Pediatric Delirium Screening in the PICU Via EEG

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-30

Study Completion Date

2023-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Delirium

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single center prospective interventional study of children admitted to a PICU

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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amplitude EEG (aEEG) via VEEGix

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

Group Type EXPERIMENTAL

aEEG via vEEGix

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

0 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No