Pediatric Delirium Screening in the PICU Via EEG

Delirium Clinical Trial

— PEDEEGO  

Official title:

Pediatric Delirium Screening in the PICU Via EEG

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04846023
• Other study ID #: HSJ-2021-xxx
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2021
• Est. completion date: September 2023

Study information

• Verified date: April 2021
• Source: St. Justine's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 220
• Est. completion date: September 2023
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Delirium

Intervention

Device:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
St. Justine's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	1 year recruitment