Pediatric Delirium Screening in the PICU Via EEG (PEDEEGO)

Delirium in the pediatric intensive care unit (PICU) is a serious problem that has recently attracted much attention. This study will evaluate the use of electroencephalogram (EEG) for delirium screening in the PICU.

Study Overview

• Status: Not yet recruiting
• Conditions: Delirium
• Intervention / Treatment: Device: aEEG via vEEGix

Detailed Description

Primary objective: In a prospective cohort of children hospitalized in a PICU, EEG features associated with pediatric delirium (via VEEGix) will be identified and the diagnostic value to accurately detect delirium of these features will be calculated.

Secondary objective: To investigate the accuracy and rapidity of delirium diagnosis with the VEEGix.

• Study Type: Interventional
• Enrollment (Anticipated): 220
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Eligible for inclusion children 1) <18 years; and 2) admitted to the PICU at the Centre Hospitalier Universitaire Ste-Justine (CHUSJ). To select patients at high risk for delirium, one of the following inclusion criteria will be needed: 3) mechanically ventilated patients; or 4) non-invasively ventilated patients (BiPap, Cpap or high flow nasal cannula); or 5) patients receiving opioids; or 6) patients receiving benzodiazepines.

Exclusion Criteria:

Children 1) suspected of being brain death at the time of PICU entry (Glasgow Coma Scale (GCS) 3 and loss of all brain stem reflexes); 2) with significant clinical developmental delay (based on clinical assessment and/or parental report of developmental problems that affected the child's behavior or ability to communicate; Pediatric Cerebral Performance Category ≥4); 3) planned discharge from the PICU the same or next day.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: amplitude EEG (aEEG) via VEEGix; Amplitude-Integrated EEG can be achieved with a limited number of frontal electrodes.

Device: aEEG via vEEGix; Amplitude-Integrated EEG can be achieved with a limited number of frontal electrodes. There is a new aEEG technology available: VEEGix, developed by NeuroServo Inc. It is a miniaturized aEEG, non-intrusive, portable and resistant to patient's movements. Its main advantage is its simplicity of use as a single adhesive strip including all electrodes is fixed to the patient's forehead and is connected to the VEEGix device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In a prospective cohort of children hospitalized in a PICU, the EEG features associated with pediatric delirium (via VEEGix) willl be identified.	Variables will include 1) predominant background frequencies: delta 0-3.9 Hz, theta 4-7.9 Hz, alpha 8-11.9 Hz and beta 12-30 Hz and power spectrum (ratio of each frequency/total 0-30Hz), 2) EEG: symmetry (symmetric, mild asymmetry, marked asymmetry) and prevalence (continuous, nearly continuous (1-9% of suppression or attenuation), discontinuous (10-49% of suppression or attenuation), burst suppression or burst-attenuation (50-99% of suppression or attenuation), suppression (>99% of suppression or attenuation) as measured by percentage per hour of recording)(19). As power across all frequency bands decreases significantly with age, children will be divided 0 to 6 months, 6 months to 3 years and 3-18 years old.	1 year recruitment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To investigate the accuracy and rapidity of delirium diagnosis with the VEEGix.	The diagnosis of delirium by the vEEGix will be defined as presence of EEG characteristics of delirium (identified in objective 1). Diagnosis of delirium by the vEEGix will be compared to the diagnosis of delirium by the medical team (confirmed by a adjudicating committee). Timing of delirium diagnosis will be compared: diagnosis by the medical team (defined as the first CAPD scores equal or greater than 9) versus diagnosis by the vEEGix (the beginning of the delirium episode will be defined as the appearance of these EEG characteristics).	1 year recruitment

Collaborators and Investigators

• Sponsor: St. Justine's Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: April 1, 2021
• First Submitted That Met QC Criteria: April 12, 2021
• First Posted (Actual): April 15, 2021

Study Record Updates

• Last Update Posted (Actual): April 15, 2021
• Last Update Submitted That Met QC Criteria: April 12, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: HSJ-2021-xxx

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No