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).
Hypercapnic acute respiratory failure
Noninvasive ventilation
Pressure ulcers
Rotational use of interfaces
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
13 Aug 2023
13 Aug 2023
Historique:
received:
30
01
2023
accepted:
01
08
2023
medline:
16
8
2023
pubmed:
14
8
2023
entrez:
13
8
2023
Statut:
epublish
Résumé
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. 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. 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. ClinicalTrials.gov NCT05513508. Registered on August 24, 2022.
Sections du résumé
BACKGROUND
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
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
CONCLUSIONS
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
BACKGROUND
ClinicalTrials.gov NCT05513508. Registered on August 24, 2022.
Identifiants
pubmed: 37574558
doi: 10.1186/s13063-023-07560-1
pii: 10.1186/s13063-023-07560-1
pmc: PMC10424342
doi:
Banques de données
ClinicalTrials.gov
['NCT05513508']
Types de publication
Journal Article
Multicenter Study
Pragmatic Clinical Trial
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
527Informations de copyright
© 2023. BioMed Central Ltd., part of Springer Nature.
Références
Intensive Care Med. 2012 Oct;38(10):1599-606
pubmed: 22825283
Appl Nurs Res. 2015 Feb;28(1):36-41
pubmed: 25017108
Int Wound J. 2007 Jun;4(2):149-55
pubmed: 17651229
Intensive Care Med. 2019 Jan;45(1):62-71
pubmed: 30535516
Crit Care Med. 2002 Mar;30(3):602-8
pubmed: 11990923
Crit Care Med. 2009 Jan;37(1):124-31
pubmed: 19050635
Am J Respir Crit Care Med. 2001 Feb;163(2):540-77
pubmed: 11179136
ERJ Open Res. 2021 Jan 25;7(1):
pubmed: 33527074
Age Ageing. 2004 May;33(3):230-5
pubmed: 15082426
Respir Care. 2014 Oct;59(10):1530-6
pubmed: 24894664
Am J Crit Care. 2015 Jul;24(4):349-56; quiz 357
pubmed: 26134336
J Wound Care. 2017 Mar 2;26(3):128-136
pubmed: 28277990
Crit Care. 2014 Jan 03;18(1):R2
pubmed: 24387642
Intensive Care Med. 2002 Mar;28(3):278-84
pubmed: 11904656
Crit Care. 2021 Jun 1;25(1):189
pubmed: 34074314
Respir Care. 2005 Jul;50(7):924-9; discussion 929-31
pubmed: 15972113
Clin Med (Lond). 2008 Oct;8(5):517-21
pubmed: 18975486
Eur Respir J. 2010 Aug;36(2):362-9
pubmed: 20075052
CMAJ. 2014 Feb 18;186(3):E112-22
pubmed: 24324020
Thorax. 2016 Apr;71 Suppl 2:ii1-35
pubmed: 26976648
Crit Care Med. 2000 Jun;28(6):1785-90
pubmed: 10890620
Crit Care Med. 2005 Sep;33(9):1976-82
pubmed: 16148468
Semin Respir Crit Care Med. 2014 Aug;35(4):492-500
pubmed: 25111645
Intensive Care Med. 1998 Dec;24(12):1283-8
pubmed: 9885881
Respir Care. 2022 Jul 19;:
pubmed: 35853702
N Engl J Med. 2015 Jun 4;372(23):2185-96
pubmed: 25981908
Chest. 2011 May;139(5):1034-1041
pubmed: 21330385
Respir Care. 2015 Apr;60(4):586-92
pubmed: 25406347
Minerva Anestesiol. 2009 Jan-Feb;75(1-2):31-6
pubmed: 18421257
J Am Geriatr Soc. 2009 Jul;57(7):1175-83
pubmed: 19486198
Am J Respir Crit Care Med. 2012 Jan 15;185(2):152-9
pubmed: 22016446
Eur Respir J. 2017 Aug 31;50(2):
pubmed: 28860265
Respir Med. 2009 Jan;103(1):67-73
pubmed: 18804357
PLoS One. 2019 Jan 31;14(1):e0211476
pubmed: 30703172
Crit Care Med. 2007 Mar;35(3):932-9
pubmed: 17255876
Anesth Analg. 2009 Jul;109(1):164-7
pubmed: 19439687
Respiration. 2020;99(9):800-817
pubmed: 33207357