Continuous Processed Neurological Monitor to Guide the Management of Sedation for Patients Receiving Mechanical Ventilation: a Prospective Observational Study to Test the Effects on Delirium, Days on a Ventilator, and Post-Intensive Care Syndrome.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Delirium
研究概览
简要总结
The goal of this multi-site observational study is to compare delirium rates, days on mechanical ventilation, and Post Intensive Care Syndrome (PICS) rates in adult Intensive Care Unit (ICU) patients. The study will examine patients whose sedation and analgesia infusion titration is managed with both Richmond Agitation and Sedation Scale (RASS) and Processed Electroencephalography (pEEG) monitoring vs patients who receive RASS monitoring alone.
The main questions are:
- Compared to RASS monitoring method alone, does the use of 4 channel pEEG monitor in conjunction with RASS to guide the management of sedation and analgesic in patients who are ventilated reduce the average number of delirium days, measured by Intensive Care Delirium Screening Checklist (ICDSC)?
- To determine when compared to RASS monitoring alone if the use of 4 channel pEEG monitor in conjunction with RASS to guide the management of Intravenous (IV) sedation and analgesia in ventilated patients reduces the days a patient spends on a mechanical ventilator when compared to RASS only monitoring from retrospective data.
- To determine when compared to RASS monitoring method alone, does the use of 4 channel pEEG monitor in conjunction with RASS experience lower doses of sedation and analgesia infusions?
- To determine when compared to RASS monitoring method alone, does the use of 4 channel pEEG monitor in conjunction with RASS experience less incidence and duration of PICS?
详细描述
The purpose of this study is to determine the impact of using a 4 channel pEEG monitor to guide sedation and analgesia management in conjunction with RASS in ventilated patients in the ICU on length of time patients experience delirium, number of days patients spend on a ventilator, and incidence of PICS in these same patients.
Participants who are on a mechanical ventilator and on IV sedation or analgesia will be placed on a pEEG monitor on admission to ICU.
Participants will complete a battery of test at discharge, one month post discharge, and three months post discharge to assess for PICS.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 17 Years 至 110 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted to ICU
- •Receive mechanical ventilator support during ICU stay
- •Require IV sedation or analgesic while ventilated
- •Discharged home from the hospital
- •Use of pEEG for sedation or analgesic titration
- •Able to read and speak English
- •Mechanically ventilated greater than 48 hours
- •Aged 17 years +1 day or greater
- •Consent to participate
- •Participants need a computer with a keyboard, internet access, and email access for the questionnaires and assessment and be able to use computer and internet.
排除标准
- •Deceased during hospitalization
- •Intubated at a hospital not included within the study > 12 hours
- •Discharge to rehabilitation facility, long term care, or other outpatient setting
- •Inability to provide informed consent
- •Currently enrolled in any other research study involving drugs or devices
- •Is unable to be screened for delirium during ICU admission.
研究组 & 干预措施
Prospective Cohort
Patients admitted to participating ICUs who meet inclusion criteria monitored by 4 channel pEEG.
干预措施: SedLine (Device)
Retrospective Cohort
Patients admitted to participating ICUs who meet inclusion criteria not monitored by 4 channel pEEG.
结局指标
主要结局
Delirium
时间窗: For the time the patient remains in ICU until discharge from ICU. Average length of stay in ICU is 7 days.
Measured by Intensive Care Delirium Screening Checklist (ICDSC). The items include the assessment of: (1) consciousness ( deep sedation/coma, agitation, normal wakefulness, or light sedation); (2) inattention; (3) disorientation; (4) hallucination, delusion, or psychosis; (5) psychomotor agitation or retardation; (6) inappropriate speech or mood; (7) sleep-wake cycle disturbances; and (8) fluctuation of symptomatology. The maximum score is eight; scores of ≥4 indicate the presence of delirium and score zero is indicate not in delirium. Each item is scored 0-8.
次要结局
- Computerized Neurocognitive Screening Vital Signs(At hospital discharge (4 days +/- 1) average length of stay in hospital 5-90 days, 1 month post discharge, 3 months post discharge)
- Sedation Infusions (Propofol and/or Midazolam)(Measured every 4 hours while the patient remains on the infusion in ICU. Average length of time spent on a sedation infusion is 5 days.)
- Suppression Ratio(From the time pEEG monitoring is initiated until it is discontinued. Average length of time spent on a pEEG monitor is 5 days.)
- Days of Mechanical Ventilation(From the date of intubation until extubation in ICU. Average length of mechanical ventilation is 7 days.)
- Combined Sedation and Analgesia Infusions (Dexmedetomidine and/or Ketamine)(Measured every 4 hours while the patient remains on the infusion in ICU. Average length of time spent on a combined sedation and analgesic infusion is 3 days.)
- Analgesia Infusions (Fentanyl, Morphine, and/or Hydromorphone)(Measured every 4 hours while the patient remains on the infusion in ICU. Average length of time spent on an analgesic infusion is 5 days.)
- Impact of Events Scale-Revised(At hospital discharge (4 days +/- 1) average length of stay in hospital 5-90 days, 1 month post discharge (6 days +/- 1) , 3 months post discharge (6 days +/- 1))
- EuroQol-5D-5L(At hospital discharge (4 days +/- 1) average length of stay in hospital 5-90 days, 1 month post discharge (6 days +/- 1) , 3 months post discharge (6 days +/- 1))
- Hospital Anxiety and Depression Scale(At hospital discharge (4 days +/- 1) average length of stay in hospital 5-90 days, 1 month post discharge (6 days +/- 1) , 3 months post discharge (6 days +/- 1))