Pediatric Delirium Screening in the PICU Via EEG

NCT04846023 | Unknown

• 1 other identifier: HSJ-2021-xxx
• Study Type: interventional
• Target: 220
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Delirium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To investigate the accuracy and rapidity of delirium diagnosis with the VEEGix.

  1 year recruitment

Study Arms (1)

amplitude EEG (aEEG) via VEEGix

EXPERIMENTAL

Amplitude-Integrated EEG can be achieved with a limited number of frontal electrodes.

Device: aEEG via vEEGix

Interventions

aEEG via vEEGix DEVICE

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

amplitude EEG (aEEG) via VEEGix

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Justine's Hospital: lead

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric intensivist, Principal Investigator

Model Details: Single center prospective interventional study of children admitted to a PICU

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 15, 2021
• Study Start: September 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2023
• Last Updated: April 15, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share