NCT04797052

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 15, 2021

Completed
21 days until next milestone

Study Start

First participant enrolled

April 5, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
Last Updated

March 30, 2023

Status Verified

March 1, 2023

Enrollment Period

1.8 years

First QC Date

March 10, 2021

Last Update Submit

March 28, 2023

Conditions

Post Operative Delirium

Keywords

Post operative deliriumOlder AdultsElectroencephalography

Outcome Measures

Primary Outcomes (1)

  • 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 (2)

  • Difference of relative power of beta and alpha brain waves

    up to five days after the operation

  • describe the presence of artefacts

    up to five days after the operation

Study Arms (1)

Post operative patients

EXPERIMENTAL

Post operative patient in orthopedic and digestive surgery

Device: Prefrontal EEG (VEEGix by NeuroServo)

Interventions

Prefrontal EEG (VEEGix by NeuroServo)DEVICE

Prefrontal EEG reading

Post operative patients

Eligibility Criteria

Age65 Years - 120 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • years and older
  • Had a orthopedic or digestive surgery
  • Good undersanding of French or English
  • Consent to participate in the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Prospective observational study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2021

First Posted

March 15, 2021

Study Start

April 5, 2021

Primary Completion

January 30, 2023

Study Completion

January 30, 2023

Last Updated

March 30, 2023

Record last verified: 2023-03

Locations

CA(1)