Validation of Frontal EEG to Formal Polysomnography in the ICU

NCT ID: NCT03322371

Last Updated: 2021-06-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-06
• Study Completion Date: 2020-01-01

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.

Conditions

Sleep Deprivation; Sleep

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

2-lead limited electroencephalography recording

Intervention Type: DEVICE

The EEG recording device will be placed in conjunction with the standard formal polysomnography (PSG). The EEG device will remain in place as long as PSG leads are connected to the subject and PSG machine.

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

Group Type: OTHER

2-lead limited electroencephalography recording

Intervention Type: DEVICE

The EEG recording device will be placed in conjunction with the standard formal polysomnography (PSG). The EEG device will remain in place as long as PSG leads are connected to the subject and PSG machine.

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

Group Type: OTHER

2-lead limited electroencephalography recording

Intervention Type: DEVICE

The EEG recording device will be placed in conjunction with the standard formal polysomnography (PSG). The EEG device will remain in place as long as PSG leads are connected to the subject and PSG machine.

Interventions

2-lead limited electroencephalography recording

The EEG recording device will be placed in conjunction with the standard formal polysomnography (PSG). The EEG device will remain in place as long as PSG leads are connected to the subject and PSG machine.

Intervention Type: DEVICE

Other Intervention Names

Health Subjects in Sleep Lab; ICU patients, not sedated or ventilated; ICU patient, sedated and ventilated

Eligibility Criteria

Inclusion Criteria

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

• Age 18 or older
• Anticipated to stay in intensive care unit overnight (minimum 8 hours)
• Glasgow Coma Scale score of 13 or great

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

Exclusion Criteria

• Patient/Legally Authorized Representative declines consent

Group 2: ICU patient, not sedated, not ventilated

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Epitel, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Joseph Tonna

Associate Director, ECMO Services

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joseph Tonna, MD, FAAEM

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

University of Utah

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

87693

Identifier Type: -

Identifier Source: org_study_id