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Rationale and study design of ViPS – variable pressure support for weaning from mechanical ventilation: study protocol for an international multicenter randomized controlled open trial

BACKGROUND: In pressure support ventilation (PSV), a non-variable level of pressure support is delivered by the ventilator when triggered by the patient. In contrast, variable PSV delivers a level of pressure support that varies in a random fashion, introducing more physiological variability to the...

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Autores principales: Kiss, Thomas, Güldner, Andreas, Bluth, Thomas, Uhlig, Christopher, Spieth, Peter Markus, Markstaller, Klaus, Ullrich, Roman, Jaber, Samir, Santos, Jose Alberto, Mancebo, Jordi, Camporota, Luigi, Beale, Richard, Schettino, Guilherme, Saddy, Felipe, Vallverdú, Immaculada, Wiedemann, Bärbel, Koch, Thea, Schultz, Marcus Josephus, Pelosi, Paolo, de Abreu, Marcelo Gama
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3827000/
https://www.ncbi.nlm.nih.gov/pubmed/24176188
http://dx.doi.org/10.1186/1745-6215-14-363
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author Kiss, Thomas
Güldner, Andreas
Bluth, Thomas
Uhlig, Christopher
Spieth, Peter Markus
Markstaller, Klaus
Ullrich, Roman
Jaber, Samir
Santos, Jose Alberto
Mancebo, Jordi
Camporota, Luigi
Beale, Richard
Schettino, Guilherme
Saddy, Felipe
Vallverdú, Immaculada
Wiedemann, Bärbel
Koch, Thea
Schultz, Marcus Josephus
Pelosi, Paolo
de Abreu, Marcelo Gama
author_facet Kiss, Thomas
Güldner, Andreas
Bluth, Thomas
Uhlig, Christopher
Spieth, Peter Markus
Markstaller, Klaus
Ullrich, Roman
Jaber, Samir
Santos, Jose Alberto
Mancebo, Jordi
Camporota, Luigi
Beale, Richard
Schettino, Guilherme
Saddy, Felipe
Vallverdú, Immaculada
Wiedemann, Bärbel
Koch, Thea
Schultz, Marcus Josephus
Pelosi, Paolo
de Abreu, Marcelo Gama
author_sort Kiss, Thomas
collection PubMed
description BACKGROUND: In pressure support ventilation (PSV), a non-variable level of pressure support is delivered by the ventilator when triggered by the patient. In contrast, variable PSV delivers a level of pressure support that varies in a random fashion, introducing more physiological variability to the respiratory pattern. Experimental studies show that variable PSV improves gas exchange, reduces lung inflammation and the mean pressure support, compared to non-variable PSV. Thus, it can theoretically shorten weaning from the mechanical ventilator. METHODS/DESIGN: The ViPS (variable pressure support) trial is an international investigator-initiated multicenter randomized controlled open trial comparing variable vs. non-variable PSV. Adult patients on controlled mechanical ventilation for more than 24 hours who are ready to be weaned are eligible for the study. The randomization sequence is blocked per center and performed using a web-based platform. Patients are randomly assigned to one of the two groups: variable PSV or non-variable PSV. In non-variable PSV, breath-by-breath pressure support is kept constant and targeted to achieve a tidal volume of 6 to 8 ml/kg. In variable PSV, the mean pressure support level over a specific time period is targeted at the same mean tidal volume as non-variable PSV, but individual levels vary randomly breath-by-breath. The primary endpoint of the trial is the time to successful weaning, defined as the time from randomization to successful extubation. DISCUSSION: ViPS is the first randomized controlled trial investigating whether variable, compared to non-variable PSV, shortens the duration of weaning from mechanical ventilation in a mixed population of critically ill patients. This trial aims to determine the role of variable PSV in the intensive care unit. TRIAL REGISTRATION: clinicaltrials.gov NCT01769053
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spelling pubmed-38270002013-11-14 Rationale and study design of ViPS – variable pressure support for weaning from mechanical ventilation: study protocol for an international multicenter randomized controlled open trial Kiss, Thomas Güldner, Andreas Bluth, Thomas Uhlig, Christopher Spieth, Peter Markus Markstaller, Klaus Ullrich, Roman Jaber, Samir Santos, Jose Alberto Mancebo, Jordi Camporota, Luigi Beale, Richard Schettino, Guilherme Saddy, Felipe Vallverdú, Immaculada Wiedemann, Bärbel Koch, Thea Schultz, Marcus Josephus Pelosi, Paolo de Abreu, Marcelo Gama Trials Study Protocol BACKGROUND: In pressure support ventilation (PSV), a non-variable level of pressure support is delivered by the ventilator when triggered by the patient. In contrast, variable PSV delivers a level of pressure support that varies in a random fashion, introducing more physiological variability to the respiratory pattern. Experimental studies show that variable PSV improves gas exchange, reduces lung inflammation and the mean pressure support, compared to non-variable PSV. Thus, it can theoretically shorten weaning from the mechanical ventilator. METHODS/DESIGN: The ViPS (variable pressure support) trial is an international investigator-initiated multicenter randomized controlled open trial comparing variable vs. non-variable PSV. Adult patients on controlled mechanical ventilation for more than 24 hours who are ready to be weaned are eligible for the study. The randomization sequence is blocked per center and performed using a web-based platform. Patients are randomly assigned to one of the two groups: variable PSV or non-variable PSV. In non-variable PSV, breath-by-breath pressure support is kept constant and targeted to achieve a tidal volume of 6 to 8 ml/kg. In variable PSV, the mean pressure support level over a specific time period is targeted at the same mean tidal volume as non-variable PSV, but individual levels vary randomly breath-by-breath. The primary endpoint of the trial is the time to successful weaning, defined as the time from randomization to successful extubation. DISCUSSION: ViPS is the first randomized controlled trial investigating whether variable, compared to non-variable PSV, shortens the duration of weaning from mechanical ventilation in a mixed population of critically ill patients. This trial aims to determine the role of variable PSV in the intensive care unit. TRIAL REGISTRATION: clinicaltrials.gov NCT01769053 BioMed Central 2013-10-31 /pmc/articles/PMC3827000/ /pubmed/24176188 http://dx.doi.org/10.1186/1745-6215-14-363 Text en Copyright © 2013 Kiss et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Study Protocol
Kiss, Thomas
Güldner, Andreas
Bluth, Thomas
Uhlig, Christopher
Spieth, Peter Markus
Markstaller, Klaus
Ullrich, Roman
Jaber, Samir
Santos, Jose Alberto
Mancebo, Jordi
Camporota, Luigi
Beale, Richard
Schettino, Guilherme
Saddy, Felipe
Vallverdú, Immaculada
Wiedemann, Bärbel
Koch, Thea
Schultz, Marcus Josephus
Pelosi, Paolo
de Abreu, Marcelo Gama
Rationale and study design of ViPS – variable pressure support for weaning from mechanical ventilation: study protocol for an international multicenter randomized controlled open trial
title Rationale and study design of ViPS – variable pressure support for weaning from mechanical ventilation: study protocol for an international multicenter randomized controlled open trial
title_full Rationale and study design of ViPS – variable pressure support for weaning from mechanical ventilation: study protocol for an international multicenter randomized controlled open trial
title_fullStr Rationale and study design of ViPS – variable pressure support for weaning from mechanical ventilation: study protocol for an international multicenter randomized controlled open trial
title_full_unstemmed Rationale and study design of ViPS – variable pressure support for weaning from mechanical ventilation: study protocol for an international multicenter randomized controlled open trial
title_short Rationale and study design of ViPS – variable pressure support for weaning from mechanical ventilation: study protocol for an international multicenter randomized controlled open trial
title_sort rationale and study design of vips – variable pressure support for weaning from mechanical ventilation: study protocol for an international multicenter randomized controlled open trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3827000/
https://www.ncbi.nlm.nih.gov/pubmed/24176188
http://dx.doi.org/10.1186/1745-6215-14-363
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