The SOMNUS Study: Sedative Optimization Via Monitoring Neurological Status
Completed · Not applicable
Conditions studied: Delirium, Cognitive Impairment, Critically Ill
In brief
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 time on mechanical ventilation, decrease the duration of intensive care unit (ICU) delirium and coma, and will improve subacute neurocognitive function when compared to sedation guided by RASS targeting alone.
Key facts
- Study ID
- NCT00469482
- Run by
- Vanderbilt University Medical Center
- People needed
- 28
- Starts
- 2007-06-01
- Expected to finish
- 2016-09-01
- Last updated by the study team
- 2018-03-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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