Awake prone positioning in nonintubated spontaneous breathing ICU patients with acute hypoxemic respiratory failure (PRONELIFE)—protocol for a randomized clinical trial

Trials

for the PRONELIFE collaborative group¹  M. Antonelli²  D. L. Grieco²  N. P. Juffermans³  M. J. Schultz³  A. Serpa-Neto³  O. Roca⁴  Gemma Gomà⁵  L. Morales-Quinteros⁶  D. de Mendoza⁷  A. Artigas-Raventós⁸  Ll. Blanch⁸  C. de Haro⁸  M. Camprubí-Rimblas⁸ 

[1] ;Department of Anesthesiology and Intensive Care Medicine, Catholic University of the Sacred Heart, “A. Gemelli” University Hospital;Department of Intensive & Laboratory of Experimental Intensive Care and Anesthesiology, Amsterdam UMC, location “AMC”;Department of Intensive Care Medicine & Vall d’Hebron Research Institute, Vall d’Hebron University Hospital, Universitat Autònoma de Barcelona;Department of Intensive Care Medicine, Corporación Sanitaria Universitaria Parc Tauli;Department of Intensive Care Medicine, Hospital Universitari Sant Pau;Department of Intensive Care Medicine, Sagrat Cor University Hospital, Grupo Quironsalud;Translational Research Laboratory, Institut d’Investigació i Innovació Parc Taulí I3PT Universitat Autònoma de Barcelona Sabadell;

关键词: ICU;    Acute respiratory failure;    Hypoxemia;    Prone position;    Awake prone positioning;    Invasive ventilation;   

DOI  :  10.1186/s13063-021-05991-2

来源: DOAJ

【 摘 要 】

Abstract Background 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. Design and methods 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. Discussion 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. Trial registration ISRCTN ISRCTN11536318 . Registered on 17 September 2021. The PRONELIFE study is registered at clinicaltrials.gov with reference number NCT04142736 (October, 2019).

【 授权许可】

Unknown