Post Operative DeliriumVEEGilanceNCT04797052
EEG Detection of Delirium
A study testing Prefrontal EEG (VEEGix by NeuroServo) in people with Post Operative Delirium, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
VEEGix is a portable device developed by NeuroServo for simplifying electroencephalograms at the bedside. It is an easy-to-use device that only requires the operator to place an adhesive strip of electrodes on the patient's forehead, connected to the device. Read more about this study
- Who is it for?
- Ages 65 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Delirium
- What is being tested?
- Prefrontal EEG (VEEGix by NeuroServo)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteCanada
- Study dates
- 5 Apr 2021to 30 Jan 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 65 to 120 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65 years and older
- Had a orthopedic or digestive surgery
- Good undersanding of French or English
- Consent to participate in the study
Who cannot join
- History of seizure or epilepsia
- Structural brain damage
- intelectual deiciency
- Severe major neurocognitive disorder
- incapacity to respond to the questionnaire
- Hospitalised in intensive care or intubated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prefrontal EEG Early Detection of Delirium in Older Adults
VEEGix is a portable device developed by NeuroServo for simplifying electroencephalograms at the bedside. It is an easy-to-use device that only requires the operator to place an adhesive strip of electrodes on the patient's forehead, connected to the device. The goal of this study is to determine EEG thresholds for the diagnostic of delirium.
Methods : This prospective observational study includes patients undergoing orthopedic or degestive surgery. Each subject will have an EEG reading before surgery and twice daily after surgery until discharge or up to 5 days. Patients will be monitored for post operative delirium using the 3D-Confusion Assessment Method. Delirium diagnostic will be confirmed by a geriatrician. EEG relative power reading will be compared between patient with and without a delirium diagnostic.
- Conditions
- Post Operative Delirium
- Being tested
- Prefrontal EEG (VEEGix by NeuroServo)
- Keywords
- Post operative delirium, Older Adults, Electroencephalography
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prefrontal EEG (VEEGix by NeuroServo)Device
Prefrontal EEG reading
| Study group | Role | What they receive |
|---|---|---|
| Post operative patients | Experimental | Post operative patient in orthopedic and digestive surgery Receives: Device: Prefrontal EEG (VEEGix by NeuroServo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of relative power of delta and theta brain waves
Difference between group with and without delirium
Measured: up to five days after the operation
Secondary outcomes (2)
Difference of relative power of beta and alpha brain waves
Difference between group with and without delirium
Measured: up to five days after the operation
describe the presence of artefacts
Examine the EEG reading for artefacts
Measured: up to five days after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start5 Apr 2021
- Primary completion30 Jan 2023
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative DeliriumStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- 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
- Prospective observational study
- Masking
- None (open label)
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- TransMedTech Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04797052
- Sponsor's protocol ID
- 20.377
- Acronym
- VEEGilance
- Status last verified
- Mar 2023
- First submitted
- 10 Mar 2021
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prefrontal EEG Early Detection of Delirium in Older Adults
- ClinicalTrials.gov ID
- NCT04797052
- Acronym / sponsor ID
- VEEGilance / 20.377
- Conditions
- Post Operative Delirium
- Keywords
- Post operative delirium, Older Adults, Electroencephalography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- TransMedTech Institute
- Study start
- 5 Apr 2021 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 15 Mar 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.
VEEGix is a portable device developed by NeuroServo for simplifying electroencephalograms at the bedside. It is an easy-to-use device that only requires the operator to place an adhesive strip of electrodes on the patient's forehead, connected to the device. The goal of this study is to determine EEG thresholds for the diagnostic of delirium.
Methods : This prospective observational study includes patients undergoing orthopedic or degestive surgery. Each subject will have an EEG reading before surgery and twice daily after surgery until discharge or up to 5 days. Patients will be monitored for post operative delirium using the 3D-Confusion Assessment Method. Delirium diagnostic will be confirmed by a geriatrician. EEG relative power reading will be compared between patient with and without a delirium diagnostic.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective observational study
| Arm | Type | Receives |
|---|---|---|
| Post operative patients | Experimental | Device: Prefrontal EEG (VEEGix by NeuroServo)Post operative patient in orthopedic and digestive surgery |
Who may qualify
- Ages
- 65 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 65 years and older
- Had a orthopedic or digestive surgery
- Good undersanding of French or English
- Consent to participate in the study
Key exclusion criteria (6 listed)
- History of seizure or epilepsia
- Structural brain damage
- intelectual deiciency
- Severe major neurocognitive disorder
- incapacity to respond to the questionnaire
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 |
|---|---|---|
| Prefrontal EEG (VEEGix by NeuroServo)Prefrontal EEG reading | Device | Post operative patients |
Primary outcome
Difference of relative power of delta and theta brain waves
Time frame: up to five days after the operation
Difference between group with and without delirium
2 secondary outcomes
Difference of relative power of beta and alpha brain waves
Time frame: up to five days after the operation
describe the presence of artefacts
Time frame: up to five days after the operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
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The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
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Lactium Premedication to Prevent Emergence Agitation
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prefrontal EEG (VEEGix by NeuroServo) in people with Post Operative Delirium, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Difference of relative power of delta and theta brain waves (time frame: up to five days after the operation). 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 30 Mar 2023.