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Pressure support ventilation + sigh in acute hypoxemic respiratory failure patients: study protocol for a pilot randomized controlled trial, the PROTECTION trial
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 venti...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6114230/ https://www.ncbi.nlm.nih.gov/pubmed/30157955 http://dx.doi.org/10.1186/s13063-018-2828-8 |
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author | Mauri, Tommaso Foti, Giuseppe Fornari, Carla Constantin, Jean-Michel Guerin, Claude Pelosi, Paolo Ranieri, Marco Conti, Sara Tubiolo, Daniela Rondelli, Egle Lovisari, Federica Fossali, Tommaso Spadaro, Savino Grieco, Domenico Luca Navalesi, Paolo Calamai, Italo Becher, Tobias Roca, Oriol Wang, Yu-Mei Knafelj, Rihard Cortegiani, Andrea Mancebo, Jordi Brochard, Laurent Pesenti, Antonio |
author_facet | Mauri, Tommaso Foti, Giuseppe Fornari, Carla Constantin, Jean-Michel Guerin, Claude Pelosi, Paolo Ranieri, Marco Conti, Sara Tubiolo, Daniela Rondelli, Egle Lovisari, Federica Fossali, Tommaso Spadaro, Savino Grieco, Domenico Luca Navalesi, Paolo Calamai, Italo Becher, Tobias Roca, Oriol Wang, Yu-Mei Knafelj, Rihard Cortegiani, Andrea Mancebo, Jordi Brochard, Laurent Pesenti, Antonio |
author_sort | Mauri, Tommaso |
collection | PubMed |
description | 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. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03201263. Registered on 28 June 2017. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-018-2828-8) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-6114230 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-61142302018-09-04 Pressure support ventilation + sigh in acute hypoxemic respiratory failure patients: study protocol for a pilot randomized controlled trial, the PROTECTION trial Mauri, Tommaso Foti, Giuseppe Fornari, Carla Constantin, Jean-Michel Guerin, Claude Pelosi, Paolo Ranieri, Marco Conti, Sara Tubiolo, Daniela Rondelli, Egle Lovisari, Federica Fossali, Tommaso Spadaro, Savino Grieco, Domenico Luca Navalesi, Paolo Calamai, Italo Becher, Tobias Roca, Oriol Wang, Yu-Mei Knafelj, Rihard Cortegiani, Andrea Mancebo, Jordi Brochard, Laurent Pesenti, Antonio Trials Study Protocol 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. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03201263. Registered on 28 June 2017. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-018-2828-8) contains supplementary material, which is available to authorized users. BioMed Central 2018-08-29 /pmc/articles/PMC6114230/ /pubmed/30157955 http://dx.doi.org/10.1186/s13063-018-2828-8 Text en © The Author(s). 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Study Protocol Mauri, Tommaso Foti, Giuseppe Fornari, Carla Constantin, Jean-Michel Guerin, Claude Pelosi, Paolo Ranieri, Marco Conti, Sara Tubiolo, Daniela Rondelli, Egle Lovisari, Federica Fossali, Tommaso Spadaro, Savino Grieco, Domenico Luca Navalesi, Paolo Calamai, Italo Becher, Tobias Roca, Oriol Wang, Yu-Mei Knafelj, Rihard Cortegiani, Andrea Mancebo, Jordi Brochard, Laurent Pesenti, Antonio Pressure support ventilation + sigh in acute hypoxemic respiratory failure patients: study protocol for a pilot randomized controlled trial, the PROTECTION trial |
title | Pressure support ventilation + sigh in acute hypoxemic respiratory failure patients: study protocol for a pilot randomized controlled trial, the PROTECTION trial |
title_full | Pressure support ventilation + sigh in acute hypoxemic respiratory failure patients: study protocol for a pilot randomized controlled trial, the PROTECTION trial |
title_fullStr | Pressure support ventilation + sigh in acute hypoxemic respiratory failure patients: study protocol for a pilot randomized controlled trial, the PROTECTION trial |
title_full_unstemmed | Pressure support ventilation + sigh in acute hypoxemic respiratory failure patients: study protocol for a pilot randomized controlled trial, the PROTECTION trial |
title_short | Pressure support ventilation + sigh in acute hypoxemic respiratory failure patients: study protocol for a pilot randomized controlled trial, the PROTECTION trial |
title_sort | pressure support ventilation + sigh in acute hypoxemic respiratory failure patients: study protocol for a pilot randomized controlled trial, the protection trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6114230/ https://www.ncbi.nlm.nih.gov/pubmed/30157955 http://dx.doi.org/10.1186/s13063-018-2828-8 |
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