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Pediatric Delirium Screening in the PICU Via EEG (PEDEEGO)

Primary Purpose

Delirium

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
aEEG via vEEGix
Sponsored by
St. Justine's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Delirium

Eligibility Criteria

0 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    amplitude EEG (aEEG) via VEEGix

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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).

    Full Information

    First Posted
    April 1, 2021
    Last Updated
    April 12, 2021
    Sponsor
    St. Justine's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04846023
    Brief Title
    Pediatric Delirium Screening in the PICU Via EEG
    Acronym
    PEDEEGO
    Official Title
    Pediatric Delirium Screening in the PICU Via EEG
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2021 (Anticipated)
    Primary Completion Date
    September 2022 (Anticipated)
    Study Completion Date
    September 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    St. Justine's Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Delirium

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Single center prospective interventional study of children admitted to a PICU
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    220 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    amplitude EEG (aEEG) via VEEGix
    Arm Type
    Experimental
    Arm Description
    Amplitude-Integrated EEG can be achieved with a limited number of frontal electrodes.
    Intervention Type
    Device
    Intervention Name(s)
    aEEG via vEEGix
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    In a prospective cohort of children hospitalized in a PICU, the EEG features associated with pediatric delirium (via VEEGix) willl be identified.
    Description
    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.
    Time Frame
    1 year recruitment
    Secondary Outcome Measure Information:
    Title
    To investigate the accuracy and rapidity of delirium diagnosis with the VEEGix.
    Description
    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).
    Time Frame
    1 year recruitment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    0 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Pediatric Delirium Screening in the PICU Via EEG

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