Sedation in the Intensive Care Unit
Primary Purpose
Critical Illness, Respiratory Failure
Status
Unknown status
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
midazolam with 2 different levels of sedation scores
Sponsored by
About this trial
This is an interventional prevention trial for Critical Illness focused on measuring Sedation, mechanical ventilation
Eligibility Criteria
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
Sites / Locations
- Geneva University Hospitals
Outcomes
Primary Outcome Measures
Post-traumatic stress disorders (PTSD)
Anxiety
Depression
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00221520
First Posted
September 15, 2005
Last Updated
January 9, 2007
Sponsor
University Hospital, Geneva
Collaborators
Swiss National Science Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00221520
Brief Title
Sedation in the Intensive Care Unit
Official Title
Trial on The Efficacy of Sedation in Mechanically Ventilated Critically Ill Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Unknown status
Study Start Date
February 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Geneva
Collaborators
Swiss National Science Foundation
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Respiratory Failure
Keywords
Sedation, mechanical ventilation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
126 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
midazolam with 2 different levels of sedation scores
Primary Outcome Measure Information:
Title
Post-traumatic stress disorders (PTSD)
Title
Anxiety
Title
Depression
Secondary Outcome Measure Information:
Title
Time to discharge from the Intensive Care Unit
Title
Time to separation from mechanical ventilation
Title
Rates of pulmonary and extra-pulmonary complications Hospital length of stay
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miriam M Treggiari, MD
Organizational Affiliation
University Hospital, Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geneva University Hospitals
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland
12. IPD Sharing Statement
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Sedation in the Intensive Care Unit
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