pEEG Monitoring Effect on Delirium, Ventilator Days, and PICS (NCT06019078) | Clinical Trial Compass
CompletedNot Applicable
pEEG Monitoring Effect on Delirium, Ventilator Days, and PICS
Canada150 participantsStarted 2024-01-31
Plain-language 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?
Who can participate
Age range
17 Years – 110 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used processed EEG monitoring to try to reduce delirium in ICU patients on mechanical ventilation — if I end up in the ICU on a ventilator, is this kind of brain-activity monitoring something my care team already uses, or would it be considered a newer approach?
2The study looked at Post Intensive Care Syndrome, or PICS, as part of what it was measuring — can you explain what PICS is and how likely I or my family member might experience it after a serious ICU stay?
3Since this trial has already been completed, have the results been published yet, and if so, did the EEG-guided sedation approach actually show a meaningful reduction in delirium compared to standard care?
4The trial involved managing sedation and analgesia based on brain monitoring signals — how does the sedation approach used in this study compare to what your hospital or ICU team currently does for patients on ventilators?
5Delirium in the ICU can have serious long-term effects — based on what this trial was studying, are there steps we should be planning for now to reduce the risk of delirium and cognitive problems if an ICU stay becomes necessary?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Delirium
Timeframe: For the time the patient remains in ICU until discharge from ICU. Average length of stay in ICU is 7 days.