High flow nasal catheter therapy versus non-invasive positive pressure ventilation in acute respiratory failure (RENOVATE trial): protocol and statistical analysis plan

Investigators and the BRICNet Up to 49% of intensive care unit (ICU) admissions are due to acute respiratory failure (ARF). 1 Respiratory support may be provided through invasive or noninvasive ventilation.The incidence of ARF demanding invasive mechanical ventilation has been reported to be 137 hospitalisations per 100 000 population older than 5 years of age, with 36-48% mortality. 1,2voiding unnecessary invasive mechanical ventilation is important because this type of respiratory support is not exempt from complications.[3][4][5][6] High flow nasal catheter (HFNC) therapy and noninvasive positive pressure ventilation (NIPPV) are used for respiratory support in patients with ARF.HFNC therapy is a newer method of initial respiratory support which enables delivery of continuous high gas flow (up to 70 L/min) via nasal prongs, high fraction of inspired oxygen (Fio 2 ) and some positive end-expiratory pressure (PEEP).7,8 NIPPV has been used to avoid intubation at ICU arrival in 20% of ARF patients overall. 9By delivering positive pressure during respiration, NIPPV increases functional residual capacity and opens collapsed alveoli, which contributes to increasing ventilation and decreasing intrapulmonary shunting.Furthermore, it improves lung compliance, decreases the work of breathing, reduces afterload and increases cardiac output, so it contributes to improved oxygenation.10,11 HFNC therapy acts through different mechanisms.It improves oxygenation, providing stable alveolar Fio 2 ; it increases carbon dioxide clearance, decreasing anatomic dead space; it reduces the work of breathing and the respiratory rate; and it increases pharyngeal pressure and lung volume, contributing to a PEEP effect (although less remarkable compared with NIPPV).Moreover, lung stress and strain are decreased, and patient comfort is improved, allowing patients to eat, drink and talk without therapy interruption.8,[12][13][14][15][16][17] Heterogeneity is also present in the pathophysiology of different aetiologies of ARF.For hypoxaemic ARF, acute lung injury promotes increased pulmonary ABSTRACT Background: The best way to offer non-invasive respiratory support across several aetiologies of acute respiratory failure (ARF) is presently unclear.Both high flow nasal catheter (HFNC) therapy and non-invasive positive pressure ventilation (NIPPV) may improve outcomes in critically ill patients by avoiding the need for invasive mechanical ventilation (IMV).Objective: Describe the details of the protocol and statistical analysis plan designed to test whether HFNC therapy is noninferior or even superior to NIPPV in patients with ARF due to different aetiologies.Methods: RENOVATE is a multicentre adaptive randomised controlled trial that is recruiting patients from adult emergency departments, wards and intensive care units (ICUs).It takes advantage of an adaptive Bayesian framework to assess the effectiveness of HFNC therapy versus NIPPV in four subgroups of ARF (hypoxaemic non-immunocompromised, hypoxaemic immunocompromised, chronic obstructive pulmonary disease exacerbations, and acute cardiogenic pulmonary oedema).The study will report the posterior probabilities of non-inferiority, superiority or futility for the comparison between HFNC therapy and NIPPV.The study assumes neutral priors and the final sample size is not fixed.The final sample size will be determined by a priori determined stopping rules for non-inferiority, superiority and futility for each subgroup or by reaching the maximum of 2000 patients.Outcomes: The primary endpoint is endotracheal intubation or death within 7 days.Secondary outcomes are 28-day and 90-day mortality, and ICU-free and IMV-free days in the first 28 days.Results and conclusions: RENOVATE is designed to provide evidence on whether HFNC therapy improves, compared with NIPPV, important patient-centred outcomes in different aetiologies of ARF.Here, we describe the rationale, design and status of the trial.

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