EEG Detection of Delirium | NCT04797052

Studies
EEG Detection of Delirium

NCT04797052

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Status

Completed

Last Update Posted

Mar 30, 2023Actual

Enrollment

234Actual

Phase

Not Applicable

Conditions

Post Operative Delirium

Interventions

Prefrontal EEG (VEEGix by NeuroServo)

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 5, 2021Actual

Primary Completion Date

Jan 30, 2023Actual

Completion Date

Jan 30, 2023Actual

First Submitted Date

Mar 10, 2021

First Submission Date that Met QC Criteria

Mar 12, 2021

First Posted Date

Mar 15, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2023

Last Update Posted Date

Mar 30, 2023Actual

Name	Class
TransMedTech Institute	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

234Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Post operative patients	Experimental	Post operative patient in orthopedic and digestive surgery	Device: Prefrontal EEG (VEEGix by NeuroServo)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prefrontal EEG (VEEGix by NeuroServo)	Device	Prefrontal EEG reading	Post operative patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Difference of relative power of beta and alpha brain waves	Difference between group with and without delirium	up to five days after the operation
describe the presence of artefacts	Examine the EEG reading for artefacts

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

120 Years

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier de l'Université de Montréal		Montreal	Quebec		Canada

Condition Browse Module

MeSH Terms

ID	Term
D000071257	Emergence Delirium

Ancestor Terms

ID	Term
D003693	Delirium
D003221	Confusion
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided