THE ViPS TRIAL

Variable Pressure Support Ventilation

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Pulmonary Engineering Group

200:SProtocol:Objectives

Objectives

Primary objective of the trial

The primary objective is to test whether variable as compared to non-variable (conventional) PSV reduces the duration of mechanical ventilation.

Secondary objectives of the trial

The secondary objectives are to test whether variable as compared to non-variable pressure sup-port ventilation:

  • shortens the total time of mechanical ventilation,
  • shortens length of stay in the ICU and in-hospital
  • reduces mortality
  • improves lung function
  • improves patient comfort;
  • reduces organ failure
  • reduces the need for noninvasive ventilation and reintubation;
  • reduces the number of interventions of the ICU personal in the mechanical ventilator;
  • increases the variability of respiratory parameters of the breathing pattern

Primary endpoint of the trial

Primary Endpoint: Weaning time defined as time of randomization to successful extubation.

Secondary endpoints of the trial

Secondary Endpoints

  • Total time of mechanical ventilation
  • Time from randomization to first extubation
  • Time from randomization to fulfillment of extubation criteria
  • Time between fulfillment of extubation criteria and extubation
  • ICU length of stay, in-hospital length of stay
  • ICU and in-hospital-mortality, mortality at day 90 and 6 month
  • PaO2/FIO2, PaCO2
  • Minute ventilation
  • Mean tidal volume ( VT), mean pressure support, mean airway pressure, mean peak inspiratory pressure
  • Inspiratory airway occlusion pressure at 100 ms (P0.1)
  • Visual analogue scale for breathing comfort
  • Cumulative amount of sedative and analgesic drugs
  • SOFA-Score
  • Incidence of reintubation
  • Incidence of noninvasive ventilation (NIV)
  • Postextubation length of NIV
  • Ventilator-free-days (28-days)
  • Number of changes in mean pressure support by ICU personnel
  • Coefficients of variation of VT, pressure support, respiratory rate, inspiratory and expiratory times
200/SProtocol/Objectives.txt · Last modified: 2014/04/07 22:50 (external edit)

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