Study of a Strategy to Prevent Oversedation in Intensive Care Patients Under Mechanical Ventilation
- Conditions
- ICU Patients Requiring Invasive Mechanical Ventilation
- Interventions
- Procedure: Clinical Procedure to Prevent OversedationProcedure: Usual sedation practice
- Registration Number
- NCT01617265
- Lead Sponsor
- French Society for Intensive Care
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1180
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prevention of oversedation group Clinical Procedure to Prevent Oversedation 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 Usual sedation practice In this arm, sedation will be administered according to the usual practices in each participating center.
- Primary Outcome Measures
Name Time Method Day-90 mortality Mortality at Day 90 after randomization
- Secondary Outcome Measures
Name Time Method 1-yr mortality at 1 yr Mortality at Day 28 at day 28 Hospital mortality at hospital discharge, up to day 90 Number of patients requiring tracheotomy During ICU stay, up to day 28 First sitting in chair During ICU stay, up to day 28 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 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 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 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 from mechancial ventilation initiation to first spontaneous breathing trial, up to day 28
Trial Locations
- Locations (43)
Hôpital Saint-Esprit
🇫🇷Agen, France
CHU d'Angers
🇫🇷Angers, France
Hopital Privé d'Antony
🇫🇷Antony, France
CH d'Argenteuil
🇫🇷Argenteuil, France
Hopital St-Andre
🇫🇷Bordeaux, France
Hopital Avicenne
🇫🇷Bobigny, France
CH Germon et Gauthier
🇫🇷Beuvry, France
Hopital Antoine Beclere
🇫🇷Clamart, France
CHRU de la Cavale Blanche
🇫🇷Brest, France
CH Sud Francilien
🇫🇷Corbeil-Essones, France
Hopital Raymond Poincare
🇫🇷Garches, France
CHU Henri Mondor
🇫🇷Creteil, France
CH St-Joseph St-Luc
🇫🇷Lyon, France
CHD Les Oudairies
🇫🇷la Roche sur Yon, France
CH de Versailles
🇫🇷Le Chesnay, France
Hopital Roger Salengro
🇫🇷Lille, France
CHU Marseille Hopital Nord
🇫🇷Marseilles, France
Groupe Hospitalier Edouard Herriot
🇫🇷Lyon, France
Hopital de la Timone
🇫🇷Marseille, France
CH Princesse Grace
🇫🇷Monaco, France
Hopital Notre-Dame de Bon Secours
🇫🇷Metz, France
CH de Meaux
🇫🇷Meaux, France
GHIRM
🇫🇷Montfermeil, France
Hopital Laennec
🇫🇷Nantes, France
CHR d'Orléans Hopital la Source
🇫🇷Orléans, France
Hopital l'Archet
🇫🇷Nice, France
Hopital St Louis
🇫🇷Paris, France
Institut Mutualiste Montsouris
🇫🇷Paris, France
CH Poissy
🇫🇷Poissy, France
Hopital Tenon
🇫🇷Paris, France
CH Francois Miterrand
🇫🇷Pau, France
CH de la Région d'Annecy
🇫🇷Pringy, France
CH de Pontoise
🇫🇷Pontoise, France
CH Leon Binet
🇫🇷Provins, France
CH de St-Brieuc
🇫🇷St-Brieuc, France
CH de St-Malo
🇫🇷St-Malo, France
Hopital Delafontaine
🇫🇷St-Denis, France
HIA Béjin
🇫🇷St-Mande, France
Hopital Jean Bernard
🇫🇷Valenciennes, France
CHRU Bretonneau
🇫🇷Tours, France
Institut Gustave Roussy
🇫🇷Villejuif, France
CHU Kremlin-Bicetre
🇫🇷Le Kremelin-Bicetre, France
Hopital Ambroise Pare
🇫🇷Boulogne Billancourt, France