Awake prone positioning in nonintubated spontaneous breathing ICU patients with acute hypoxemic respiratory failure (PRONELIFE)-protocol for a randomized clinical trial
Morales-Quinteros, Luis (Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí (I3PT))
Schultz, M. J. (University of Oxford. Nuffield Department of Medicine)
Serpa-Neto, A. (Austin Hospital and University of Melbourne. Department of Intensive Care Medicine)
Antonelli, M. (Catholic University of the Sacred Heart, "A. Gemelli" University Hospital)
Grieco, D. L. (Catholic University of the Sacred Heart, "A. Gemelli" University Hospital)
Roca, O. (Hospital Universitari Vall d'Hebron)
Juffermans, Nicole P (Onze Lieve Vrouwe Gasthuis (OLVG) Hospital. Department of Intensive Care Medicine)
de Haro, Candelaria (Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí (I3PT))
de Mendoza, Diego (Hospital del Sagrat Cor (Barcelona, Catalunya))
Blanch, Lluís (Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí (I3PT))
Camprubí-Rimblas, Marta (Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí (I3PT))
Gomà, Gemma (Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí (I3PT))
Artigas Raventós, Antoni (Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí (I3PT))
Universitat Autònoma de Barcelona. Departament de Medicina

Fecha:	2022
Resumen:	It is uncertain whether awake prone positioning can prevent intubation for invasive ventilation in spontaneous breathing critically ill patients with acute hypoxemic respiratory failure. Awake prone positioning could benefit these patients for various reasons, including a reduction in direct harm to lung tissue, and prevention of tracheal intubation-related complications. The PRONELIFE study is an investigator-initiated, international, multicenter, randomized clinical trial in patients who may need invasive ventilation because of acute hypoxemic respiratory failure. Consecutive patients admitted to participating ICUs are randomly assigned to standard care with awake prone positioning, versus standard care without awake prone positioning. The primary endpoint is a composite of tracheal intubation and all-cause mortality in the first 14 days after enrolment. Secondary endpoints include time to tracheal intubation and effects of awake prone positioning on oxygenation parameters, dyspnea sensation, and complications. Other endpoints are the number of days free from ventilation and alive at 28 days, total duration of use of noninvasive respiratory support, total duration of invasive ventilation, length of stay in ICU and hospital, and mortality in ICU and hospital, and at 28, 60, and 90 days. We will also collect data regarding the tolerance of prone positioning. The PRONELIFE study is among the first randomized clinical trials investigating the effect of awake prone positioning on intubation rate in ICU patients with acute hypoxemic failure from any cause. The PRONELIFE study is sufficiently sized to determine the effect of awake prone positioning on intubation for invasive ventilation-patients are eligible in case of acute hypoxemic respiratory failure without restrictions regarding etiology. The PRONELIFE study is a pragmatic trial in which blinding is impossible-however, as around 35 ICUs worldwide will participate in this study, its findings will be highly generalizable. The findings of the PRONELIFE study have the potential to change clinical management of patients who may need invasive ventilation because of acute hypoxemic respiratory failure. ISRCTN ISRCTN11536318. Registered on 17 September 2021. The PRONELIFE study is registered at with reference number NCT04142736 (October, 2019).
Nota:	Altres ajuts: European Society of Intensive Care Medicine
Derechos:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Lengua:	Anglès
Documento:	Article ; recerca ; Versió publicada
Materia:	ICU ; Acute respiratory failure ; Hypoxemia ; Prone position ; Awake prone positioning ; Invasive ventilation ; Intubation ; Randomized controlled trial
Publicado en:	Trials, Vol. 23 (january 2022) , ISSN 1745-6215

DOI: 10.1186/s13063-021-05991-2
PMID: 35012606

11 p, 1.1 MB

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