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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004246-18 | EudraCT Number |
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| Name | Class |
|---|---|
| University Hospital, Tours | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prevention of oversedation group | Experimental | 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. |
|
| Conventional sedation group | Active Comparator | In this arm, sedation will be administered according to the usual practices in each participating center. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical Procedure to Prevent Oversedation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Day-90 mortality | Mortality at Day 90 after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality at Day 28 | at day 28 | |
| Hospital mortality | at hospital discharge, up to day 90 | |
| 1-yr mortality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernard DE JONGHE, MD | French Society of Intensive Care | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Saint-Esprit | Agen | 47923 | France | |||
| CHU d'Angers |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17413906 | Background | 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. | |
| 9726743 |
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|
| Usual sedation practice | Procedure | Sedation and analgesia will be administered according to the usual practices in each participating center. |
|
| 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 |
| Occurence of ventilator-associated pneumonia | During mechanical ventilation duration, up to day 28 |
| Use of non-invasive ventilation after extubation | From extubation to ICU discharge up to day 28 |
| Duration of ICU stay | From ICU admission to ICU discharge or death in ICU, up to day 90 |
| ICU confusion | 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 | 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 | 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 from mechancial ventilation initiation to first spontaneous breathing trial, up to day 28 |
| Number of patients requiring tracheotomy | During ICU stay, up to day 28 |
| First sitting in chair | During ICU stay, up to day 28 |
| 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 |
| 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. |
| 20392591 | Background | 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. |
| 10628598 | Background | 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. |
| 15644658 | Background | 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. |
| 17855817 | Background | 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. |
| 10816184 | Background | 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. |
| 20116842 | Background | 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. |
| 19602975 | Background | 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. |
| 15082703 | Background | 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. |
| 30242747 | Derived | 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. |
| ID | Term |
|---|---|
| D010146 | Pain |
| D011595 | Psychomotor Agitation |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020820 | Dyskinesias |
| D009422 | Nervous System Diseases |
| D011596 | Psychomotor Disorders |
| D019954 | Neurobehavioral Manifestations |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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