The SOMNUS Study: Sedative Optimization Via Monitoring Neurological Status

Not Applicable

Completed

• Conditions: Critically Ill; Delirium; Cognitive Impairment
• Interventions: Other: Sedation,RASS Targeted plus BIS Monitoring; Other: Sedation, RASS Targeted

• Registration Number: NCT00469482
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2007-05-03
• Study First Submitted QC: 2007-05-03
• Study First Posted: 2007-05-04
• Study Start: 2007-06
• Primary Completion: 2008-10
• Study Completion: 2016-09
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-06
• Last Update Posted: 2018-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sedation,RASS Targeted plus BIS Monitoring	Sedation,RASS Targeted plus BIS Monitoring	Providing patient sedation utilizing standard of care methods (RASS) plus BIS monitoring.
Sedation, RASS Targeted	Sedation, RASS Targeted	Patient sedation utilizing standard of care methods (RASS Targeted)

Primary Outcome Measures

Name	Time	Method
Number of ventilator free hours and days	while in ICU, appoximately 3-7 days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States