Pressure support ventilation + sigh in acute hypoxemic respiratory failure patients: study protocol for a pilot randomized controlled trial, the PROTECTION trial

Trials
Tommaso MauriProtection Study Group

Abstract

Adding cyclic short sustained inflations (sigh) to assisted ventilation yields optimizes lung recruitment, decreases heterogeneity and reduces inspiratory effort in patients with acute hypoxemic respiratory failure (AHRF). These findings suggest that adding sigh to pressure support ventilation (PSV) might decrease the risk of lung injury, shorten weaning and improve clinical outcomes. Thus, we conceived a pilot trial to test the feasibility of adding sigh to PSV (the PROTECTION study). PROTECTION is an international randomized controlled trial that will be conducted in 23 intensive care units (ICUs). Patients with AHRF who have been intubated from 24 h to 7 days and undergoing PSV from 4 to 24 h will be enrolled. All patients will first undergo a 30-min sigh test by adding sigh to clinical PSV for 30 min to identify early oxygenation responders. Then, patients will be randomized to PSV or PSV + sigh until extubation, ICU discharge, death or day 28. Sigh will be delivered as a 3-s pressure control breath delivered once per minute at 30 cmH2O. Standardized protocols will guide ventilation settings, switch back to controlled ventilation, use of rescue treatments, performance of spontaneous breathing trial, extubation and reintubat...Continue Reading

Associated Clinical Trials

References

May 1, 1970·Journal of Applied Physiology·J MeadD Leith
May 4, 2000·The New England Journal of Medicine·UNKNOWN Acute Respiratory Distress Syndrome NetworkArthur Wheeler
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Jan 25, 2011·American Journal of Respiratory and Critical Care Medicine·Giacomo BellaniAntonio Pesenti
Aug 2, 2012·The Journal of Clinical Investigation·Michael A MatthayGuy A Zimmerman
Dec 29, 2012·Respiratory Care·Richard H Kallet, Michael A Matthay
May 22, 2013·The New England Journal of Medicine·Claude GuérinUNKNOWN PROSEVA Study Group
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Aug 13, 2014·Critical Care : the Official Journal of the Critical Care Forum·Lillian MoraesPatricia Rieken Macedo Rocco
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Feb 24, 2016·JAMA : the Journal of the American Medical Association·Giacomo BellaniUNKNOWN ESICM Trials Group
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May 2, 2017·American Journal of Respiratory and Critical Care Medicine·Eddy FanUNKNOWN American Thoracic Society, European Society of Intensive Care Medicine, and Society of Critical Care Medicine
Aug 23, 2017·Annals of Translational Medicine·Tommaso MauriGiacomo Grasselli
Jan 13, 2018·American Journal of Respiratory and Critical Care Medicine·Caio C A MoraisYuji Fujino

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Methods Mentioned

BETA
sedation

Clinical Trials Mentioned

NCT03201263

Software Mentioned

SPIRIT
PROTECTION

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