Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 6, 2012
First Posted Date  ICMJE June 12, 2012
Last Update Posted Date August 26, 2015
Study Start Date  ICMJE June 2012
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2012)
Day-90 mortality [ Time Frame: Mortality at Day 90 after randomization ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01617265 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2012)
  • Mortality at Day 28 [ Time Frame: at day 28 ]
  • Hospital mortality [ Time Frame: at hospital discharge, up to day 90 ]
  • 1-yr mortality [ Time Frame: at 1 yr ]
  • Mechanical ventilation duration [ Time Frame: From onset of mechanical ventilation to day 28 ]
  • Days alive with no mechanical ventilation [ Time Frame: From ICU admission up to day 28 ]
  • Occurence of ventilator-associated pneumonia [ Time Frame: During mechanical ventilation duration, up to day 28 ]
  • Use of non-invasive ventilation after extubation [ Time Frame: From extubation to ICU discharge up to day 28 ]
  • Duration of ICU stay [ Time Frame: From ICU admission to ICU discharge or death in ICU, up to day 90 ]
  • 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
  • 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
  • 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
  • Time to weaning onset [ Time Frame: Time from mechancial ventilation initiation to first spontaneous breathing trial, up to day 28 ]
  • Number of patients requiring tracheotomy [ Time Frame: During ICU stay, up to day 28 ]
  • First sitting in chair [ Time Frame: During ICU stay, up to day 28 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2012)
  • Mortality at Day 28 [ Time Frame: at day 28 ]
  • Hospital mortality [ Time Frame: at hospital discharge, up to day 90 ]
  • 1-yr mortality [ Time Frame: at 1 yr ]
  • MV duration [ Time Frame: From onset of mechanical ventilation to day 28 ]
  • Days alive with no mechanical ventilation [ Time Frame: From ICU admission up to day 28 ]
  • Occurence of ventilator-associated pneumonia [ Time Frame: During mechanical ventilation duration, up to day 28 ]
  • Use of non-invasive ventilation after extubation [ Time Frame: From extubation to ICU discharge up to day 28 ]
  • Duration of ICU stay [ Time Frame: From ICU admission to ICU discharge or death in ICU, up to day 90 ]
  • 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
  • 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
  • Functional, cognitive and psychological status [ Time Frame: At day 90 and 1 year ]
    Functional status (measured on the Barthel scale), depression (measured on the HADS), PTSD (measured on the IES), QOL (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 ]
  • Number of patients requiring tracheotomy [ Time Frame: During ICU stay, up to day 28 ]
  • First sitting in chair [ Time Frame: During ICU stay, up to day 28 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of a Strategy to Prevent Oversedation in Intensive Care Patients Under Mechanical Ventilation
Official Title  ICMJE Prevention of Oversedation in Intensive Care Patients Under Mechanical Ventilation : the AWARE Multicentric Randomized Trial
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE ICU Patients Requiring Invasive Mechanical Ventilation
Intervention  ICMJE
  • 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.
  • Procedure: Usual sedation practice
    Sedation and analgesia will be administered according to the usual practices in each participating center.
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Clinical Procedure to Prevent Oversedation
  • Active Comparator: Conventional sedation group
    In this arm, sedation will be administered according to the usual practices in each participating center.
    Intervention: Procedure: Usual sedation practice
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 25, 2015)
1180
Original Estimated Enrollment  ICMJE
 (submitted: June 8, 2012)
2720
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01617265
Other Study ID Numbers  ICMJE SRLF-TG-1-AWARE
2011-004246-18 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party French Society for Intensive Care
Study Sponsor  ICMJE French Society for Intensive Care
Collaborators  ICMJE University Hospital, Tours
Investigators  ICMJE
Study Chair: Bernard DE JONGHE, MD French Society of Intensive Care
PRS Account French Society for Intensive Care
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP