Status:
COMPLETED
The SOMNUS Study: Sedative Optimization Via Monitoring Neurological Status
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
Medtronic - MITG
Conditions:
Delirium
Cognitive Impairment
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A combined strategy of Richmond Agitation and Sedation Scale (RASS) clinical targeting plus bispectral index (BIS) guided sedation in mechanically ventilated, critically ill patients will decrease tim...
Detailed Description
Sedatives and analgesics are used to maintain comfort in almost all mechanically ventilated patients. Unfortunately, these medications also have many deleterious effects. Sedatives increase time on me...
Eligibility Criteria
Inclusion
- Male or female adult patients admitted to the ICU for critical illnesses requiring mechanical ventilation with expectation of being mechanically ventilated for greater than 24 hours. Subjects must have an actual or a target RASS of -3 or deeper with 48 hours of initiation of mechanical ventilation.
Exclusion
- Subjects who are less than 18 years old.
- Inability to obtain informed consent from the patient or his/her surrogate.
- Subjects admitted with alcohol or drug overdoses, suicide attempts, or alcohol/delirium with tremors.
- Subjects with documented moderate to severe dementia.
- Subjects with anoxic brain injuries, strokes, neurotrauma, or neuromuscular disorders such as myasthenia gravis or Guillain Barre syndrome.
- Subjects whose family and/or physician have not committed to aggressive support for 72 hours or who are likely to withdraw within 72 hours.
- Subjects who are moribund or are not expected to survive hospital discharge due to preexisting uncorrectable medical condition.
- Subjects who have either Child-Pugh Class B or C cirrhosis.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00469482
Start Date
June 1 2007
End Date
September 1 2016
Last Update
March 8 2018
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232