A Randomized Control Trial Using the BIS Monitor to Avoid Over Sedation and Prolonged Neuropsychological Deficits in Mechanically Ventilated ICU Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Number of ventilator free hours and days
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Sedation, RASS Targeted
Patient sedation utilizing standard of care methods (RASS Targeted)
干预措施: Sedation, RASS Targeted (Other)
Sedation,RASS Targeted plus BIS Monitoring
Providing patient sedation utilizing standard of care methods (RASS) plus BIS monitoring.
干预措施: Sedation,RASS Targeted plus BIS Monitoring (Other)
结局指标
主要结局
Number of ventilator free hours and days
时间窗: while in ICU, appoximately 3-7 days
次要结局
- ICU length of stay(while in ICU, appoximately 3-7 days)
- Number of delirium and coma free days(while in ICU, appoximately 3-7 days))
- Incidence of subacute cognitive dysfunction using MMSE - Mini Mental State Examination(3 months)
- 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)
研究者
Wes Ely
Professor of Medicine
Vanderbilt University Medical Center