Validation of Frontal EEG to Formal Polysomnography in the ICU



Status:Recruiting
Conditions:Insomnia Sleep Studies
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:11/8/2018
Start Date:November 6, 2017
End Date:November 2018
Contact:Joseph Tonna, MD, FAAEM
Email:joseph.tonna@hsc.utah.edu
Phone:801.587.9373

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Validation of Frontal Limited Lead Electroencephalography (EEG) to Formal Polysomnography (PSG) in the Intensive Care Unit (ICU)

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.

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.

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

Exclusion Criteria

- 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.
We found this trial at
1
site
201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Phone: 801-587-7572
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