Study of a Strategy to Prevent Oversedation in Intensive Care Patients Under Mechanical Ventilation
NCT ID: NCT01617265
Last Updated: 2015-08-26
Study Results
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Basic Information
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COMPLETED
NA
1180 participants
INTERVENTIONAL
2012-06-30
2015-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
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.
Conventional sedation group
In this arm, sedation will be administered according to the usual practices in each participating center.
Usual sedation practice
Sedation and analgesia will be administered according to the usual practices in each participating center.
Interventions
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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.
Usual sedation practice
Sedation and analgesia will be administered according to the usual practices in each participating center.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Tours
OTHER
French Society for Intensive Care
OTHER
Responsible Party
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Principal Investigators
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Bernard DE JONGHE, MD
Role: STUDY_CHAIR
French Society of Intensive Care
Locations
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Hôpital Saint-Esprit
Agen, , France
CHU d'Angers
Angers, , France
Hopital Privé d'Antony
Antony, , France
CH d'Argenteuil
Argenteuil, , France
CH Germon et Gauthier
Beuvry, , France
Hopital Avicenne
Bobigny, , France
Hopital St-Andre
Bordeaux, , France
Hopital Ambroise Pare
Boulogne-Billancourt, , France
CHRU de la Cavale Blanche
Brest, , France
Hopital Antoine Beclere
Clamart, , France
CH Sud Francilien
Corbeil-Essones, , France
CHU Henri Mondor
Créteil, , France
Hopital Raymond Poincare
Garches, , France
CHD Les Oudairies
La Roche-sur-Yon, , France
CH de Versailles
Le Chesnay, , France
CHU Kremlin-Bicetre
Le Kremelin-Bicetre, , France
Hopital Roger Salengro
Lille, , France
CH St-Joseph St-Luc
Lyon, , France
Groupe Hospitalier Edouard Herriot
Lyon, , France
CHU Marseille Hopital Nord
Marseille, , France
Hopital de la Timone
Marseille, , France
CH de Meaux
Meaux, , France
Hopital Notre-Dame de Bon Secours
Metz, , France
CH Princesse Grace
Monaco, , France
GHIRM
Montfermeil, , France
Hopital Laennec
Nantes, , France
Hopital l'Archet
Nice, , France
CHR d'Orléans Hopital la Source
Orléans, , France
Hopital St Louis
Paris, , France
Institut Mutualiste Montsouris
Paris, , France
Hopital Tenon
Paris, , France
CH Francois Miterrand
Pau, , France
CH Poissy
Poissy, , France
CH de Pontoise
Pontoise, , France
CH de la Région d'Annecy
Pringy, , France
CH Leon Binet
Provins, , France
CH de St-Brieuc
Saint-Brieuc, , France
Hopital Delafontaine
Saint-Denis, , France
HIA Béjin
Saint-Mandé, , France
CH de St-Malo
St-Malo, , France
CHRU Bretonneau
Tours, , France
Hopital Jean Bernard
Valenciennes, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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References
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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.
Kollef 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.
Constantin 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.
Brook 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.
De 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.
Quenot 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.
Kress 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.
Strom 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.
Treggiari 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.
Ely 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.
SRLF 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.
Other Identifiers
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2011-004246-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SRLF-TG-1-AWARE
Identifier Type: -
Identifier Source: org_study_id
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