pEEG Monitoring Effect on Delirium, Ventilator Days, and PICS

Fraser Health

Status: Completed

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

Treatments: Device: SedLine

Study type: Observational

Funder types: Other

Identifiers

NCT06019078

H23-01671

Details and patient eligibility

About

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?

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 17 to 110 years old

Volunteers: No Healthy Volunteers

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 for the questionnaires and assessment and be able to use computer and internet.

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.

Trial design

150 participants in 2 patient groups

Prospective Cohort

Description:

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

Treatment:

Device: SedLine

Retrospective Cohort

Description:

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