Study of a Strategy to Prevent Oversedation in Intensive Care Patients Under Mechanical Ventilation
AWARE
Prevention of Oversedation in Intensive Care Patients Under Mechanical Ventilation : the AWARE Multicentric Randomized Trial
2 other identifiers
interventional
1,180
1 country
43
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2012
Typical duration for not_applicable
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 6, 2012
CompletedFirst Posted
Study publicly available on registry
June 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedAugust 26, 2015
August 1, 2015
3 years
June 6, 2012
August 25, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Day-90 mortality
Mortality at Day 90 after randomization
Secondary Outcomes (14)
Mortality at Day 28
at day 28
Hospital mortality
at hospital discharge, up to day 90
1-yr mortality
at 1 yr
Mechanical ventilation duration
From onset of mechanical ventilation to day 28
Days alive with no mechanical ventilation
From ICU admission up to day 28
- +9 more secondary outcomes
Study Arms (2)
Prevention of oversedation group
EXPERIMENTALIn 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.
Conventional sedation group
ACTIVE COMPARATORIn this arm, sedation will be administered according to the usual practices in each participating center.
Interventions
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.
Sedation and analgesia will be administered according to the usual practices in each participating center.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- French Society for Intensive Carelead
- University Hospital, Tourscollaborator
Study Sites (43)
Hôpital Saint-Esprit
Agen, 47923, France
CHU d'Angers
Angers, 49000, France
Hopital Privé d'Antony
Antony, 92166, France
CH d'Argenteuil
Argenteuil, 95100, France
CH Germon et Gauthier
Beuvry, 62408, France
Hopital Avicenne
Bobigny, 93000, France
Hopital St-Andre
Bordeaux, 33075, France
Hopital Ambroise Pare
Boulogne-Billancourt, 92100, France
CHRU de la Cavale Blanche
Brest, 29609, France
Hopital Antoine Beclere
Clamart, 92140, France
CH Sud Francilien
Corbeil-Essones, 91106, France
CHU Henri Mondor
Créteil, 94010, France
Hopital Raymond Poincare
Garches, 92380, France
CHD Les Oudairies
La Roche-sur-Yon, 85925, France
CH de Versailles
Le Chesnay, 78157, France
CHU Kremlin-Bicetre
Le Kremelin-Bicetre, 94270, France
Hopital Roger Salengro
Lille, 59037, France
CH St-Joseph St-Luc
Lyon, 69000, France
Groupe Hospitalier Edouard Herriot
Lyon, 69437, France
CHU Marseille Hopital Nord
Marseille, 13015, France
Hopital de la Timone
Marseille, 13385, France
CH de Meaux
Meaux, 77104, France
Hopital Notre-Dame de Bon Secours
Metz, 57038, France
CH Princesse Grace
Monaco, 98012, France
GHIRM
Montfermeil, 93370, France
Hopital Laennec
Nantes, 44035, France
Hopital l'Archet
Nice, 06202, France
CHR d'Orléans Hopital la Source
Orléans, 45067, France
Hopital St Louis
Paris, 75010, France
Institut Mutualiste Montsouris
Paris, 75014, France
Hopital Tenon
Paris, 75020, France
CH Francois Miterrand
Pau, 64046, France
CH Poissy
Poissy, 78300, France
CH de Pontoise
Pontoise, 95303, France
CH de la Région d'Annecy
Pringy, 74374, France
CH Leon Binet
Provins, 77488, France
CH de St-Brieuc
Saint-Brieuc, 22027, France
Hopital Delafontaine
Saint-Denis, 93200, France
HIA Béjin
Saint-Mandé, 94160, France
CH de St-Malo
St-Malo, 35403, France
CHRU Bretonneau
Tours, 37044, France
Hopital Jean Bernard
Valenciennes, 59322, France
Institut Gustave Roussy
Villejuif, 94805, France
Related Publications (11)
Payen JF, Chanques G, Mantz J, Hercule C, Auriant I, Leguillou JL, Binhas M, Genty C, Rolland C, Bosson JL. Current practices in sedation and analgesia for mechanically ventilated critically ill patients: a prospective multicenter patient-based study. Anesthesiology. 2007 Apr;106(4):687-95; quiz 891-2. doi: 10.1097/01.anes.0000264747.09017.da.
PMID: 17413906BACKGROUNDKollef MH, Levy NT, Ahrens TS, Schaiff R, Prentice D, Sherman G. The use of continuous i.v. sedation is associated with prolongation of mechanical ventilation. Chest. 1998 Aug;114(2):541-8. doi: 10.1378/chest.114.2.541.
PMID: 9726743BACKGROUNDConstantin JM, Chanques G, De Jonghe B, Sanchez P, Mantz J, Payen JF, Sztark F, Richebe P, Lagneau F, Capdevila X, Bazin JE, Lefrant JY. [Current use of sedation and analgesia: 218 resuscitations in France services practices survey]. Ann Fr Anesth Reanim. 2010 May;29(5):339-46. doi: 10.1016/j.annfar.2010.01.014. Epub 2010 Apr 13. French.
PMID: 20392591BACKGROUNDBrook AD, Ahrens TS, Schaiff R, Prentice D, Sherman G, Shannon W, Kollef MH. Effect of a nursing-implemented sedation protocol on the duration of mechanical ventilation. Crit Care Med. 1999 Dec;27(12):2609-15. doi: 10.1097/00003246-199912000-00001.
PMID: 10628598BACKGROUNDDe Jonghe B, Bastuji-Garin S, Fangio P, Lacherade JC, Jabot J, Appere-De-Vecchi C, Rocha N, Outin H. Sedation algorithm in critically ill patients without acute brain injury. Crit Care Med. 2005 Jan;33(1):120-7. doi: 10.1097/01.ccm.0000150268.04228.68.
PMID: 15644658BACKGROUNDQuenot JP, Ladoire S, Devoucoux F, Doise JM, Cailliod R, Cunin N, Aube H, Blettery B, Charles PE. Effect of a nurse-implemented sedation protocol on the incidence of ventilator-associated pneumonia. Crit Care Med. 2007 Sep;35(9):2031-6. doi: 10.1097/01.ccm.0000282733.83089.4d.
PMID: 17855817BACKGROUNDKress JP, Pohlman AS, O'Connor MF, Hall JB. Daily interruption of sedative infusions in critically ill patients undergoing mechanical ventilation. N Engl J Med. 2000 May 18;342(20):1471-7. doi: 10.1056/NEJM200005183422002.
PMID: 10816184BACKGROUNDStrom T, Martinussen T, Toft P. A protocol of no sedation for critically ill patients receiving mechanical ventilation: a randomised trial. Lancet. 2010 Feb 6;375(9713):475-80. doi: 10.1016/S0140-6736(09)62072-9. Epub 2010 Jan 29.
PMID: 20116842BACKGROUNDTreggiari MM, Romand JA, Yanez ND, Deem SA, Goldberg J, Hudson L, Heidegger CP, Weiss NS. Randomized trial of light versus deep sedation on mental health after critical illness. Crit Care Med. 2009 Sep;37(9):2527-34. doi: 10.1097/CCM.0b013e3181a5689f.
PMID: 19602975BACKGROUNDEly EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753.
PMID: 15082703BACKGROUNDSRLF Trial Group. Impact of oversedation prevention in ventilated critically ill patients: a randomized trial-the AWARE study. Ann Intensive Care. 2018 Sep 21;8(1):93. doi: 10.1186/s13613-018-0425-3.
PMID: 30242747DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Bernard DE JONGHE, MD
French Society of Intensive Care
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2012
First Posted
June 12, 2012
Study Start
June 1, 2012
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
August 26, 2015
Record last verified: 2015-08