Study of a Strategy to Prevent Oversedation in Intensive Care Patients Under Mechanical Ventilation (AWARE)

• Day-90 mortality [ Time Frame: Mortality at Day 90 after randomization ] [ Designated as safety issue: No ]
  

• Mortality at Day 28 [ Time Frame: at day 28 ] [ Designated as safety issue: No ]
  
• Hospital mortality [ Time Frame: at hospital discharge, up to day 90 ] [ Designated as safety issue: No ]
  
• 1-yr mortality [ Time Frame: at 1 yr ] [ Designated as safety issue: No ]
  
• Mechanical ventilation duration [ Time Frame: From onset of mechanical ventilation to day 28 ] [ Designated as safety issue: No ]
  
• Days alive with no mechanical ventilation [ Time Frame: From ICU admission up to day 28 ] [ Designated as safety issue: No ]
  
• Occurence of ventilator-associated pneumonia [ Time Frame: During mechanical ventilation duration, up to day 28 ] [ Designated as safety issue: No ]
  
• Use of non-invasive ventilation after extubation [ Time Frame: From extubation to ICU discharge up to day 28 ] [ Designated as safety issue: No ]
  
• Duration of ICU stay [ Time Frame: From ICU admission to ICU discharge or death in ICU, up to day 90 ] [ Designated as safety issue: No ]
  
• ICU confusion [ Time Frame: From Day 1 to 7, and at day 14, 21 and 28 ] [ Designated as safety issue: No ]
  Number of patients alive, awaken, and free of ICU-delirium assessed on the CAM-ICU
  
  
• Proximal muscle weakness [ Time Frame: from day 1 to 7, and at day 14, 21 and 28 ] [ Designated as safety issue: No ]
  Number of patients alive, awaken, cooperative and free of proximal muscle weakness
  
  
• Functional, cognitive and psychological status [ Time Frame: At day 90 and 1 year ] [ Designated as safety issue: No ]
  Functional status (measured on the Barthel scale), depression (measured on the Hospital Anxiety & Depression Scale), Posttraumatic stress disorder (measured on the Impact of Event Scale), Quality of Life (measured on the SF-36) and patient living location
  
  
• Time to weaning onset [ Time Frame: Time from mechancial ventilation initiation to first spontaneous breathing trial, up to day 28 ] [ Designated as safety issue: No ]
  
• Number of patients requiring tracheotomy [ Time Frame: During ICU stay, up to day 28 ] [ Designated as safety issue: No ]
  
• First sitting in chair [ Time Frame: During ICU stay, up to day 28 ] [ Designated as safety issue: No ]
  

In intensive care unit (ICU) patients receiving mechanical ventilation (MV), potent hypnotics and morphinics are frequently administered to increase synchrony with the ventilator, control agitation and decrease discomfort and pain due to the tracheal tube, bed ridding, painful condition and diagnostic or therapeutic procedures.

However, administration sedatives or morphinics is often excessive and may result in deep and prolonged alteration of consciousness, delayed weaning from MV and prolonged MV. and exposes the patient to a higher risk of ventilator-associated pneumonia, ICU delirium and neuromuscular weakness at awakening.

The present randomized multicenter study will compare the day-90 mortality of a group of patients receiving conventional sedation to the mortality of a group of patients receiving sedation administered according to an algorithm aimed to prevent oversedation to the mortality. The algorithm is built on a graduate therapeutic response to increasingly intense symptoms of discomfort, pain, ventilator dyssynchrony and agitation, and includes the use of analgesics, non hypnotic benzodiazepines, neuroleptics, repeated intravenous (IV) boluses of hypnotics and short duration (6 hours) IV hypnotic infusions.