EEG Detection of Delirium

Post Operative Delirium Clinical Trial

— VEEGilance  

Official title:

Prefrontal EEG Early Detection of Delirium in Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04797052
• Other study ID #: 20.377
• Status: Completed
• Phase: N/A
• Start date: April 5, 2021
• Est. completion date: January 30, 2023

Study information

• Verified date: March 2023
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: January 30, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 120 Years

Eligibility

Inclusion Criteria:

• 65 years and older

• Had a orthopedic or digestive surgery

• Good undersanding of French or English

• Consent to participate in the study

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Delirium
• Post Operative Delirium

Intervention

Device:
• Prefrontal EEG (VEEGix by NeuroServo)
Prefrontal EEG reading

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Université de Montréal	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)	TransMedTech Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference of relative power of delta and theta brain waves	Difference between group with and without delirium	up to five days after the operation
Secondary	Difference of relative power of beta and alpha brain waves	Difference between group with and without delirium	up to five days after the operation
Secondary	describe the presence of artefacts	Examine the EEG reading for artefacts	up to five days after the operation