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

August 25, 2015 updated by: French Society for Intensive Care

Prevention of Oversedation in Intensive Care Patients Under Mechanical Ventilation : the AWARE Multicentric Randomized Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

1180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Agen, France, 47923
        • Hôpital Saint-Esprit
      • Angers, France, 49000
        • CHU d'Angers
      • Antony, France, 92166
        • Hopital Prive d'Antony
      • Argenteuil, France, 95100
        • CH d'Argenteuil
      • Beuvry, France, 62408
        • Ch Germon Et Gauthier
      • Bobigny, France, 93000
        • Hôpital Avicenne
      • Bordeaux, France, 33075
        • Hopital St-Andre
      • Boulogne Billancourt, France, 92100
        • Hopital Ambroise Pare
      • Brest, France, 29609
        • CHRU de la Cavale Blanche
      • Clamart, France, 92140
        • Hopital Antoine Beclere
      • Corbeil-Essones, France, 91106
        • CH SUd Francilien
      • Creteil, France, 94010
        • CHU Henri Mondor
      • Garches, France, 92380
        • Hôpital Raymond Poincaré
      • Le Chesnay, France, 78157
        • CH de Versailles
      • Le Kremelin-Bicetre, France, 94270
        • CHU Kremlin-Bicêtre
      • Lille, France, 59037
        • Hôpital Roger Salengro
      • Lyon, France, 69437
        • Groupe Hospitalier Edouard Herriot
      • Lyon, France, 69000
        • CH St-Joseph St-Luc
      • Marseille, France, 13385
        • Hopital de la Timone
      • Marseilles, France, 13015
        • CHU Marseille Hopital Nord
      • Meaux, France, 77104
        • CH de Meaux
      • Metz, France, 57038
        • Hopital Notre-Dame de Bon Secours
      • Monaco, France, 98012
        • CH Princesse Grace
      • Montfermeil, France, 93370
        • GHIRM
      • Nantes, France, 44035
        • Hôpital Laënnec
      • Nice, France, 06202
        • Hôpital l'Archet
      • Orléans, France, 45067
        • CHR d'Orléans Hopital la Source
      • Paris, France, 75014
        • Institut Mutualiste Montsouris
      • Paris, France, 75020
        • Hôpital Tenon
      • Paris, France, 75010
        • Hopital St Louis
      • Pau, France, 64046
        • CH Francois Miterrand
      • Poissy, France, 78300
        • CH Poissy
      • Pontoise, France, 95303
        • CH de Pontoise
      • Pringy, France, 74374
        • CH de la Region d'Annecy
      • Provins, France, 77488
        • CH Leon Binet
      • St-Brieuc, France, 22027
        • CH de St-Brieuc
      • St-Denis, France, 93200
        • Hôpital Delafontaine
      • St-Malo, France, 35403
        • CH de St-Malo
      • St-Mande, France, 94160
        • HIA Béjin
      • Tours, France, 37044
        • CHRU Bretonneau
      • Valenciennes, France, 59322
        • Hopital Jean Bernard
      • Villejuif, France, 94805
        • Institut Gustave Roussy
      • la Roche sur Yon, France, 85925
        • CHD Les Oudairies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Day-90 mortality
Time Frame: Mortality at Day 90 after randomization
Mortality at Day 90 after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality at Day 28
Time Frame: at day 28
at day 28
Hospital mortality
Time Frame: at hospital discharge, up to day 90
at hospital discharge, up to day 90
1-yr mortality
Time Frame: at 1 yr
at 1 yr
Mechanical ventilation duration
Time Frame: From onset of mechanical ventilation to day 28
From onset of mechanical ventilation to day 28
Days alive with no mechanical ventilation
Time Frame: From ICU admission up to day 28
From ICU admission up to day 28
Occurence of ventilator-associated pneumonia
Time Frame: During mechanical ventilation duration, up to day 28
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
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
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
From Day 1 to 7, and at day 14, 21 and 28
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
from day 1 to 7, and at day 14, 21 and 28
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
At day 90 and 1 year
Time to weaning onset
Time Frame: Time from mechancial ventilation initiation to first spontaneous breathing trial, up to day 28
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
During ICU stay, up to day 28
First sitting in chair
Time Frame: During ICU stay, up to day 28
During ICU stay, up to day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French Society for Intensive Care

Collaborators

University Hospital, Tours

Investigators

  • Study Chair: Bernard DE JONGHE, MD, French Society of Intensive Care

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

June 6, 2012

First Submitted That Met QC Criteria

June 8, 2012

First Posted (ESTIMATE)

June 12, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

August 26, 2015

Last Update Submitted That Met QC Criteria

August 25, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SRLF-TG-1-AWARE
  • 2011-004246-18 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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