of interfaces PROCEDURE

The NIV mask will be changed every 6 hours, alternating two different interfaces between the two most used in that center among those available i.e., oro-nasal, total face or hybrid mask.

Intervention group

Standard of care PROCEDURE

Mask will be chosen according to the standard of care of the participating centers among the three types of masks available i.e., oro-nasal, total face or hybrid mask. Interface will be changed in case of discomfort judged by the patient as unbearable or in case of the presence of a pressure sore.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age\>18 years old
• Patients with chronic obstructive pulmonary disease (COPD) exacerbation or with AHRF of a different etiology needing NPPV to avoid intubation (pH \< 7.35 with PaCO2 \> 45 mmHg and partial pressure of oxygen (PaO2) \< 65 mmHg plus respiratory rate \> 25 breath/min with clinical signs of respiratory muscle distress); or as alternative to invasive ventilation with a forecast of treatment of at least 24 hours admitted to the intensive care unit, intermediate respiratory care unit, respiratory medicine service or internal medicine service according to hospital organization; or patients with chronic pulmonary disease intubated for a COPD exacerbation or for pneumonia who are early extubated and weaned in the intensive care unit with NPPV with a forecast of treatment of at least 24 hours.

You may not qualify if:

• Patient with skin breakdown or non-blanchable erythema in one of the following areas i.e., nasal bridge, nasolabial fold, cheek or scalp at hospital entrance;
• Patients who refuse to consent to the study protocol;
• Patient known to be pregnant;
• Patients with contraindication to NPPV (lack of spontaneous breathing; gasping; anatomical or functional airway obstruction; gastrointestinal bleeding or ileus; coma; massive agitation; massive retention of secretions despite bronchoscopy and aggressive physiotherapy; hemodynamic instability (cardiogenic shock, myocardial infarction); status post upper gastrointestinal surgery);
• Patients entering hospital with asthma, with cardiogenic pulmonary edema;
• Patients with tracheostomy;
• Patients needing NPPV only for palliation of symptoms (relief of dyspnea) i.e., category 3 defined by the Task Force on the Palliative Use of NPPV of the Society of Critical Care Medicine;
• Use of high flow nasal cannula integrated with NPPV for weaning strategy;
• Pre-existing skin erythematosus diseases;
• Known hypersensitivity to skin protective devices (i.e., polyurethan films, colloids, foams);
• More than 2 hours of NPPV application before randomization;
• Patients already included in the study protocol at an earlier stage of the hospitalization;
• Refuse to wear NPPV interface due to comfort;

Sponsors & Collaborators

• Azienda Ospedaliero Universitaria Maggiore della Carita: lead
• Università degli Studi del Piemonte Orientale Amedeo Avogadro: collaborator

Study Sites (1)

Ospedale Maggiore della Carità

Novara, 28100, Italy

RECRUITING

Related Publications (46)

• Davidson C, Banham S, Elliott M, Kennedy D, Gelder C, Glossop A, Church C, Creagh-Brown B, Dodd J, Felton T, Foex B, Mansfield L, McDonnell L, Parker R, Patterson C, Sovani M, Thomas L. British Thoracic Society/Intensive Care Society Guideline for the ventilatory management of acute hypercapnic respiratory failure in adults. BMJ Open Respir Res. 2016 Mar 14;3(1):e000133. doi: 10.1136/bmjresp-2016-000133. eCollection 2016. No abstract available.

  PMID: 27026806 BACKGROUND

• Burns KE, Meade MO, Premji A, Adhikari NK. Noninvasive ventilation as a weaning strategy for mechanical ventilation in adults with respiratory failure: a Cochrane systematic review. CMAJ. 2014 Feb 18;186(3):E112-22. doi: 10.1503/cmaj.130974. Epub 2013 Dec 9.

  PMID: 24324020 BACKGROUND

• Vaschetto R, Pecere A, Perkins GD, Mistry D, Cammarota G, Longhini F, Ferrer M, Pletsch-Assuncao R, Carron M, Moretto F, Qiu H, Della Corte F, Barone-Adesi F, Navalesi P. Effects of early extubation followed by noninvasive ventilation versus standard extubation on the duration of invasive mechanical ventilation in hypoxemic non-hypercapnic patients: a systematic review and individual patient data meta-analysis of randomized controlled trials. Crit Care. 2021 Jun 1;25(1):189. doi: 10.1186/s13054-021-03595-5.

  PMID: 34074314 BACKGROUND

• Cabrini L, Esquinas A, Pasin L, Nardelli P, Frati E, Pintaudi M, Matos P, Landoni G, Zangrillo A. An international survey on noninvasive ventilation use for acute respiratory failure in general non-monitored wards. Respir Care. 2015 Apr;60(4):586-92. doi: 10.4187/respcare.03593. Epub 2014 Nov 18.

  PMID: 25406347 BACKGROUND

• Vaschetto R, Barone-Adesi F, Racca F, Pissaia C, Maestrone C, Colombo D, Olivieri C, De Vita N, Santangelo E, Scotti L, Castello L, Cena T, Taverna M, Grillenzoni L, Moschella MA, Airoldi G, Borre S, Mojoli F, Della Corte F, Baggiani M, Baino S, Balbo P, Bazzano S, Bonato V, Carbonati S, Crimaldi F, Daffara V, De Col L, Maestrone M, Malerba M, Moroni F, Perucca R, Pirisi M, Rondi V, Rosalba D, Vanni L, Vigone F, Navalesi P, Cammarota G. 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.

  PMID: 33527074 BACKGROUND

• Nava S, Navalesi P, Conti G. Time of non-invasive ventilation. Intensive Care Med. 2006 Mar;32(3):361-70. doi: 10.1007/s00134-005-0050-0. Epub 2006 Feb 14.

  PMID: 16477416 BACKGROUND

• Mehta S, Hill NS. Noninvasive ventilation. Am J Respir Crit Care Med. 2001 Feb;163(2):540-77. doi: 10.1164/ajrccm.163.2.9906116. No abstract available.

  PMID: 11179136 BACKGROUND

• Hess DR. Noninvasive positive-pressure ventilation and ventilator-associated pneumonia. Respir Care. 2005 Jul;50(7):924-9; discussion 929-31.

  PMID: 15972113 BACKGROUND

• Tomii K, Seo R, Tachikawa R, Harada Y, Murase K, Kaji R, Takeshima Y, Hayashi M, Nishimura T, Ishihara K. Impact of noninvasive ventilation (NIV) trial for various types of acute respiratory failure in the emergency department; decreased mortality and use of the ICU. Respir Med. 2009 Jan;103(1):67-73. doi: 10.1016/j.rmed.2008.08.001. Epub 2008 Sep 18.

  PMID: 18804357 BACKGROUND

• Chandra D, Stamm JA, Taylor B, Ramos RM, Satterwhite L, Krishnan JA, Mannino D, Sciurba FC, Holguin F. Outcomes of noninvasive ventilation for acute exacerbations of chronic obstructive pulmonary disease in the United States, 1998-2008. Am J Respir Crit Care Med. 2012 Jan 15;185(2):152-9. doi: 10.1164/rccm.201106-1094OC. Epub 2011 Oct 20.

  PMID: 22016446 BACKGROUND

• Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Beduneau G, Deletage-Metreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17.

  PMID: 25981908 BACKGROUND

• Brochard L, Lefebvre JC, Cordioli RL, Akoumianaki E, Richard JC. 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.

  PMID: 25111645 BACKGROUND

• Rochwerg B, Brochard L, Elliott MW, Hess D, Hill NS, Nava S, Navalesi P Members Of The Steering Committee, Antonelli M, Brozek J, Conti G, Ferrer M, Guntupalli K, Jaber S, Keenan S, Mancebo J, Mehta S, Raoof S Members Of The Task Force. Official ERS/ATS clinical practice guidelines: noninvasive ventilation for acute respiratory failure. Eur Respir J. 2017 Aug 31;50(2):1602426. doi: 10.1183/13993003.02426-2016. Print 2017 Aug.

  PMID: 28860265 BACKGROUND

• Vaschetto R, De Jong A, Conseil M, Galia F, Mahul M, Coisel Y, Prades A, Navalesi P, Jaber S. Comparative evaluation of three interfaces for non-invasive ventilation: a randomized cross-over design physiologic study on healthy volunteers. Crit Care. 2014 Jan 3;18(1):R2. doi: 10.1186/cc13175.

  PMID: 24387642 BACKGROUND

• Navalesi P, Fanfulla F, Frigerio P, Gregoretti C, Nava S. Physiologic evaluation of noninvasive mechanical ventilation delivered with three types of masks in patients with chronic hypercapnic respiratory failure. Crit Care Med. 2000 Jun;28(6):1785-90. doi: 10.1097/00003246-200006000-00015.

  PMID: 10890620 BACKGROUND

• Scala R, Accurso G, Ippolito M, Cortegiani A, Iozzo P, Vitale F, Guidelli L, Gregoretti C. Material and Technology: Back to the Future for the Choice of Interface for Non-Invasive Ventilation - A Concise Review. Respiration. 2020;99(9):800-817. doi: 10.1159/000509762. Epub 2020 Nov 18.

  PMID: 33207357 BACKGROUND

• Crimi C, Noto A, Princi P, Esquinas A, Nava S. A European survey of noninvasive ventilation practices. Eur Respir J. 2010 Aug;36(2):362-9. doi: 10.1183/09031936.00123509. Epub 2010 Jan 14.

  PMID: 20075052 BACKGROUND

• 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.

  PMID: 23263582 BACKGROUND

• Schallom M, Cracchiolo L, Falker A, Foster J, Hager J, Morehouse T, Watts P, Weems L, Kollef M. Pressure Ulcer Incidence in Patients Wearing Nasal-Oral Versus Full-Face Noninvasive Ventilation Masks. Am J Crit Care. 2015 Jul;24(4):349-56; quiz 357. doi: 10.4037/ajcc2015386.

  PMID: 26134336 BACKGROUND

• Roberts CM, Brown JL, Reinhardt AK, Kaul S, Scales K, Mikelsons C, Reid K, Winter R, Young K, Restrick L, Plant PK. Non-invasive ventilation in chronic obstructive pulmonary disease: management of acute type 2 respiratory failure. Clin Med (Lond). 2008 Oct;8(5):517-21. doi: 10.7861/clinmedicine.8-5-517.

  PMID: 18975486 BACKGROUND

• Antonelli M, Conti G, Pelosi P, Gregoretti C, Pennisi MA, Costa R, Severgnini P, Chiaranda M, Proietti R. 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.

  PMID: 11990923 BACKGROUND

• Yamaguti WP, Moderno EV, Yamashita SY, Gomes TG, Maida AL, Kondo CS, de Salles IC, de Brito CM. Treatment-related risk factors for development of skin breakdown in subjects with acute respiratory failure undergoing noninvasive ventilation or CPAP. Respir Care. 2014 Oct;59(10):1530-6. doi: 10.4187/respcare.02942. Epub 2014 Jun 3.

  PMID: 24894664 BACKGROUND

• Schettino G, Altobelli N, Kacmarek RM. 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.

  PMID: 16148468 BACKGROUND

• Conti G, Marino P, Cogliati A, Dell'Utri D, Lappa A, Rosa G, Gasparetto A. Noninvasive ventilation for the treatment of acute respiratory failure in patients with hematologic malignancies: a pilot study. Intensive Care Med. 1998 Dec;24(12):1283-8. doi: 10.1007/s001340050763.

  PMID: 9885881 BACKGROUND

• Gorecki C, Brown JM, Nelson EA, Briggs M, Schoonhoven L, Dealey C, Defloor T, Nixon J; European Quality of Life Pressure Ulcer Project group. Impact of pressure ulcers on quality of life in older patients: a systematic review. J Am Geriatr Soc. 2009 Jul;57(7):1175-83. doi: 10.1111/j.1532-5415.2009.02307.x. Epub 2009 May 21.

  PMID: 19486198 BACKGROUND

• Bennett G, Dealey C, Posnett J. The cost of pressure ulcers in the UK. Age Ageing. 2004 May;33(3):230-5. doi: 10.1093/ageing/afh086.

  PMID: 15082426 BACKGROUND

• Drew P, Posnett J, Rusling L; Wound Care Audit Team. The cost of wound care for a local population in England. Int Wound J. 2007 Jun;4(2):149-55. doi: 10.1111/j.1742-481X.2007.00337.x.

  PMID: 17651229 BACKGROUND

• 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.

  PMID: 30730303 BACKGROUND

• 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. BTS/ICS guideline for the ventilatory management of acute hypercapnic respiratory failure in adults. Thorax. 2016 Apr;71 Suppl 2:ii1-35. doi: 10.1136/thoraxjnl-2015-208209. No abstract available.

  PMID: 26976648 BACKGROUND

• 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.

  PMID: 19287920 BACKGROUND

• Cuvelier A, Pujol W, Pramil S, Molano LC, Viacroze C, Muir JF. Cephalic versus oronasal mask for noninvasive ventilation in acute hypercapnic respiratory failure. Intensive Care Med. 2009 Mar;35(3):519-26. doi: 10.1007/s00134-008-1327-x. Epub 2008 Oct 15.

  PMID: 18854973 BACKGROUND

• Ozsancak A, Sidhom SS, Liesching TN, Howard W, Hill NS. Evaluation of the total face mask for noninvasive ventilation to treat acute respiratory failure. Chest. 2011 May;139(5):1034-1041. doi: 10.1378/chest.10-1905. Epub 2011 Feb 17.

  PMID: 21330385 BACKGROUND

• Olivieri C, Costa R, Spinazzola G, Ferrone G, Longhini F, Cammarota G, Conti G, Navalesi P. Bench comparative evaluation of a new generation and standard helmet for delivering non-invasive ventilation. Intensive Care Med. 2013 Apr;39(4):734-8. doi: 10.1007/s00134-012-2765-z. Epub 2012 Dec 6.

  PMID: 23223773 BACKGROUND

• 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.

  PMID: 14695719 BACKGROUND

• Antonaglia V, Ferluga M, Molino R, Lucangelo U, Peratoner A, Roman-Pognuz E, De Simoni L, Zin WA. Comparison of noninvasive ventilation by sequential use of mask and helmet versus mask in acute exacerbation of chronic obstructive pulmonary disease: a preliminary study. Respiration. 2011;82(2):148-54. doi: 10.1159/000324259. Epub 2011 Mar 26.

  PMID: 21447934 BACKGROUND

• 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.

  PMID: 30755472 BACKGROUND

• Pisani L, Mega C, Vaschetto R, Bellone A, Scala R, Cosentini R, Musti M, Del Forno M, Grassi M, Fasano L, Navalesi P, Nava S. Oronasal mask versus helmet in acute hypercapnic respiratory failure. Eur Respir J. 2015 Mar;45(3):691-9. doi: 10.1183/09031936.00053814. Epub 2014 Dec 10.

  PMID: 25504992 BACKGROUND

• Girault C, Briel A, Benichou J, Hellot MF, Dachraoui F, Tamion F, Bonmarchand G. Interface strategy during noninvasive positive pressure ventilation for hypercapnic acute respiratory failure. Crit Care Med. 2009 Jan;37(1):124-31. doi: 10.1097/CCM.0b013e3181928706.

  PMID: 19050635 BACKGROUND

• Vaschetto R, Turucz E, Dellapiazza F, Guido S, Colombo D, Cammarota G, Della Corte F, Antonelli M, Navalesi P. Noninvasive ventilation after early extubation in patients recovering from hypoxemic acute respiratory failure: a single-centre feasibility study. Intensive Care Med. 2012 Oct;38(10):1599-606. doi: 10.1007/s00134-012-2652-7. Epub 2012 Jul 24.

  PMID: 22825283 BACKGROUND

• 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.

  PMID: 25017108 BACKGROUND

• 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.

  PMID: 30703172 BACKGROUND

• Vaschetto R, Longhini F, Persona P, Ori C, Stefani G, Liu S, Yi Y, Lu W, Yu T, Luo X, Tang R, Li M, Li J, Cammarota G, Bruni A, Garofalo E, Jin Z, Yan J, Zheng R, Yin J, Guido S, Della Corte F, Fontana T, Gregoretti C, Cortegiani A, Giarratano A, Montagnini C, Cavuto S, Qiu H, Navalesi P. Early extubation followed by immediate noninvasive ventilation vs. standard extubation in hypoxemic patients: a randomized clinical trial. Intensive Care Med. 2019 Jan;45(1):62-71. doi: 10.1007/s00134-018-5478-0. Epub 2018 Dec 10.

  PMID: 30535516 BACKGROUND

• 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.

  PMID: 17255876 BACKGROUND

• 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)

  BACKGROUND

• Brill AK. How to avoid interface problems in acute noninvasive ventilation. Breathe 2014;10:230-242

  BACKGROUND

• Vaschetto R, Gregoretti C, Scotti L, De Vita N, Carlucci A, Cortegiani A, Crimi C, Mattei A, Scala R, Rocca E, Longhini F, Cammarota G, Misseri G, Dal Molin A, Scolletta S, Nava S, Maggiore SM, Navalesi P. A pragmatic, open-label, multi-center, randomized controlled clinical trial on the rotational use of interfaces vs standard of care in patients treated with noninvasive positive pressure ventilation for acute hypercapnic respiratory failure: the ROTAtional-USE of interface STUDY (ROTA-USE STUDY). Trials. 2023 Aug 13;24(1):527. doi: 10.1186/s13063-023-07560-1.

  PMID: 37574558 DERIVED

MeSH Terms

Conditions

Pressure Ulcer; Respiratory Insufficiency

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Rosanna Vaschetto, Assoc

  Università degli Studi del Piemonte Orientale Amedeo Avogadro

  STUDY DIRECTOR

Central Study Contacts

Rosanna Vaschetto, Assoc

CONTACT

+393342724811; rosanna.vaschetto@med.uniupo.it

Nello De Vita, MD

CONTACT

+393274484990; nellodevita@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 24, 2022
• Study Start: December 8, 2022
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: November 14, 2024

Record last verified: 2024-11

Locations

IT (1)