pEEG Monitoring Effect on Delirium, Ventilator Days, and PICS

Last updated: March 8, 2024
Sponsor: Fraser Health
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pain

Dementia

Treatment

SedLine

Clinical Study ID

NCT06019078
H23-01671
  • Ages 17-110
  • All Genders

Study 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?

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: SedLine
Phase:
Study Start date:
January 31, 2024
Estimated Completion Date:
January 31, 2026

Study 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.

Connect with a study center

  • Abbotsford Regional Hospital

    Abbotsford, British Columbia V2S0C2
    Canada

    Active - Recruiting

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