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OpenTrials
Completed

NCT Number: NCT04797052

EEG Detection of Delirium

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.

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Key information

Conditions

Post Operative Delirium Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

65 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prefrontal EEG (VEEGix by NeuroServo)

Device

Prefrontal EEG reading

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Collaborators

  • TransMedTech Institute

Registry information

Official study title

Prefrontal EEG Early Detection of Delirium in Older Adults

Acronym: VEEGilance

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 15, 2021
Registry last updated
Mar 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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