DeliriumPEDEEGONCT04846023
Pediatric Delirium Screening in the PICU Via EEG
A study testing aEEG via vEEGix in people with Delirium, run by St. Justine's Hospital.
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. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Delirium
- What is being tested?
- aEEG via vEEGix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- Sep 2021to Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
Read the 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.
- Conditions
- Delirium
- Being tested
- aEEG via vEEGix
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aEEG via vEEGixDevice
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
| Study group | Role | What they receive |
|---|---|---|
| amplitude EEG (aEEG) via VEEGix | Experimental | Amplitude-Integrated EEG can be achieved with a limited number of frontal electrodes. Receives: Device: aEEG via vEEGix |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year recruitment
Secondary outcomes (1)
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).
Measured: 1 year recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study startSep 2021 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single center prospective interventional study of children admitted to a PICU
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laurence Ducharme-Crevier, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04846023
- Sponsor's protocol ID
- HSJ-2021-xxx
- Acronym
- PEDEEGO
- Status last verified
- Apr 2021
- First submitted
- 1 Apr 2021
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Delirium Screening in the PICU Via EEG
- ClinicalTrials.gov ID
- NCT04846023
- Acronym / sponsor ID
- PEDEEGO / HSJ-2021-xxx
- Conditions
- Delirium
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 15 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single center prospective interventional study of children admitted to a PICU
| Arm | Type | Receives |
|---|---|---|
| amplitude EEG (aEEG) via VEEGix | Experimental | Device: aEEG via vEEGixAmplitude-Integrated EEG can be achieved with a limited number of frontal electrodes. |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aEEG via vEEGixAmplitude-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 | Device | amplitude EEG (aEEG) via VEEGix |
Primary outcome
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.
1 secondary outcome
To investigate the accuracy and rapidity of delirium diagnosis with the VEEGix.
Time frame: 1 year recruitment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing aEEG via vEEGix in people with Delirium, run by St. Justine's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2021.