pEEG Monitoring Effect on Delirium, Ventilator Days, and PICS
NCT06019078, Completed, Fraser Health
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | pEEG Monitoring Effect on Delirium, Ventilator Days, and PICS | ClinicalTrials.gov |
| NCT number | NCT06019078 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Enrollment | 150 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Fraser Health | ClinicalTrials.gov |
| Conditions | Critical Illness, Post Intensive Care Unit Syndrome, Post Intensive Care Syndrome, Mechanical Ventilation Complication, Delirium, Sedative-Related Disorders; Subsequent Encounter, Analgesia | ClinicalTrials.gov |
| Interventions | SedLine | ClinicalTrials.gov |
| First posted | 2023-08-31 | ClinicalTrials.gov |
| Last updated | 2026-09-21 | ClinicalTrials.gov |
Registered outcomes 10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Delirium | 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. | ClinicalTrials.gov |
| Secondary | Days of Mechanical Ventilation | From the date of intubation until extubation in ICU. Average length of mechanical ventilation is 7 days. | Measured at ICU discharge, measured as half days. | ClinicalTrials.gov |
| Secondary | Sedation Infusions (Propofol and/or Midazolam) | 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. | Rates and dosages of sedation infusions | ClinicalTrials.gov |
| Secondary | Combined Sedation and Analgesia Infusions (Dexmedetomidine and/or Ketamine) | 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. | Rates and dosages of sedation and analgesic infusions | ClinicalTrials.gov |
| Secondary | Analgesia Infusions (Fentanyl, Morphine, and/or Hydromorphone) | 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. | Rates and dosages of analgesic infusions | ClinicalTrials.gov |
| Secondary | Computerized Neurocognitive Screening Vital Signs | At hospital discharge (6 days +/- 1) average length of stay in hospital 5-90 days, 1 month post discharge, 3 months post discharge | 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. | ClinicalTrials.gov |
| Secondary | Hospital Anxiety and Depression Scale | 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) | 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. | ClinicalTrials.gov |
| Secondary | Impact of Events Scale-Revised | 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) | 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. | ClinicalTrials.gov |
| Secondary | EuroQol-5D-5L | 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) | 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. | ClinicalTrials.gov |
| Secondary | Suppression Ratio | From the time pEEG monitoring is initiated until it is discontinued. Average length of time spent on a pEEG monitor is 5 days. | Percentage of time the patient's brain is in burst suppression. Scored on a numerical scale 0-100%. A lower percentage is better. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Continuous Performance Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)