Critical IllnessNCT06019078
pEEG Monitoring Effect on Delirium, Ventilator Days, and PICS
An observational study of Critical Illness and Post Intensive Care Unit Syndrome, run by Fraser Health at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 110 years
- Conditions the study is for
- Critical Illness, Post Intensive Care Unit Syndrome, Post Intensive Care Syndrome
- What is being tested?
- SedLine
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 31 Jan 2024to 30 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 110 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult medical and surgical ICU patients .
Who may be able to join
- Admitted to ICU
- Receive mechanical ventilator support during ICU stay
- Require IV sedation or analgesic for a RASS -3 to -5 while ventilated
- Discharged home from the hospital
- Use of pEEG for sedation or analgesic titration
- Able to read and speak English
Show all 10Show fewer
- 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.
Who cannot join
- Deceased during hospitalization
- Intubated at a hospital not using SedLine > 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Abbotsford Regional Hospital
Abbotsford British Columbia, British Columbia, V2S0C2
About this study
Official title: 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.
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?
Read the 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
- Being tested
- SedLine
- Keywords
- criticial illness, post intensive care unit syndrome, post intensive care syndrome, mechanical ventilation complication, delirium
- Medical subject headings
- Critical Illness, postintensive care syndrome, Delirium, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SedLineDevice
Continuous 4 channel processed neurological monitor
| Study group | Role | What they receive |
|---|---|---|
| Prospective Cohort | Patients admitted to participating ICUs who meet inclusion criteria monitored by 4 channel pEEG. Receives: Device: SedLine | |
| Retrospective Cohort | Patients admitted to participating ICUs who meet inclusion criteria not monitored by 4 channel pEEG. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured at ICU discharge, measured as half days.
Measured: From the date of intubation until extubation in ICU. Average length of mechanical ventilation is 7 days.
Sedation Infusions (Propofol and/or Midazolam)
Rates and dosages of sedation infusions
Measured: 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)
Rates and dosages of sedation and analgesic infusions
Measured: 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)
Rates and dosages of analgesic infusions
Measured: 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
CNS Vital Signs (CNSVS) is a computerized neurocognitive test battery that was developed as a routine clinical screening instrument. It is comprised of seven tests: verbal and visual memory, finger tapping, symbol digit coding, the Stroop Test, a test of shifting attention and the continuous performance test. Standard Scores are normalized from raw scores and present an age matched score relative to other people in a normative sample. CNS Vital Signs standardized have a mean of 100 and a standard deviation is 15. Higher scores are always better.
Measured: At hospital discharge (6 days +/- 1) average length of stay in hospital 5-90 days, 1 month post discharge, 3 months post discharge
Hospital Anxiety and Depression Scale
The questionnaire comprises seven questions for anxiety and seven questions for depression. For both scales, scores of less than 7 indicate non-cases, score of 8-10 mild case, 11-14 moderate case, and 15-21 severe case.
Measured: At hospital discharge (6 days +/- 1) average length of stay in hospital 5-90 days, 1 month post discharge (6 days +/- 1) , 3 months post discharge (6 days +/- 1)
Impact of Events Scale-Revised
The IES-R is a validated 22-item self-report scale measuring psychological stress reactions after a major life or traumatic event.1-3Items are rated with reference to the past 7 days on a 5-point scale, ranging from 0 to 4. Three subscale scores are calculated by taking the mean of the item responses: Intrustion (8 items), Avoidance (8 items), and Hyperarousal (6 items). The total score is similarly computed by taking the mean of all 22 items. All scores range from 0 to 4, with higher scores indicating higher event-related distress. Internal consistency estimates(Cronbach's alpha) for all scores range between 0.79 to 0.92.
Measured: At hospital discharge (6 days +/- 1) average length of stay in hospital 5-90 days, 1 month post discharge (6 days +/- 1) , 3 months post discharge (6 days +/- 1)
EuroQol-5D-5L
Health related quality of life questionnaire EuroQol-5D-5L is used. Five levels are score in 5 dimensions. It is scaled from 0 to 100%. A higher score indicates a higher quality of life.
Measured: At hospital discharge (6 days +/- 1) average length of stay in hospital 5-90 days, 1 month post discharge (6 days +/- 1) , 3 months post discharge (6 days +/- 1)
Suppression Ratio
Percentage of time the patient's brain is in burst suppression. Scored on a numerical scale 0-100%. A lower percentage is better.
Measured: From the time pEEG monitoring is initiated until it is discontinued. Average length of time spent on a pEEG monitor is 5 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start31 Jan 2024
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fraser Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of Victoria
- Responsible party
- Sponsor
- Investigators
- Fiona E Howarth, Principal investigator, Fraser Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06019078
- Sponsor's protocol ID
- H23-01671
- Status last verified
- Aug 2025
- First submitted
- 14 Aug 2023
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06019078
- Acronym / sponsor ID
- H23-01671
- Conditions
- Critical Illness, Post Intensive Care Unit Syndrome, Post Intensive Care Syndrome, Mechanical Ventilation Complication, Delirium, Sedative-Related Disorders; Subsequent Encounter
- Keywords
- criticial illness, post intensive care unit syndrome, post intensive care syndrome, mechanical ventilation complication, delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Fraser HealthUniversity, hospital or other
- Collaborators
- University of Victoria
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 31 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective Cohort | – | Device: SedLinePatients admitted to participating ICUs who meet inclusion criteria monitored by 4 channel pEEG. |
| Retrospective Cohort | – | –Patients admitted to participating ICUs who meet inclusion criteria not monitored by 4 channel pEEG. |
Who may qualify
- Ages
- 17 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult medical and surgical ICU patients .
Key inclusion criteria (10 listed)
- Admitted to ICU
- Receive mechanical ventilator support during ICU stay
- Require IV sedation or analgesic for a RASS -3 to -5 while ventilated
- Discharged home from the hospital
- Use of pEEG for sedation or analgesic titration
Key exclusion criteria (6 listed)
- Deceased during hospitalization
- Intubated at a hospital not using SedLine > 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SedLineContinuous 4 channel processed neurological monitor | Device | Prospective Cohort |
Primary outcome
Delirium
Time frame: For the time the patient remains in ICU until discharge from ICU. Average length of stay in ICU is 7 days.
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.
9 secondary outcomes
Days of Mechanical Ventilation
Time frame: From the date of intubation until extubation in ICU. Average length of mechanical ventilation is 7 days.
Sedation Infusions (Propofol and/or Midazolam)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: At hospital discharge (6 days +/- 1) average length of stay in hospital 5-90 days, 1 month post discharge, 3 months post discharge
Hospital Anxiety and Depression Scale
Time frame: At hospital discharge (6 days +/- 1) average length of stay in hospital 5-90 days, 1 month post discharge (6 days +/- 1) , 3 months post discharge (6 days +/- 1)
Impact of Events Scale-Revised
Time frame: At hospital discharge (6 days +/- 1) average length of stay in hospital 5-90 days, 1 month post discharge (6 days +/- 1) , 3 months post discharge (6 days +/- 1)
EuroQol-5D-5L
Time frame: At hospital discharge (6 days +/- 1) average length of stay in hospital 5-90 days, 1 month post discharge (6 days +/- 1) , 3 months post discharge (6 days +/- 1)
Suppression Ratio
Time frame: From the time pEEG monitoring is initiated until it is discontinued. Average length of time spent on a pEEG monitor is 5 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fiona E Howarth principal investigator
Fraser Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Post Intensive Care Unit Syndrome, run by Fraser Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium (time frame: For the time the patient remains in ICU until discharge from ICU. Average length of stay in ICU is 7 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.