pEEG Monitoring Effect on Delirium, Ventilator Days, and PICS

NCT06019078 | Completed

• 1 other identifier: H23-01671
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this multi-site observational study is to compare delirium rates, days on mechanical ventilation, and Post Intensive Care Syndrome (PICS) rates in adult Intensive Care Unit (ICU) patients. The study will examine patients whose sedation and analgesia infusion titration is managed with both Richmond Agitation and Sedation Scale (RASS) and Processed Electroencephalography (pEEG) monitoring vs patients who receive RASS monitoring alone. The main questions are:

• Compared to RASS monitoring method alone, does the use of 4 channel pEEG monitor in conjunction with RASS to guide the management of sedation and analgesic in patients who are ventilated reduce the average number of delirium days, measured by Intensive Care Delirium Screening Checklist (ICDSC)?
• To determine when compared to RASS monitoring alone if the use of 4 channel pEEG monitor in conjunction with RASS to guide the management of Intravenous (IV) sedation and analgesia in ventilated patients reduces the days a patient spends on a mechanical ventilator when compared to RASS only monitoring from retrospective data.
• To determine when compared to RASS monitoring method alone, does the use of 4 channel pEEG monitor in conjunction with RASS experience lower doses of sedation and analgesia infusions?
• To determine when compared to RASS monitoring method alone, does the use of 4 channel pEEG monitor in conjunction with RASS experience less incidence and duration of PICS?

Conditions

Mechanical Ventilation Complication; Delirium; Sedative-Related Disorders; Subsequent Encounter; Analgesia; Critical Illness; Post Intensive Care Unit Syndrome; Post Intensive Care Syndrome

Keywords

criticial illness; post intensive care unit syndrome; post intensive care syndrome; mechanical ventilation complication; delirium

Outcome Measures

Primary Outcomes (1)

• Delirium

  Measured by Intensive Care Delirium Screening Checklist (ICDSC). The items include the assessment of: (1) consciousness ( deep sedation/coma, agitation, normal wakefulness, or light sedation); (2) inattention; (3) disorientation; (4) hallucination, delusion, or psychosis; (5) psychomotor agitation or retardation; (6) inappropriate speech or mood; (7) sleep-wake cycle disturbances; and (8) fluctuation of symptomatology. The maximum score is eight; scores of ≥4 indicate the presence of delirium and score zero is indicate not in delirium. Each item is scored 0-8.

  For the time the patient remains in ICU until discharge from ICU. Average length of stay in ICU is 7 days.

Secondary Outcomes (9)

• Days of Mechanical Ventilation

  From the date of intubation until extubation in ICU. Average length of mechanical ventilation is 7 days.

• Sedation Infusions (Propofol and/or Midazolam)

  Measured every 4 hours while the patient remains on the infusion in ICU. Average length of time spent on a sedation infusion is 5 days.

• Combined Sedation and Analgesia Infusions (Dexmedetomidine and/or Ketamine)

  Measured every 4 hours while the patient remains on the infusion in ICU. Average length of time spent on a combined sedation and analgesic infusion is 3 days.

• Analgesia Infusions (Fentanyl, Morphine, and/or Hydromorphone)

  Measured every 4 hours while the patient remains on the infusion in ICU. Average length of time spent on an analgesic infusion is 5 days.

• Computerized Neurocognitive Screening Vital Signs

  At hospital discharge (4 days +/- 1) average length of stay in hospital 5-90 days, 1 month post discharge, 3 months post discharge

Study Arms (2)

Prospective Cohort

Patients admitted to participating ICUs who meet inclusion criteria monitored by 4 channel pEEG.

Device: SedLine

Retrospective Cohort

Patients admitted to participating ICUs who meet inclusion criteria not monitored by 4 channel pEEG.

Interventions

SedLine DEVICE

Continuous 4 channel processed neurological monitor

Prospective Cohort

Eligibility Criteria

• Age: 17 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult medical and surgical ICU patients .

You may qualify if:

• Admitted to ICU
• Receive mechanical ventilator support during ICU stay
• Require IV sedation or analgesic while ventilated
• Discharged home from the hospital
• Use of pEEG for sedation or analgesic titration
• Able to read and speak English
• Mechanically ventilated greater than 48 hours
• Aged 17 years +1 day or greater
• Consent to participate
• Participants need a computer with a keyboard, internet access, and email access for the questionnaires and assessment and be able to use computer and internet.

You may not qualify if:

• Deceased during hospitalization
• Intubated at a hospital not included within the study \> 12 hours
• Discharge to rehabilitation facility, long term care, or other outpatient setting
• Inability to provide informed consent
• Currently enrolled in any other research study involving drugs or devices
• Is unable to be screened for delirium during ICU admission.

Sponsors & Collaborators

• Fraser Health: lead
• University of Victoria: collaborator

Study Sites (1)

Abbotsford Regional Hospital

Abbotsford British Columbia, British Columbia, V2S0C2, Canada

Location

MeSH Terms

Conditions

Critical Illness; postintensive care syndrome; Delirium; Agnosia

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Perceptual Disorders

Study Officials

• Fiona E Howarth

  Fraser Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 31, 2023
• Study Start: January 31, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: February 4, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)