Can a New EEG Based Tool Predict Post-operative Delirium and Cognitive Dysfunction?

NCT03293550 | Completed

• 1 other identifier: 185-17 rambam-CTIL
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

As the population ages and medical progress is made, many elderly patients that previously would not have been candidates for surgery are now undergoing operations. In this group of older patients, brain dysfunction after anesthesia and surgery is well recognized and categorized into two distinct clinical entities; Post-operative cognitive delirium (POD) and post-operative cognitive dysfunction (POCD). Delirium is an acute and fluctuating deterioration in attention accompanied by either a change in cognition or arousal and is often diagnosed by criteria established in the Confusion Assessment Method (CAM). Delirium can present as hypoactive (decreased alertness, motor activity and anhedonia), as hyperactive (agitated and combative) or as mixed forms. Age and the type of operation are the major risk factors. Post-operative cognitive dysfunction (POCD) is a term used to describe subtle changes in cognition, such as memory and executive function. The most commonly seen problems are memory impairment and impaired performance on intellectual tasks. In severe cases, it can lead to inability to perform daily living functions. It was previously found that the presence of cognitive dysfunction 3 months after non-cardiac surgery was associated with an increased mortality. The mechanisms leading to cognitive impairment after anesthesia and surgery are not yet fully clear. The risk factors are related to patient characteristics, type of operation and anesthetic management. Despite its limitations over-anesthesia as monitored by BIS was at-least correlative with POD. Therefore it is hopeful that an even more precise evaluation of the level of anesthesia will improve POD prediction (and thereby prevention) even further. On the other hand the measure of depth of anesthesia by itself does not provide sufficient prediction for POCD. In POCD a major role has been assigned to hippocampal damage. The investigators have recently demonstrated that temporary hippocampal interruptions are manifested by interhemispheric desynchronization, which are recognized by our new algorithm, which monitors electrophysiological markers of attention and of perception. The investigators have developed a unique algorithm for analyzing EEG based on the concept of monitoring perception and attention and their interhemispheric synchronization. The aims of this proof of concept study are: (i) to find-out whether interhemispheric desynchronization of attentional processes is associated with POCD; (ii) to find out whether the level of anesthesia, is linked primary to POD and secondary to POCD.

Conditions

Delirium; Cognitive Dysfunction

Outcome Measures

Primary Outcomes (4)

• Correlation of depth of anesthesia to post operative delirium

  Correlation of depth of anesthesia, as measured by a new EEG based algorithm, to post operative delirium

  The diagnosis of delirium is assessed two hours after the operation, when the patient is fully awake, in the post anesthesia care unit (PACU)

• Correlation of intra operative EEG changes to early post operative cognitive dysfunction

  Correlation of EEG changes as measured by a new EEG based algorithm to post operative cognitive dysfunction

  The diagnosis of cognitive dysfunction is assessed post operative on day 7 and compared to baseline pre surgery cognitive function.

• Correlation of intra operative EEG changes to 45 days post operative cognitive dysfunction

  Correlation of EEG changes as measured by a new EEG based algorithm to post operative cognitive dysfunction

  The diagnosis of cognitive dysfunction is assessed post operative on day 45 and is compared to baseline pre surgery cognitive function.

• Correlation of intra operative EEG changes to late post operative cognitive dysfunction

  Correlation of EEG changes as measured by a new EEG based algorithm to post operative cognitive dysfunction

  The diagnosis of cognitive dysfunction is assessed post operative on day 90 and is compared to baseline pre surgery cognitive function.

Study Arms (1)

patients over 65 years undergoing elective surgery

patients over 65 years undergoing elective cardiac surgery or elective hip or knee surgery

Eligibility Criteria

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

Study Population

Patients 65 years or older, ASA 1-4, undergoing elective cardiac surgery (CABG or valve replacement) or hip/knee replacement.

You may qualify if:

• Patients 65 years or older undergoing elective cardiac surgery (CABG or valve replacement) or hip/knee replacement.

You may not qualify if:

• inability or refusal to provide informed consent,
• significant visual impairment so that the pictures of the confusion assessment method could not be interpreted to accurately test to assess delirium,
• profound dementia or aphasia that interfered with the assessment of delirium,
• inability to speak Hebrew/ Russian or Arabic so that a language barrier was not confused with postoperative confusion.
• Any previously documented major neurologic or psychiatric dysfunction

Sponsors & Collaborators

• Rambam Health Care Campus: lead
• Neuroindex Ltd.: collaborator

Study Sites (1)

Rambam Health Care Campus

Haifa, Israel

Location

Related Publications (15)

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MeSH Terms

Conditions

Delirium; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: August 31, 2017
• First Posted: September 26, 2017
• Study Start: December 31, 2017
• Primary Completion: September 6, 2020
• Study Completion: September 6, 2020
• Last Updated: September 17, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)