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

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ClinicalTrials.gov Identifier: NCT01617265
Recruitment Status : Completed
First Posted : June 12, 2012
Last Update Posted : August 26, 2015
Sponsor:
Collaborator:
University Hospital, Tours
Information provided by (Responsible Party):
French Society for Intensive Care

Brief Summary:
The purpose of the present study is to determine whether administration of sedation according to a strategy including a bundle of measures to prevent oversedation is associated with a reduction in mortality of intensive care unit patients requiring mechanical ventilation, compared to administration of sedation according to usual practices.

Condition or disease Intervention/treatment Phase
ICU Patients Requiring Invasive Mechanical Ventilation Procedure: Clinical Procedure to Prevent Oversedation Procedure: Usual sedation practice Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention of Oversedation in Intensive Care Patients Under Mechanical Ventilation : the AWARE Multicentric Randomized Trial
Study Start Date : June 2012
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Arm Intervention/treatment
Experimental: Prevention of oversedation group
In this arm sedation and analgesia will be administered according to a bundle of measures aimed at limiting oversedation, including repeated assessment of patients needs and graduate therapeutic response to control pain, discomfort, poor synchrony with the ventilator and agitation. The therapeutic options include non hypnotic anxiolytics, repeated intravenous (IV) hypnotics boluses, short-duration (6 hours) IV hypnotics infusion and round the clock IV hypnotics infusion.
Procedure: Clinical Procedure to Prevent Oversedation
Sedation and analgesia will be administered according to a bundle of measures aimed at limiting oversedation, including repeated assessment of patients needs and graduate therapeutic response to control pain, discomfort, poor synchrony with the ventilator and agitation. The therapeutic options include non hypnotic anxiolytics, repeated IV hypnotics boluses, short-duration (6 hours) IV hypnotics infusion and round the clock IV hypnotics infusion.

Active Comparator: Conventional sedation group
In this arm, sedation will be administered according to the usual practices in each participating center.
Procedure: Usual sedation practice
Sedation and analgesia will be administered according to the usual practices in each participating center.




Primary Outcome Measures :
  1. Day-90 mortality [ Time Frame: Mortality at Day 90 after randomization ]

Secondary Outcome Measures :
  1. Mortality at Day 28 [ Time Frame: at day 28 ]
  2. Hospital mortality [ Time Frame: at hospital discharge, up to day 90 ]
  3. 1-yr mortality [ Time Frame: at 1 yr ]
  4. Mechanical ventilation duration [ Time Frame: From onset of mechanical ventilation to day 28 ]
  5. Days alive with no mechanical ventilation [ Time Frame: From ICU admission up to day 28 ]
  6. Occurence of ventilator-associated pneumonia [ Time Frame: During mechanical ventilation duration, up to day 28 ]
  7. Use of non-invasive ventilation after extubation [ Time Frame: From extubation to ICU discharge up to day 28 ]
  8. Duration of ICU stay [ Time Frame: From ICU admission to ICU discharge or death in ICU, up to day 90 ]
  9. ICU confusion [ Time Frame: From Day 1 to 7, and at day 14, 21 and 28 ]
    Number of patients alive, awaken, and free of ICU-delirium assessed on the CAM-ICU

  10. Proximal muscle weakness [ Time Frame: from day 1 to 7, and at day 14, 21 and 28 ]
    Number of patients alive, awaken, cooperative and free of proximal muscle weakness

  11. Functional, cognitive and psychological status [ Time Frame: At day 90 and 1 year ]
    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

  12. Time to weaning onset [ Time Frame: Time from mechancial ventilation initiation to first spontaneous breathing trial, up to day 28 ]
  13. Number of patients requiring tracheotomy [ Time Frame: During ICU stay, up to day 28 ]
  14. First sitting in chair [ Time Frame: During ICU stay, up to day 28 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 and older
  • Admission to ICU with expected mechanical ventilation duration > 48 hrs
  • Mechanical ventilation in ICU for less than 12 hours
  • Information provided to the patient or proxy

Exclusion Criteria:

  • ICU Admission after cardiac arrest
  • Acute or chronic neuromuscular disease
  • Tracheotomy on ICU admission
  • Acute cerebral injury with intracranial hypertension requiring continuous IV sedation with or without neuromuscular blockade
  • Status epilepticus
  • Treatment withdrawal decision
  • Pregnancy, breast feeding
  • Concurrent participation in another interventional study requiring a change in usual practice of sedation or mechanical ventilation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01617265


Locations
Show Show 43 study locations
Sponsors and Collaborators
French Society for Intensive Care
University Hospital, Tours
Investigators
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Study Chair: Bernard DE JONGHE, MD French Society of Intensive Care
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: French Society for Intensive Care
ClinicalTrials.gov Identifier: NCT01617265    
Other Study ID Numbers: SRLF-TG-1-AWARE
2011-004246-18 ( EudraCT Number )
First Posted: June 12, 2012    Key Record Dates
Last Update Posted: August 26, 2015
Last Verified: August 2015
Keywords provided by French Society for Intensive Care:
intensive care
mechanical ventilation
sedatives
morphinics
oversedation
mortality
midazolam
propofol
pain
agitation