CompletedNot Applicable

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

France1,180 participantsStarted 2012-06

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Day-90 mortality

Timeframe: Mortality at Day 90 after randomization

Trial details

NCT IDNCT01617265

SponsorFrench Society for Intensive Care

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-06

View on ClinicalTrials.gov More ICU Patients Requiring Invasive Mechanical Ventilation trials