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

French Society for Intensive Care

Status: Completed

Conditions: ICU Patients Requiring Invasive Mechanical Ventilation

Treatments: Procedure: Usual sedation practice; Procedure: Clinical Procedure to Prevent Oversedation

Study type: Interventional

Funder types: Other

Identifiers

NCT01617265

2011-004246-18 (EudraCT Number)

SRLF-TG-1-AWARE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,180 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,180 participants in 2 patient groups

Prevention of oversedation group

Experimental group

Description:

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.

Treatment:

Procedure: Clinical Procedure to Prevent Oversedation

Conventional sedation group

Active Comparator group

Description:

In this arm, sedation will be administered according to the usual practices in each participating center.

Treatment:

Procedure: Usual sedation practice