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EEG Detection of Delirium (VEEGilance)

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ClinicalTrials.gov Identifier: NCT04797052
Recruitment Status : Recruiting
First Posted : March 15, 2021
Last Update Posted : August 18, 2021
Sponsor:
Collaborator:
Transmedtech
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

Study Description
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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) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective observational study
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prefrontal EEG Early Detection of Delirium in Older Adults
Actual Study Start Date : April 5, 2021
Estimated Primary Completion Date : December 18, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Difference of relative power of delta and theta brain waves [ Time Frame: 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 [ Time Frame: up to five days after the operation ]
    Difference between group with and without delirium

  2. describe the presence of artefacts [ Time Frame: up to five days after the operation ]
    Examine the EEG reading for artefacts


Eligibility Criteria
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Ages Eligible for Study:   65 Years to 120 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04797052


Contacts
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Contact: Patrick VQ Nguyen 514-890-8000 ext 36163 patrick.nguyen@umontreal.ca
Contact: Vu Thien Tuong Minh, MD 514-890-8000

Locations
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Canada, Quebec
Centre Hospitalier de l'Université de Montréal Recruiting
Montreal, Quebec, Canada
Contact: Patrick Nguyen    514-890-8000 ext 36163    patrick.nguyen.chum@ssss.gouv.qc.ca   
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Transmedtech
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT04797052    
Other Study ID Numbers: 20.377
First Posted: March 15, 2021    Key Record Dates
Last Update Posted: August 18, 2021
Last Verified: August 2021

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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:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
 Nervous System Diseases
Neurocognitive Disorders
Mental Disorders