Sedation in the Intensive Care Unit

Trial on The Efficacy of Sedation in Mechanically Ventilated Critically Ill Patients

High-risk critically ill patients often require mechanical ventilation either to primarily support the respiratory function or when the ventilation is insufficient to maintain adequate gas exchanges as a result of other organ impairment. In order to tolerate this aggressive mechanical support, enhance patient synchrony with the ventilator, and relieve pain and anxiety, analgesia and sedation are provided. It is suggested that an inappropriate use of sedation and analgesia may prolong the duration of mechanical ventilation and increase the risk of specific adverse outcomes such as ventilator associated pneumonia. Despite the widespread use of sedation, little information is available concerning the effect of varying the level of sedation on patients' subsequent mental health. We designed a randomized controlled trial to investigate the efficacy of sedation with the goal of maintaining the patient cooperative and interactive compared to the administration of sedation with the goal of maintaining the patient sedated. The first goal will be achieved by a discontinuous injection of a sedative, while the second goal will be achieved by a continuous infusion of the same sedative. In both groups pain relief will be provided in the same fashion with equal endpoints on a pain scoring scale. Our primary aim is to investigate whether differences in the occurrence of post-traumatic stress disorders (PTSD), anxiety, and depression are related to the choice of sedation-analgesia strategies. Secondary endpoints include the length of ICU stay, as indicated by the time to discharge from the ICU, the time to separation from mechanical ventilation, the rates of pulmonary and extra-pulmonary complications, and hospital length of stay. These endpoints will be compared between the two groups.

Study Overview

• Status: Unknown
• Conditions: Critical Illness; Respiratory Failure
• Intervention / Treatment: Drug: midazolam with 2 different levels of sedation scores

• Study Type: Interventional
• Enrollment: 126
• Phase: Phase 3

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1211
    • Geneva University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Critically ill patients requiring mechanical ventilation

Exclusion Criteria:

• Neurological conditions or neuromuscular disease
• Chronic renal failure, liver failure
• Allergy to benzodiazepines or morphine
• Drug overdose
• Pregnancy
• Non-cooperative
• Treatment with HIV protease inhibitors or erythromycin
• Refusal of consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Depression
Anxiety
Post-traumatic stress disorders (PTSD)

Secondary Outcome Measures

Outcome Measure
Time to discharge from the Intensive Care Unit
Time to separation from mechanical ventilation
Rates of pulmonary and extra-pulmonary complications Hospital length of stay

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Collaborators: Swiss National Science Foundation
• Investigators: Principal Investigator: Miriam M Treggiari, MD, University Hospital, Geneva

Study record dates

Study Major Dates

• Study Start: February 1, 2003
• Study Completion: January 1, 2007

Study Registration Dates

• First Submitted: September 15, 2005
• First Submitted That Met QC Criteria: September 15, 2005
• First Posted (Estimate): September 22, 2005

Study Record Updates

• Last Update Posted (Estimate): January 11, 2007
• Last Update Submitted That Met QC Criteria: January 9, 2007
• Last Verified: January 1, 2007

More Information

Terms related to this study

• Keywords: Sedation, mechanical ventilation
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Disease Attributes; Respiratory Insufficiency; Critical Illness; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam
• Other Study ID Numbers: 3200-068312; 2002DR2266