Clinical Investigation of an Eye-Tracking Device as a Predictor of Delirium in the Recovery Room After Surgery With General Anesthesia

NCT05579093 | Completed

• 2 other identifiers: AAAT9610IRB00103151
• Study Type: observational
• Target: 325
• Locations: 1 country
• Sites: 1

Brief Summary

Neurotrack™ is an FDA-approved device for measuring and tracking cognitive decline, as may occur with age-related cognitive decline and Alzheimer's disease. The device uses a webcam (World Wide Web enabled camera) to assess eye-tracking as the subject views black-and-white images on the computer screen. The test takes less than 5 minutes to complete. This study will examine the feasibility and utility of pre-operative assessment of cognition using Neurotrack™ technology. The predictive value of Neurotrack™ will be compared to our previous work using pupillometry. The primary outcome is a measure of delirium in the recovery room and secondary outcomes include total length of stay, intensive care unit (ICU) length of stay, and readmissions within 30 days of surgery.

Conditions

Delirium

Keywords

Neurotrack™

Outcome Measures

Primary Outcomes (1)

• Prevalence of delirium

  Prevalence of delirium in in the post anesthesia care unit (PACU) will be calculated.

  Up to 2 years

Interventions

Cognitive test + Pupillary measure COMBINATION_PRODUCT

Patients will be put into a quiet room with a computer and a webcam for a five minute assessment with the NeuroTrack™ testing. Study personnel will stay in the room, and be available for answering questions about using the online testing tool. After Neurotrack, pupillary responses will be recorded with the pupillometer with the PLR -3000TM. In brief, an eye cup attached to a pupillometer will be placed over one eye to allow measurement of the pupillary response to light. Once the eye cup is properly positioned, the reading takes approximately 5 seconds, after which time the eye cup will be removed. The reading will then be taken in the contralateral eye.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Sign-up for the protocol will be based upon a review of the preoperative and pre-op clinic schedules, a recommendation from operating room physicians or referral from preoperative anesthesia consultant at the conclusion of their preoperative clinic visit. A clinical research coordinator or other research personnel is available to answer questions and obtain informed consent from the patient. It will be made clear to the patient that study participation is optional and that they can "opt out" at any time even if they have signed a consent form. We intend on enrolling male and female patients that meet eligibility criteria.

You may qualify if:

• Age 18 years or greater
• Any American Society of Anesthesiologists (ASA) classification
• Scheduled elective surgery with general anesthesia. Extubation, and emergence anticipated in the operating room and recovery in the post-operative care unit (PACU).

You may not qualify if:

• Cardiac surgery (on or off cardiopulmonary bypass).
• Intracranial neurosurgery
• Surgery involving the eye, eyebrow, forehead, or frontal scalp near the eyes
• Emergency surgery
• Monitored Anesthesia Care (i.e., regional anesthesia alone without anticipated plans for general anesthesia)
• Poor health literacy ("How confident are you filling out medical forms by yourself?")
• Endotracheal intubation maintained upon leaving operating room
• Direct admission to ICU due to foreseen or unforeseen circumstances

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Delirium

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Paul S. Garcia, MD, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: October 13, 2022
• Study Start: October 1, 2019
• Primary Completion: September 20, 2021
• Study Completion: September 20, 2021
• Last Updated: May 24, 2023

Record last verified: 2023-05

Locations

US (1)