VEEGilance: EEG Detection of Delirium

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04797052
• Collaborator: Transmedtech (Other)
• Enrollment: 160
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 14.8
• Patients Per Site Per Month: 10.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Post Operative Delirium	Device: Prefrontal EEG (VEEGix by NeuroServo)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 160 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Prospective observational studyProspective observational study
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Prefrontal EEG Early Detection of Delirium in Older Adults
• Actual Study Start Date: Apr 5, 2021
• Anticipated Primary Completion Date: Dec 18, 2021
• Anticipated Study Completion Date: Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Post operative patients Post operative patient in orthopedic and digestive surgery	Device: Prefrontal EEG (VEEGix by NeuroServo); Prefrontal EEG reading

Outcome Measures

Primary Outcome Measures

1. Difference of relative power of delta and theta brain waves [up to five days after the operation]

   Difference between group with and without delirium

Secondary Outcome Measures

1. Difference of relative power of beta and alpha brain waves [up to five days after the operation]

   Difference between group with and without delirium

2. describe the presence of artefacts [up to five days after the operation]

   Examine the EEG reading for artefacts

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years to 120 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier de l'Université de Montréal	Montreal	Quebec	Canada

Sponsors and Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM)
• Transmedtech

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
• ClinicalTrials.gov Identifier: NCT04797052
• Other Study ID Numbers: 20.377
• First Posted: Mar 15, 2021
• Last Update Posted: Aug 18, 2021
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM): Post operative delirium; Older Adults; Electroencephalography
• Additional relevant MeSH terms: Delirium

Study Results

No Results Posted as of Aug 18, 2021