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

Thomas Kiss, Andreas Güldner, Thomas Bluth, Christopher Uhlig, Peter Markus Spieth, Klaus Markstaller, Roman Ullrich, Samir Jaber, Jose Alberto Santos, Jordi Mancebo, Luigi Camporota, Richard Beale, Guilherme Schettino, Felipe Saddy, Immaculada Vallverdú, Bärbel Wiedemann, Thea Koch, Marcus Josephus Schultz, Paolo Pelosi, Marcelo Gama de Abreu, Thomas Kiss, Andreas Güldner, Thomas Bluth, Christopher Uhlig, Peter Markus Spieth, Klaus Markstaller, Roman Ullrich, Samir Jaber, Jose Alberto Santos, Jordi Mancebo, Luigi Camporota, Richard Beale, Guilherme Schettino, Felipe Saddy, Immaculada Vallverdú, Bärbel Wiedemann, Thea Koch, Marcus Josephus Schultz, Paolo Pelosi, Marcelo Gama de Abreu

Abstract

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.

Figures

Figure 1
Figure 1
CONSORT diagram of the trial.Psupp is the level of pressure support.

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