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

May 23, 2023 updated by: Columbia University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

How the brain restores baseline consciousness at the end of a perioperative anesthetic is not known. However, it is becoming increasingly evident that arousal after sleep, coma, or anesthesia is an active process, not a passive process relying on simple clearance of anesthetic drugs. Insight into the specific sequence of brain circuit activation and inactivation during the end of an anesthetic may not only lead to an understanding of anesthetic emergence but provide important information for the potential long-term consequences of anesthetic drugs (anesthetic neurotoxicity, and the role of anesthetic drugs in delirium and dementia). The possibility of anesthesia causing harm to the brains of our patients is a controversy that has received a lot of attention from anesthesiologists, surgeons, and patients alike. The investigators' approach is to determine if techniques based on eye movements and/or pupillometry can predict and guide the post anesthesia management of delirium.

The conventional pupillary exam involves assessment of pupil size, shape, symmetry, and reactivity to light. Mechanistically, the pupillary light reflex involves the retina, cranial nerve II and III, pretectal nucleus in the midbrain, Edinger-Westphal nuclei, and the ciliary ganglion. With the use of an automated pupillometer, the pupillary response to light can also be quantified with measures of maximal diameter, latency, constriction velocity, minimal diameter, and dilation velocity. Beyond the reliability and accuracy that the device affords, pupillometry may have other utilities, potentially predicting postoperative delirium, episodes of intracranial hypertension, and even supratentorial herniation.

On the other hand, smooth pursuit involves conjugate eye movements that are required to maintain an object in motion on the fovea. The mechanism is quite complex, involving the lateral geniculate nucleus, primary visual cortex, middle temporal visual cortex, frontal pursuit area, superior colliculus, several pontine nuclei, the cerebellum, and nuclei of cranial nerves III, IV, and VI. It should not be surprising that cortical atrophy that occurs with normal aging or a dementing process may alter eye movements. The utility and relationship of pupillometry and Neurotrack™, alone and in combination with intraoperative electroencephalogram (EEG), is of immense interest. Prediction of post-operative delirium and cognitive decline with simple non-invasive means would be a significant clinical advancement.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
325

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Prevalence of delirium
Time Frame: Up to 2 years
Prevalence of delirium in in the post anesthesia care unit (PACU) will be calculated.
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Columbia University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Paul S. Garcia, MD, PhD, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 20, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 20, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 13, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 24, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AAAT9610
  • IRB00103151 (Other Identifier: Emory)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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