Clinical trial NCT06019078: pEEG Monitoring Effect on Delirium, Ventilator Days, and PICS
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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Critical Illness
Post Intensive Care Unit Syndrome
Post Intensive Care Syndrome
Mechanical Ventilation Complication
Delirium
Sedative-Related Disorders; Subsequent Encounter
Analgesia
Keywords: criticial illness
post intensive care unit syndrome
post intensive care syndrome
mechanical ventilation complication
delirium
Lead sponsor: Fraser Health
Sponsor class: OTHER
Collaborators: name: University of Victoria
First posted: 2023-08-31
Enrollment: 150
Sex: ALL
Minimum age (years): 17
Maximum age (years): 110
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult medical and surgical ICU patients .

Brief 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?

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Delirium
timeFrame: For the time the patient remains in ICU until discharge from ICU. Average length of stay in ICU is 7 days.
Secondary outcomes:
measure: Days of Mechanical Ventilation
timeFrame: From the date of intubation until extubation in ICU. Average length of mechanical ventilation is 7 days.
measure: Sedation Infusions (Propofol and/or Midazolam)
timeFrame: 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.
measure: Combined Sedation and Analgesia Infusions (Dexmedetomidine and/or Ketamine)
timeFrame: 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.
measure: Analgesia Infusions (Fentanyl, Morphine, and/or Hydromorphone)
timeFrame: 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.
measure: Computerized Neurocognitive Screening Vital Signs
timeFrame: At hospital discharge (4 days +/- 1) average length of stay in hospital 5-90 days, 1 month post discharge, 3 months post discharge
measure: Hospital Anxiety and Depression Scale
timeFrame: 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)
measure: Impact of Events Scale-Revised
timeFrame: 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)
measure: EuroQol-5D-5L
timeFrame: 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)
measure: Suppression Ratio
timeFrame: From the time pEEG monitoring is initiated until it is discontinued. Average length of time spent on a pEEG monitor is 5 days.
Other outcomes:
Locations:
city: Abbotsford
country: Canada
facility: Abbotsford Regional Hospital
state: British Columbia
Study officials:
affiliation: Fraser Health
name: Fiona E Howarth
role: PRINCIPAL_INVESTIGATOR
References: