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The SOMNUS Study: Sedative Optimization Via Monitoring Neurological Status (SOMNUS)

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ClinicalTrials.gov Identifier: NCT00469482
Recruitment Status : Completed
First Posted : May 4, 2007
Last Update Posted : March 8, 2018
Sponsor:
Collaborator:
Medtronic - MITG
Information provided by (Responsible Party):
Wes Ely, Vanderbilt University Medical Center

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 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.

Condition or disease Intervention/treatment Phase
Delirium Cognitive Impairment Critically Ill Other: Sedation,RASS Targeted plus BIS Monitoring Other: Sedation, RASS Targeted Not Applicable

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 mechanical ventilation, have adverse hemodynamic effects, disturb sleep architecture, and have been determined to be an independent risk factor for ICU delirium. Delirium is an independent determinant of longer hospital stay, higher costs, and higher mortality, and the presence of delirium is highly predictive of long-term neurocognitive deficits. In consideration of these facts, better methods are needed to guide sedation, avoid oversedation, and possibly reduce delirium.

Current guidelines recommend titration of sedation to a goal level based on bedside evaluation using a validated assessment tool, e.g. the Richmond Agitation and Sedation Scale. These assessment tools, however, are underused and many ICU patients are oversedated with well described consequences. A practical method by which to determine where a patient lies may prove beneficial in optimizing our delivery of sedatives and improving patient outcomes.

While conventional EEG monitoring is not practical in the ICU, bispectral index (BIS) monitoring may be easily used in this clinical setting. BIS monitoring may provide a means to assess sedation level in unresponsive or paralyzed ICU patients and to decrease the total amount of sedatives/analgesics administered. Additional benefits of a combined clinical sedation scale and BIS-monitoring approach could include a decreased incidence and/or duration of delirium as well as a decreased incidence and severity of ICU-associated prolonged neurocognitive deficits.

The specific aims of this study are as follows:

Aim 1: To determine if sedative and analgesic medication delivery guided by clinical sedation scales and BIS monitor parameters of over-sedation will decrease time on mechanical ventilation.

Aim 2: To determine if sedative and analgesic medication delivery guided by clinical sedation scales and BIS monitor parameters of over-sedation will decrease the duration of delirium and coma when compared to the use of clinical sedations scales alone.

Aim 3: To determine if sedative and analgesic medication delivery guided by clinical sedation scales and BIS monitor parameters of over-sedation will decrease the incidence and severity of subacute cognitive impairment when compared to the use of clinical sedation scales alone.

Aim 4: To characterize polysomnography findings in critically ill patients at various BIS levels.

Aim 5: To determine if poor sleep quality is a factor in post critical illness neurocognitive dysfunction.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Control Trial Using the BIS Monitor to Avoid Over Sedation and Prolonged Neuropsychological Deficits in Mechanically Ventilated ICU Patients
Study Start Date : June 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Sedation, RASS Targeted
Patient sedation utilizing standard of care methods (RASS Targeted)
Other: Sedation, RASS Targeted
Patient sedation utilizing standard of care methods (RASS targeted)
Active Comparator: Sedation,RASS Targeted plus BIS Monitoring
Providing patient sedation utilizing standard of care methods (RASS) plus BIS monitoring.
Other: Sedation,RASS Targeted plus BIS Monitoring
Providing patient sedation utilizing standard of care methods (RASS) plus BIS monitoring



Primary Outcome Measures :
  1. Number of ventilator free hours and days [ Time Frame: while in ICU, appoximately 3-7 days ]

Secondary Outcome Measures :
  1. Number of delirium and coma free days [ Time Frame: while in ICU, appoximately 3-7 days) ]
  2. Incidence of subacute cognitive dysfunction using RBANS- Repeatable Battery for the Assessment of Neuropsychological Status, [ Time Frame: 3 months ]
  3. Incidence of subacute cognitive dysfunction using TRAILS A&B [ Time Frame: 3 months ]
  4. Incidence of subacute cognitive dysfunction using SF-36 - Short Form Health Survey [ Time Frame: 3 months ]
  5. Incidence of subacute cognitive dysfunction using MMSE - Mini Mental State Examination [ Time Frame: 3 months ]
  6. Incidence of subacute cognitive dysfunction using IADLs - instrumental activities of daily living [ Time Frame: 3 months ]
  7. Incidence of subacute cognitive dysfunction using AD8- ADL - activities of daily living [ Time Frame: 3 months ]
  8. Incidence of subacute cognitive dysfunction using APACHE II - Acute Physiologic and Chronic Health Evaluation II score [ Time Frame: 3 months ]
  9. ICU length of stay [ Time Frame: while in ICU, appoximately 3-7 days ]
  10. Hospital length of stay [ Time Frame: while in hospital, usually 5-10 days ]
  11. Six month mortality [ Time Frame: 6 months ]
  12. Biomarkers for neurological injury and inflammation, Neuron-Specific Enolase (NSE) [ Time Frame: Baseline, Day 3 and at Ventilator removal (appoximately day 3-7) ]
  13. Biomarkers for neurological injury and inflammation, S100 [ Time Frame: Baseline, Day 3 and at Ventilator removal (appoximately day 3-7) ]
  14. Biomarkers for neurological injury and inflammation, IL-6 [ Time Frame: Baseline, Day 3 and at Ventilator removal (appoximately day 3-7) ]
  15. Biomarkers for neurological injury and inflammation, C Reactive Protein (CRP) [ Time Frame: Baseline, Day 3 and at Ventilator removal (appoximately day 3-7) ]
  16. sleep quality [ Time Frame: within 24 hours of enrollment through day 3-7 ]
    measured with continuous polysomnography



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00469482


Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Medtronic - MITG
Investigators
Principal Investigator: Wes Ely, MD Vanderbilt Universtiy

Additional Information:
Publications:

Responsible Party: Wes Ely, Professor of Medicine, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00469482     History of Changes
Other Study ID Numbers: 061218
SOMNUS ( Other Identifier: Aspect Medical Systems, Inc. )
First Posted: May 4, 2007    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: March 2018

Keywords provided by Wes Ely, Vanderbilt University Medical Center:
Delirium
Cognitive Impairment
Sleep
Polysomnography
Sedation
Mechanical Ventilation
Critical Illness

Additional relevant MeSH terms:
Cognitive Dysfunction
Critical Illness
Delirium
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Disease Attributes
Pathologic Processes
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms