Pressure support ventilation + sigh in acute hypoxemic respiratory failure patients : study protocol for a pilot randomized controlled trial, the PROTECTION trial
Mauri, Tommaso (University of Milan)
Foti, Giuseppe (University of Milan-Bicocca)
Fornari, Carla (University of Milan-Bicocca)
Constantin, Jean-Michel (University Hospital of Clermont-Ferrand)
Guerin, Claude (Hôpital de la Croix Rousse)
Pelosi, Paolo (San Martino Policlinico Hospital)
Ranieri, Marco (Sapienza University of Rome)
Conti, Sara (University of Milan-Bicocca)
Tubiolo, Daniela (University of Milan)
Rondelli, Egle (University of Milan-Bicocca)
Lovisari, Federica (University of Milan-Bicocca, Milan, Italy)
Fossali, Tommaso (ASST Fatebenefratelli Sacco - Luigi Sacco Hospital)
Spadaro, Savino (Azienda Ospedaliera-Universitaria Arcispedale Sant'Anna)
Grieco, Domenico Luca (Catholic University of The Sacred Heart, IRCCS Fondazione Policlinico A. Gemelli)
Navalesi, Paolo (Università Magna Graecia di Catanzaro)
Calamai, Italo (San Giuseppe Hospital. AUSL Toscana Centro)
Becher, Tobias (University Medical Center Schleswig-Holstein)
Roca, Oriol (Hospital Universitari Vall d'Hebron)
Wang, Yu-Mei (Beijing Tiantan Hospital, Capital Medical University)
Knafelj, Rihard (University Medical Center Ljubljana)
Cortegiani, Andrea (University of Palermo)
Mancebo, Jordi (Jordi) (Universitat Autònoma de Barcelona. Departament de Medicina)
Brochard, Laurent (St. Michael's Hospital. Keenan Research Centre, Li Ka Shing Knowledge Institute)
Pesenti, Antonio (Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico)
Universitat Autònoma de Barcelona

Date:	2018
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 cmHO. Standardized protocols will guide ventilation settings, switch back to controlled ventilation, use of rescue treatments, performance of spontaneous breathing trial, extubation and reintubation. The primary endpoint of the study will be to verify the feasibility of PSV + sigh evaluated through reduction of failure to remain on assisted ventilation during the first 28 days in the PSV + sigh group versus standard PSV (15 vs. 22%). Failure will be defined by switch back to controlled ventilation for more than 24 h or use of rescue treatments or reintubation within 48 h from elective extubation. Setting the power to 80% and first-risk order to 5%, the computed size of the trial is 129 patients per arm. PROTECTION is a pilot randomized controlled trial testing the feasibility of adding sigh to PSV. If positive, it will provide physicians with an effective addition to standard PSV for lung protection, able to reduce failure of assisted ventilation. PROTECTION will provide the basis for a future larger trial aimed at verifying the impact of PSV + sigh on 28-day survival and ventilator-free days. ClinicalTrials. gov, . Registered on 28 June 2017. The online version of this article (10. 1186/s13063-018-2828-8) contains supplementary material, which is available to authorized users.
Rights:	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.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Mechanical ventilation ; Intervention study ; Ventilator-induced lung injury ; Positive-pressure ventilation ; Sigh ; Recruitment ; Weaning ; Pressure support
Published in:	Trials, Vol. 19 (august 2018) , ISSN 1745-6215

DOI: 10.1186/s13063-018-2828-8
PMID: 30157955

10 p, 1.1 MB

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Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut de Recerca Sant Pau
Articles > Research articles
Articles > Published articles