Clinical trial NCT05579093: Clinical Investigation of an Eye-Tracking Device as a Predictor of Delirium in the Recovery Room After Surgery With General Anesthesia
Official title: Clinical Investigation of an Eye-Tracking Device as a Predictor of Delirium in the Recovery Room After Surgery With General Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Keywords: Neurotrack™
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 325
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of delirium
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
Study officials:
affiliation: Columbia University
name: Paul S. Garcia, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: