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Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

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

Authors: Tommaso Mauri, Giuseppe Foti, Carla Fornari, Jean-Michel Constantin, Claude Guerin, Paolo Pelosi, Marco Ranieri, Sara Conti, Daniela Tubiolo, Egle Rondelli, Federica Lovisari, Tommaso Fossali, Savino Spadaro, Domenico Luca Grieco, Paolo Navalesi, Italo Calamai, Tobias Becher, Oriol Roca, Yu-Mei Wang, Rihard Knafelj, Andrea Cortegiani, Jordi Mancebo, Laurent Brochard, Antonio Pesenti, for the Protection Study Group

Published in: Trials | Issue 1/2018

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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 cmH2O. 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.

Trial registration

ClinicalTrials.gov, NCT03201263. Registered on 28 June 2017.
Appendix
Available only for authorised users
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Metadata
Title
Pressure support ventilation + sigh in acute hypoxemic respiratory failure patients: study protocol for a pilot randomized controlled trial, the PROTECTION trial
Authors
Tommaso Mauri
Giuseppe Foti
Carla Fornari
Jean-Michel Constantin
Claude Guerin
Paolo Pelosi
Marco Ranieri
Sara Conti
Daniela Tubiolo
Egle Rondelli
Federica Lovisari
Tommaso Fossali
Savino Spadaro
Domenico Luca Grieco
Paolo Navalesi
Italo Calamai
Tobias Becher
Oriol Roca
Yu-Mei Wang
Rihard Knafelj
Andrea Cortegiani
Jordi Mancebo
Laurent Brochard
Antonio Pesenti
for the Protection Study Group
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2828-8

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