NCT06019078

pEEG Monitoring Effect on Delirium, Ventilator Days, and PICS

Continuous Processed Neurological Monitor to Guide the Management of Sedation for Patients Receiving Mechanical Ventilation: a Prospective Observational Study to Test the Effects on Delirium, Days on a Ventilator, and Post-Intensive Care Syndrome.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 150 (actual)
• Sponsor: Fraser Health · Academic / Other
• Sex: All
• Age: 17 Years – 110 Years
• Healthy volunteers: Not accepted

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?

Detailed description

The purpose of this study is to determine the impact of using a 4 channel pEEG monitor to guide sedation and analgesia management in conjunction with RASS in ventilated patients in the ICU on length of time patients experience delirium, number of days patients spend on a ventilator, and incidence of PICS in these same patients. Participants who are on a mechanical ventilator and on IV sedation or analgesia will be placed on a pEEG monitor on admission to ICU. Participants will complete a battery of test at discharge, one month post discharge, and three months post discharge to assess for PICS.

Conditions

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

Interventions

Type	Name	Description
DEVICE	SedLine	Continuous 4 channel processed neurological monitor

Timeline

• Start date: 2024-01-31
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2023-08-31
• Last updated: 2026-02-04

Locations

1 site across 1 country: Canada