Correlation of Preoperative Global Olfactory Function With Frailty, Perioperative Neurocognitive Disorders and Mortality

Correlation of Preoperative Global Olfactory Function With Frailty, Preoperative Cognitive Status, Postoperative Neurocognitive Disorders and Mortality Following Elective Surgery

Sponsors

Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Source Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Brief Summary

The aims of this research project are to evaluate whether global olfactory impairment is a reliable indicator of preoperative frailty and cognitive impairment, and whether it may predict postoperative neurocognitive disorders, morbidity and mortality in a population of older patients scheduled for elective intermediate- to high-risk elective surgery. 1. We will measure preoperative global olfactory function (threshold, discrimination, identification) and evaluate whether olfactory impairment predicts preoperative frailty (using the Edmonton Frail Scale, the Clinical Frailty Scale and handgrip strength) and postoperative complications and mortality. 2. We will address the question whether preoperative olfactory impairment may be associated with a preoperative cognitive impairment (through a neuropsychological test battery) and whether it may predict a decrease in postoperative neurocognitive function.

Detailed Description

Olfactory impairment increases with age, affecting more than 50% of the population aged between 65 and 80 years old. Recently, many studies have demonstrated a strong association between olfactory impairment and overall mortality risk. At the moment, the underlying physiopathology linking olfactory impairment to mortality remains unknown and only putative mechanisms are suggested. Among them, accelerated physiological brain aging seems to be involved, making olfactory decline a possible marker of frailty. To date, only a few studies (mostly using subjective olfactory assessment) investigated the potential relationship between olfactory impairment and frailty. Moreover, neurodegenerative diseases, through cognitive dysfunction, seem likely to represent a second mechanism potentially underlying the link between olfactory impairment and mortality. Surgery, and more broadly the perioperative period, remains a major source of morbidity and mortality. Meanwhile, the average age of the surgical population continues to rise, making preoperative risk assessment an essential step in order to detect the most vulnerable patients. Yet, it is well-known that frailty is predictive of complications and mortality and that preoperative cognitive impairment is associated with postoperative neurocognitive disorders. The first objective of this research project is thus to evaluate global olfactory function of preoperative older surgical patients in light of an assessment of their frailty and cognitive status. Frailty will be tested with the Edmonton Frail Scale, the Clinical Frailty Scale and handgrip strength. Cognitive function will be tested through a neuropsychological test battery preoperatively and postoperatively. The second and third objectives are to correlate preoperative olfactory function with, on the one hand, postoperative neurocognitive disorders, and on the other hand, postoperative morbidity and mortality.

Overall Status Not yet recruiting
Start Date March 2021
Completion Date March 2024
Primary Completion Date March 2024
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Prevalence of frailty assessed by the Edmonton Frail Scale Preoperative period (within 3 months before surgery)
Prevalence of frailty assessed by the Clinical Frailty Scale Preoperative period (within 3 months before surgery)
Incidence of postoperative complications Up to 1 year postoperatively
Incidence of mortality Up to 1 year postoperatively
Secondary Outcome
Measure Time Frame
Prevalence of preoperative neurocognitive disorder Preoperative period (within 3 months before surgery)
Incidence of postoperative neurocognitive disorder From 6 weeks to 12 weeks postoperatively
Enrollment 150
Condition
Intervention

Intervention Type: Diagnostic Test

Intervention Name: Olfactory function testing

Description: Olfactory function will be evaluated through the Burghart Sniffin' Sticks test which is a validated psychophysical testing method. Sniffin' Sticks test is based on pen-like odor dispensing devices that will be presented to the patients. The extended version of this test will be used and consist of three tests of olfactory function, namely tests for odor threshold, odor discrimination and odor identification.

Arm Group Label: Patients scheduled for elective surgery aged 65 and +

Intervention Type: Diagnostic Test

Intervention Name: Edmonton Frail Scale

Description: The Edmonton Frail Scale (EFS) involves nine domains of frailty : functional performance, cognitive function, general health, functional independence, social support, used medications, nutrition, mood and continence. It has been validated with respect to comprehensive geriatric assessment and to other screening tools related to frail state. EFS test is considered most appropriate for use in routine preoperative screening and only requires 5 minutes.

Arm Group Label: Patients scheduled for elective surgery aged 65 and +

Intervention Type: Diagnostic Test

Intervention Name: Clinical Frailty Scale

Description: The Clinical Frailty Scale (CFS) uses clinicians' judgement to evaluate frailty. It comprises assessment of specific domains including comorbidity, function, and cognition. Score ranges from 1 (very fit) to 9 (terminally ill).

Arm Group Label: Patients scheduled for elective surgery aged 65 and +

Intervention Type: Diagnostic Test

Intervention Name: Neuropsychological test battery

Description: Patients will undergo a neuropsychological test battery preoperatively and postoperatively. This test consists of a battery of psychometric assessments with the ability to objectively assess specific cognitive domains such as attention, executive function, learning and memory, language, perceptual-motor, or social cognition.

Arm Group Label: Patients scheduled for elective surgery aged 65 and +

Eligibility

Criteria:

Inclusion Criteria: - Scheduled for elective surgery (covering orthopedic, spine and cardiovascular surgery) Exclusion Criteria: - History of neurological or psychiatric disorder - History of severe head trauma - History of olfactory trouble or chronic rhinosinusitis or sinus surgery

Gender: All

Minimum Age: 65 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Last Name: Victoria Van Regemorter, MD

Phone: +3227641821

Email: [email protected]

Location
Facility: Contact: Contact Backup: Investigator: Cliniques universitaires Saint-Luc Victoria Van Regemorter, MD +3227641821 [email protected] Victoria Van Regemorter, MD Principal Investigator
Location Countries

Belgium

Verification Date

February 2021

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Patients scheduled for elective surgery aged 65 and +

Type: Experimental

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Screening

Masking: None (Open Label)

Source: ClinicalTrials.gov