Validation of Frontal Limited Lead Electroencephalography (EEG) to Formal Polysomnography (PSG) in the Intensive Care Unit (ICU)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Sleep Stage Correlation
研究概览
简要总结
The purpose of this study is to compare a 2-lead frontal electroencephalogram recording to a formal polysomnography (PSG) in detecting sleep vs. wake and depth of sleep in both healthy and ICU patients.
详细描述
Sleep in the intensive care unit (ICU) is poor and not well understood. Formal polysomnography (PSG) is the gold standard measure, but impractical for critical care. The relative influence of environment, illness and interventions on sleep in critically ill patients is therefore essentially unknown. Interventions to improve sleep have been pragmatic and outcomes subjective or indirect, and uninformed. When it is done, formal PSG in critical illness demonstrates fragmented, shortened, interrupted and non-circadian sleep, with environmental noise, light, and frequent physical stimulation causing arousals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Group 1: Healthy Subjects in Sleep Lab:
- •Inclusion Criteria
- •Age 18 or older
- •Scheduled for a standard of care polysomnography lasting at least 8 hours for any condition
排除标准
- •Patient/Legally Authorized Representative declines consent
- •Group 2: ICU patient, not sedated, not ventilated
- •Inclusion Criteria
- •Age 18 or older
- •Anticipated to stay in intensive care unit overnight (minimum 8 hours)
- •Glasgow Coma Scale score of 13 or great
- •Exclusion Criteria:
- •Intubated with endotracheal tube
- •Sedated (includes sedative drugs such as propofol, Dexmedetomidine, versed infusion above 2mg/hr, ketamine infusion above 0.2 mg/kg/hr).
- •Group 3: ICU patient, sedated and ventilated
- •Inclusion Criteria:
- •Age 18 or older
- •Anticipated to stay in the intensive care unit overnight (minimum 8 hours)
- •Intubated, sedated, and ventilated
- •Exclusion Criteria:
- •Presence of traumatic brain injury
- •Planned extubation in next 8 hours
- •Scheduled to leave the intensive care unit for any reason in the next 8 hours
- •Anticipated life expectancy of less than 24 hours
- •Electroencephalogram monitoring (current or scheduled in the next 8 hours)
- •Hemodynamic instability (defined as: (i) mean arterial pressure <60mmHg for >20 minutes with efforts to raise it or (ii) >2 liter fluid administered in 2h after operating room and anticipating on-going needs for fluid resuscitation or (iii) ICU MD determination of "atypical and profound hemodynamic instability" or (iv) PI determination after evaluation.
- •Refractory hypoxemia - defined as Saturation <88% on Sp02 despite efforts to increase it
- •Hemorrhage - defined as >500cc chest tube output in 2h and anticipated need of more than 2 units of packed red blood cells in immediate post op period. This does NOT include cell-saver.
研究组 & 干预措施
Health Subjects in Sleep Lab
Adult patients (> 18yrs old) scheduled for a standard of care PSG (sleep study) lasting at least 8 hours for any condition. Patients will undergo simultaneous 2-lead limited EEG recording with experimental device. 2-lead limited electroencephalography recording
干预措施: 2-lead limited electroencephalography recording (Device)
ICU patients, not sedated or ventilated
Adult ICU patients (> 18yrs old) anticipated to stay in the ICU overnight (minimum 8 hours) with a Glasgow Coma Scale of 13 or greater, not intubated and not sedated. Patients will undergo simultaneous 2-lead limited electroencephalography recording
干预措施: 2-lead limited electroencephalography recording (Device)
ICU patients, sedated and ventilated
Adult ICU patients (> 18yrs old) who are intubated, sedated, ventilated, and anticipated to stay in the ICU overnight (minimum 8 hours). Patients will undergo simultaneous 2-lead limited electroencephalography recording
干预措施: 2-lead limited electroencephalography recording (Device)
结局指标
主要结局
Sleep Stage Correlation
时间窗: Overnight (with a minimum of 960 epochs)
The correlation of each sleep stage (Wake, NREM1, NREM2, NREM3, REM) as assessed by polysomnography vs. EEG via analysis of 30-second intervals (epochs)
次要结局
- Sleep vs Wake Correlation(Overnight (with a minimum of 960 epochs))
研究者
Joseph Tonna
Associate Director, ECMO Services
University of Utah