pEEG Monitoring Effect on Delirium, Ventilator Days, and PICS

Critical Illness Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06019078
• Other study ID #: H23-01671
• Status: Recruiting
• Start date: January 31, 2024
• Est. completion date: January 2026

Study information

• Verified date: March 2024
• Source: Fraser Health
• Contact: Fiona E Howarth
• Phone: 6046143694
• Email: fiona.howarth[@]fraserhealth.ca
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 2026
• Est. primary completion date: January 2025
• Gender: All
• Age group: 17 Years to 110 Years

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia
• Critical Illness
• Delirium
• Mechanical Ventilation Complication
• Post Intensive Care Syndrome
• Post Intensive Care Unit Syndrome
• Syndrome

Intervention

Device:
• SedLine
Continuous 4 channel processed neurological monitor

Locations

Country	Name	City	State
Canada	Abbotsford Regional Hospital	Abbotsford	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Fraser Health	University of Victoria

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	For the time the patient remains in ICU until discharge from ICU. Average length of stay in ICU is 7 days.
Secondary	Days of Mechanical Ventilation	Measured at ICU discharge, measured as half days.	From the date of intubation until extubation in ICU. Average length of mechanical ventilation is 7 days.
Secondary	Sedation Infusions (Propofol and/or Midazolam)	Rates and dosages of sedation infusions	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.
Secondary	Combined Sedation and Analgesia Infusions (Dexmedetomidine and/or Ketamine)	Rates and dosages of sedation and analgesic infusions	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.
Secondary	Analgesia Infusions (Fentanyl, Morphine, and/or Hydromorphone)	Rates and dosages of analgesic infusions	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.
Secondary	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.	At hospital discharge (4 days +/- 1) average length of stay in hospital 5-90 days, 1 month post discharge, 3 months post discharge
Secondary	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.	At hospital discharge (4 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)
Secondary	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.	At hospital discharge (4 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)
Secondary	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.	At hospital discharge (4 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)
Secondary	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.	From the time pEEG monitoring is initiated until it is discontinued. Average length of time spent on a pEEG monitor is 5 days.