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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)

BACKGROUND: In the last decades, noninvasive ventilation (NIV) has been increasingly used to support patients with hypercapnic and hypoxemic acute respiratory failure. Pressure ulcers are a frequently observed NIV-related adverse effect, directly related to interface type and exposure time. Switchin...

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Autores principales: Vaschetto, Rosanna, Gregoretti, Cesare, Scotti, Lorenza, De Vita, Nello, Carlucci, Annalisa, Cortegiani, Andrea, Crimi, Claudia, Mattei, Alessio, Scala, Raffaele, Rocca, Eduardo, Longhini, Federico, Cammarota, Gianmaria, Misseri, Giovanni, Dal Molin, Alberto, Scolletta, Sabino, Nava, Stefano, Maggiore, Salvatore Maurizio, Navalesi, Paolo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10424342/
https://www.ncbi.nlm.nih.gov/pubmed/37574558
http://dx.doi.org/10.1186/s13063-023-07560-1
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author Vaschetto, Rosanna
Gregoretti, Cesare
Scotti, Lorenza
De Vita, Nello
Carlucci, Annalisa
Cortegiani, Andrea
Crimi, Claudia
Mattei, Alessio
Scala, Raffaele
Rocca, Eduardo
Longhini, Federico
Cammarota, Gianmaria
Misseri, Giovanni
Dal Molin, Alberto
Scolletta, Sabino
Nava, Stefano
Maggiore, Salvatore Maurizio
Navalesi, Paolo
author_facet Vaschetto, Rosanna
Gregoretti, Cesare
Scotti, Lorenza
De Vita, Nello
Carlucci, Annalisa
Cortegiani, Andrea
Crimi, Claudia
Mattei, Alessio
Scala, Raffaele
Rocca, Eduardo
Longhini, Federico
Cammarota, Gianmaria
Misseri, Giovanni
Dal Molin, Alberto
Scolletta, Sabino
Nava, Stefano
Maggiore, Salvatore Maurizio
Navalesi, Paolo
author_sort Vaschetto, Rosanna
collection PubMed
description BACKGROUND: In the last decades, noninvasive ventilation (NIV) has been increasingly used to support patients with hypercapnic and hypoxemic acute respiratory failure. Pressure ulcers are a frequently observed NIV-related adverse effect, directly related to interface type and exposure time. Switching to a different interface has been proposed as a solution to improve patient comfort. However, large studies investigating the benefit of this strategy are not available. Thus, the aim of the ROTAtional-USE of interface STUDY (ROTA-USE STUDY) is to investigate whether a protocolized rotational use of interfaces during NIV is effective in reducing the incidence of pressure ulcers. METHODS: The ROTA-USE STUDY is a pragmatic, parallel arm, open-label, multicenter, spontaneous, non-profit, randomized controlled trial requiring non-significant risk medical devices, with the aim to determine whether a rotational strategy of NIV interfaces is associated with a lower incidence of pressure ulcers compared to the standard of care. In the intervention group, NIV mask will be randomly chosen and rotated every 6 h. In the control group, mask will be chosen according to the standard of care of the participating centers and changed in case of discomfort or in the presence of new pressure sores. In both groups, the skin underneath the mask will be inspected every 12 h for any possible damage by blinded assessors. The primary outcome is the proportion of patients developing new pressure sores at 36 h from randomization. The secondary outcomes are (i) onset of pressure sores measured at different time points, i.e., 12, 24, 36, 48, 60, 72, 84, and 96 h; (ii) number and stage of pressure sores and comfort measured at 12, 24, 36, 48, 60, 72, 84, and 96 h; and (iii) the economic impact of the protocolized rotational use of interfaces. A sample size of 239 subjects per group (intervention and control) is estimated to detect a 10% absolute difference in the proportion of patients developing pressure sores at 36 h. DISCUSSION: The development of pressure ulcers is a common side effect of NIV that negatively affects the patients’ comfort and tolerance, often leading to NIV failure and adverse outcomes. The ROTA-USE STUDY will determine whether a protocolized rotational approach can reduce the incidence, number, and severity of pressure ulcers in NIV-treated patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT05513508. Registered on August 24, 2022.
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spelling pubmed-104243422023-08-15 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) Vaschetto, Rosanna Gregoretti, Cesare Scotti, Lorenza De Vita, Nello Carlucci, Annalisa Cortegiani, Andrea Crimi, Claudia Mattei, Alessio Scala, Raffaele Rocca, Eduardo Longhini, Federico Cammarota, Gianmaria Misseri, Giovanni Dal Molin, Alberto Scolletta, Sabino Nava, Stefano Maggiore, Salvatore Maurizio Navalesi, Paolo Trials Study Protocol BACKGROUND: In the last decades, noninvasive ventilation (NIV) has been increasingly used to support patients with hypercapnic and hypoxemic acute respiratory failure. Pressure ulcers are a frequently observed NIV-related adverse effect, directly related to interface type and exposure time. Switching to a different interface has been proposed as a solution to improve patient comfort. However, large studies investigating the benefit of this strategy are not available. Thus, the aim of the ROTAtional-USE of interface STUDY (ROTA-USE STUDY) is to investigate whether a protocolized rotational use of interfaces during NIV is effective in reducing the incidence of pressure ulcers. METHODS: The ROTA-USE STUDY is a pragmatic, parallel arm, open-label, multicenter, spontaneous, non-profit, randomized controlled trial requiring non-significant risk medical devices, with the aim to determine whether a rotational strategy of NIV interfaces is associated with a lower incidence of pressure ulcers compared to the standard of care. In the intervention group, NIV mask will be randomly chosen and rotated every 6 h. In the control group, mask will be chosen according to the standard of care of the participating centers and changed in case of discomfort or in the presence of new pressure sores. In both groups, the skin underneath the mask will be inspected every 12 h for any possible damage by blinded assessors. The primary outcome is the proportion of patients developing new pressure sores at 36 h from randomization. The secondary outcomes are (i) onset of pressure sores measured at different time points, i.e., 12, 24, 36, 48, 60, 72, 84, and 96 h; (ii) number and stage of pressure sores and comfort measured at 12, 24, 36, 48, 60, 72, 84, and 96 h; and (iii) the economic impact of the protocolized rotational use of interfaces. A sample size of 239 subjects per group (intervention and control) is estimated to detect a 10% absolute difference in the proportion of patients developing pressure sores at 36 h. DISCUSSION: The development of pressure ulcers is a common side effect of NIV that negatively affects the patients’ comfort and tolerance, often leading to NIV failure and adverse outcomes. The ROTA-USE STUDY will determine whether a protocolized rotational approach can reduce the incidence, number, and severity of pressure ulcers in NIV-treated patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT05513508. Registered on August 24, 2022. BioMed Central 2023-08-13 /pmc/articles/PMC10424342/ /pubmed/37574558 http://dx.doi.org/10.1186/s13063-023-07560-1 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Vaschetto, Rosanna
Gregoretti, Cesare
Scotti, Lorenza
De Vita, Nello
Carlucci, Annalisa
Cortegiani, Andrea
Crimi, Claudia
Mattei, Alessio
Scala, Raffaele
Rocca, Eduardo
Longhini, Federico
Cammarota, Gianmaria
Misseri, Giovanni
Dal Molin, Alberto
Scolletta, Sabino
Nava, Stefano
Maggiore, Salvatore Maurizio
Navalesi, Paolo
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)
title 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)
title_full 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)
title_fullStr 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)
title_full_unstemmed 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)
title_short 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)
title_sort 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)
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10424342/
https://www.ncbi.nlm.nih.gov/pubmed/37574558
http://dx.doi.org/10.1186/s13063-023-07560-1
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