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Pediatric Delirium Screening in the PICU Via EEG (PEDEEGO)

S

St. Justine's Hospital

Status

Unknown

Conditions

Delirium

Treatments

Device: aEEG via vEEGix

Study type

Interventional

Funder types

Other

Identifiers

NCT04846023
HSJ-2021-xxx

Details and patient eligibility

About

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.

Full 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.

Enrollment

220 estimated patients

Sex

All

Ages

Under 18 years old

Volunteers

No 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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

220 participants in 1 patient group

amplitude EEG (aEEG) via VEEGix
Experimental group
Description:
Amplitude-Integrated EEG can be achieved with a limited number of frontal electrodes.
Treatment:
Device: aEEG via vEEGix

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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