Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05579093 |
| Other study ID # |
AAAT9610 |
| Secondary ID |
IRB00103151 |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2019 |
| Est. completion date |
September 20, 2021 |
Study information
| Verified date |
May 2023 |
| Source |
Columbia University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
