The SOMNUS Study: Sedative Optimization Via Monitoring Neurological Status

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Covidien
Information provided by (Responsible Party):
Paula Watson, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00469482
First received: May 3, 2007
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Delirium
Cognitive Impairment
Critically Ill
Device: RASS Targeting plus BIS Monitoring
Other: RASS Targeted
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Randomized Control Trial Using the BIS Monitor to Avoid Over Sedation and Prolonged Neuropsychological Deficits in Mechanically Ventilated ICU Patients

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Number of ventilator free hours and days [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of delirium and coma free days [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Incidence of subacute cognitive dysfunction [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • ICU length of stay [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Hospital length of stay [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Six month mortality [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Biomarkers for neurological injury and inflammation [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • sleep quality [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: June 2007
Estimated Study Completion Date: December 2015
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sedation RASS Targeted
Patient sedation utilizing standard of care methods (RASS Targeted)
Other: RASS Targeted
Patient sedation utilizing standard of care methods (RASS targeted)
Active Comparator: RASS Targeting plus BIS Monitoring
Providing patient sedation utilizing standard of care methods (RASS) plus BIS monitoring.
Device: RASS Targeting plus BIS Monitoring
Providing patient sedation utilizing standard of care methods (RASS) plus BIS monitoring

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00469482

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Covidien
Investigators
Principal Investigator: Paula L. Watson, MD Vanderbilt Universtiy
  More Information

Additional Information:
Publications:

Responsible Party: Paula Watson, Assitant Professor of Medicine, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00469482     History of Changes
Other Study ID Numbers: 061218, SOMNUS
Study First Received: May 3, 2007
Last Updated: June 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Delirium
Cognitive Impairment
Sleep
Polysomnography
Sedation
Mechanical Ventilation
Critical Illness

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

ClinicalTrials.gov processed this record on July 10, 2014