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Clinical Trials/NCT04846023
NCT04846023
Unknown
Not Applicable

Pediatric Delirium Screening in the PICU Via EEG

St. Justine's Hospital0 sites220 target enrollmentSeptember 2021
ConditionsDelirium

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Delirium
Sponsor
St. Justine's Hospital
Enrollment
220
Primary Endpoint
In a prospective cohort of children hospitalized in a PICU, the EEG features associated with pediatric delirium (via VEEGix) willl be identified.
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2021
End Date
September 2023
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
St. Justine's Hospital
Responsible Party
Principal Investigator
Principal Investigator

Laurence Ducharme-Crevier

Pediatric intensivist, Principal Investigator

St. Justine's Hospital

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.

Outcomes

Primary Outcomes

In a prospective cohort of children hospitalized in a PICU, the EEG features associated with pediatric delirium (via VEEGix) willl be identified.

Time Frame: 1 year recruitment

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 Outcomes

  • To investigate the accuracy and rapidity of delirium diagnosis with the VEEGix.(1 year recruitment)

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