Validation of Frontal EEG to Formal Polysomnography in the ICU

Stopped early · Not applicable

Conditions studied: Sleep Deprivation, Sleep

In brief

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.

Key facts

Study ID

NCT03322371

Run by

University of Utah

People needed

44

Starts

2017-11-06

Expected to finish

2020-01-01

Last updated by the study team

2021-06-08

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Age 18 or older
• Scheduled for a standard of care polysomnography lasting at least 8 hours for any condition

You may not qualify if…

• 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.

Where it is running

• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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