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

Andrea Cortegiani, Egle Rondelli, Tommaso Fossali, Oriol Roca, Tomas Jovaisa, Misa Fister, Dirk Schädler, Chiara Abbruzzese, Carla Fornari, Peter Radsel, Claude Guerin, Matthieu Jabaudon, Jian-Xin Zhou, Loredana Baboi, Sara Conti, Rocco D'Andrea, Jordi Mancebo, Tommaso Mauri, Marta Lazzeri, Rosario SpinaSebastien Jochmans, César Pérez Calvo, Federico Villa, Antonio Dell'Anna, Alfio Bronco, Giacomo Grasselli, François Beloncle, Inéz Frerichs, Iole Brunetti, Roberto Rona, Savino Spadaro, Riccardo Colombo, Hodane Yonis, Lorenzo Ball, Alain Mercat, Tobias Becher, Federica Lovisari, Giuseppe Bello, Domenico Luca Grieco, Elena Spinelli, Anxela Vidal, Marina García-De-Acilu, Thomas Godet, Stefano Gianni, Irene Mori, Spiridon Karagiannis, Tomas Jovaisa, Nicolo' Patroniti, Eugenio Garofalo, Andrea Bruni, Vasiliki Zisopoulou, Davide Eleuteri, Emilia Rosas, Yu-Mei Wang, Francesco Tomeo, Sandie Mazerand, Elisabetta Maragoni, Tom Barnes, Usman Tariq, Eugenio Biamonte, Chiara Sproccati, Lorenzo Querci, Irene Mori, Silvia Villa, Alessandra Papoff, Pietro Mandelli, Riccardo Colombo, Elisabetta Maragoni, Marta Lazzeri, Tom Barnes, Irene Mori, Lorenzo Querci, Rihard Knafelj, Riccardo Pinciroli, Italo Calamai, Daniela Tubiolo, Paolo Navalesi, Norbert Weiler, Carlo Alberto Volta, Marko Noc, Giuseppe Foti, Jean-Michel Constantin, Antonio Pesenti, Paolo Pelosi, Marco Ranieri, Laurent Brochard, Ioannis Staikos, Elisabetta Pierucci

Risultato della ricerca: Article

Abstract

Background: 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).Methods: 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 cmH(2)O. 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.Discussion: 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.
Lingua originaleEnglish
Numero di pagine0
RivistaTrials
Volume19
Stato di pubblicazionePublished - 2018

All Science Journal Classification (ASJC) codes

  • Medicine (miscellaneous)
  • Pharmacology (medical)

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    Cortegiani, A., Rondelli, E., Fossali, T., Roca, O., Jovaisa, T., Fister, M., Schädler, D., Abbruzzese, C., Fornari, C., Radsel, P., Guerin, C., Jabaudon, M., Zhou, J-X., Baboi, L., Conti, S., D'Andrea, R., Mancebo, J., Mauri, T., Lazzeri, M., ... Pierucci, E. (2018). Pressure support ventilation + sigh in acute hypoxemic respiratory failure patients: Study protocol for a pilot randomized controlled trial, the PROTECTION trial. Trials, 19.