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EEG Detection of Delirium (VEEGilance)

Primary Purpose

Post Operative Delirium

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Prefrontal EEG (VEEGix by NeuroServo)
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Post Operative Delirium focused on measuring Post operative delirium, Older Adults, Electroencephalography

Eligibility Criteria

65 Years - 120 Years (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Centre Hospitalier de l'Université de Montréal

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Post operative patients

Arm Description

Post operative patient in orthopedic and digestive surgery

Outcomes

Primary Outcome Measures

Difference of relative power of delta and theta brain waves
Difference between group with and without delirium

Secondary Outcome Measures

Difference of relative power of beta and alpha brain waves
Difference between group with and without delirium
describe the presence of artefacts
Examine the EEG reading for artefacts

Full Information

First Posted
March 10, 2021
Last Updated
March 28, 2023
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
TransMedTech Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04797052
Brief Title
EEG Detection of Delirium
Acronym
VEEGilance
Official Title
Prefrontal EEG Early Detection of Delirium in Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 5, 2021 (Actual)
Primary Completion Date
January 30, 2023 (Actual)
Study Completion Date
January 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
TransMedTech Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Delirium
Keywords
Post operative delirium, Older Adults, Electroencephalography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective observational study
Masking
None (Open Label)
Allocation
N/A
Enrollment
234 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Post operative patients
Arm Type
Experimental
Arm Description
Post operative patient in orthopedic and digestive surgery
Intervention Type
Device
Intervention Name(s)
Prefrontal EEG (VEEGix by NeuroServo)
Intervention Description
Prefrontal EEG reading
Primary Outcome Measure Information:
Title
Difference of relative power of delta and theta brain waves
Description
Difference between group with and without delirium
Time Frame
up to five days after the operation
Secondary Outcome Measure Information:
Title
Difference of relative power of beta and alpha brain waves
Description
Difference between group with and without delirium
Time Frame
up to five days after the operation
Title
describe the presence of artefacts
Description
Examine the EEG reading for artefacts
Time Frame
up to five days after the operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Centre Hospitalier de l'Université de Montréal
City
Montreal
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

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EEG Detection of Delirium

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