One-Year Follow up of Noninvasive Respiratory Support in General Wards

Moretto, Francesca; Fracazzini, Martina; Verdina, Federico; Ferrante, Daniela; Baino, Sara; Grossi, Francesca; Castello, Luigi Mario; Cammarota, Gianmaria; Balbo, Piero Emilio; Sainaghi, Pier Paolo; Campanini, Mauro; Pirisi, Mario; Patti, Giuseppe; Molin, Alberto Dal; Corte, Francesco Della; Navalesi, Paolo; Vaschetto, Rosanna

doi:10.4187/respcare.09625

Cited by 2 publications

(1 citation statement)

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“…In recent years, noninvasive ventilation (NIV) has increasingly become a common approach for the treatment of hypercapnic [ 1 , 2 ] and hypoxemic [ 3 ] patients both inside [ 3 ] and outside [ 4 – 6 ] the intensive care unit (ICU). NIV refers to the delivery of a positive pressure to the patient through interfaces like masks or helmets without the need for invasive endotracheal intubation [ 7 ].…”

Section: Introductionmentioning

confidence: 99%

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

Gregoretti

Scotti

et al. 2023

Trials

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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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