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

NCT01617265 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1180

Last updated 2015-08-26

No results posted yet for this study

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.

Conditions

  • ICU Patients Requiring Invasive Mechanical Ventilation

Interventions

PROCEDURE

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.

PROCEDURE

Usual sedation practice

Sedation and analgesia will be administered according to the usual practices in each participating center.

Sponsors & Collaborators

  • University Hospital, Tours

    collaborator OTHER

  • French Society for Intensive Care

    lead OTHER

Principal Investigators

  • Bernard DE JONGHE, MD · French Society of Intensive Care

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01617265 on ClinicalTrials.gov