Validation of Frontal EEG to Formal Polysomnography in the ICU

Not Applicable

Terminated

• Conditions: Sleep; Sleep Deprivation
• Interventions: Device: 2-lead limited electroencephalography recording

• Registration Number: NCT03322371
• Lead Sponsor: University of Utah

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-10-23
• Study First Submitted QC: 2017-10-23
• Study First Posted: 2017-10-26
• Study Start: 2017-11-06
• Primary Completion: 2020-01-01
• Study Completion: 2020-01-01
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-02
• Last Update Posted: 2021-06-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 44

Inclusion Criteria

• Age 18 or older
• Anticipated to stay in the intensive care unit overnight (minimum 8 hours)
• Intubated, sedated, and ventilated

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Health Subjects in Sleep Lab	2-lead limited electroencephalography recording	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
ICU patients, not sedated or ventilated	2-lead limited electroencephalography recording	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
ICU patients, sedated and ventilated	2-lead limited electroencephalography recording	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

Primary Outcome Measures

Name	Time	Method
Sleep Stage Correlation	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)

Secondary Outcome Measures

Name	Time	Method
Sleep vs Wake Correlation	Overnight (with a minimum of 960 epochs)	The correlation of sleep (NREM1, NREM2, NREM3, REM) vs wake as assessed by polysomnography vs. EEG via analysis of 30-second intervals (epochs)

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States