TY - JOUR
T1 - Rationale and study design of ViPS - variable pressure support for weaning from mechanical ventilation
T2 - study protocol for an international multicenter randomized controlled open trial
AU - Kiss, Thomas
AU - Gueldner, Andreas
AU - Bluth, Thomas
AU - Uhlig, Christopher
AU - Spieth, Peter Markus
AU - Markstaller, Klaus
AU - Ullrich, Roman
AU - Jaber, Samir
AU - Santos, Jose Alberto
AU - Mancebo, Jordi
AU - Camporota, Luigi
AU - Beale, Richard
AU - Schettino, Guilherme
AU - Saddy, Felipe
AU - Vallverdu, Immaculada
AU - Wiedemann, Baerbel
AU - Koch, Thea
AU - Schultz, Marcus Josephus
AU - Pelosiand, Paolo
AU - de Abreu, Marcelo Gama
PY - 2013/10/31
Y1 - 2013/10/31
N2 - 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.
AB - 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.
KW - Mechanical ventilation
KW - Weaning
KW - Pressure support ventilation
KW - Variable ventilation
KW - Intensive care unit
KW - Critical care
KW - EXPERIMENTAL LUNG INJURY
KW - VARIABILITY
KW - PNEUMONIA
KW - RISK
KW - PREDICTOR
KW - MODEL
U2 - 10.1186/1745-6215-14-363
DO - 10.1186/1745-6215-14-363
M3 - Article
SN - 1745-6215
VL - 14
JO - Trials
JF - Trials
M1 - 363
ER -