An interventional study of Olfactory function testing and Edmonton Frail Scale in Frailty, Perioperative/Postoperative Complications and Olfactory Disorder, sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. Completed at 1 site in Belgium. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-01-15.
Sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Not applicable, Interventional, and Screening
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.
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.
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This study's enrollment of 215 is above the median of 80 across 681 interventional studies indexed under Frailty.
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Diagnostic Test: Olfactory function testing · Diagnostic Test: Edmonton Frail Scale · Diagnostic Test: Clinical Frailty Scale · Diagnostic Test: Neuropsychological test battery
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.
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.
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).
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.
Prevalence of frailty assessed by the Edmonton Frail Scale
Analysis of the prevalence of frailty assessed by the Edmonton Frail Scale according to preoperative olfactory function (Burghart Sniffin' Sticks extended test).
Time frame: Preoperative period (within 3 months before surgery)
Prevalence of frailty assessed by the Clinical Frailty Scale
Analysis of the prevalence of frailty assessed by the Clinical Frailty Scale according to preoperative olfactory function (Burghart Sniffin' Sticks extended test).
Time frame: Preoperative period (within 3 months before surgery)
Incidence of postoperative complications
Analysis of the incidence of postoperative complications according to preoperative olfactory function (Burghart Sniffin' Sticks extended test).
Time frame: Up to 1 year postoperatively
Incidence of mortality
Analysis of the incidence of mortality according to preoperative olfactory function (Burghart Sniffin' Sticks extended test).
Time frame: Up to 1 year postoperatively
Prevalence of preoperative neurocognitive disorder
Analysis of the prevalence of neurocognitive disorder (assessed through a neuropsychological test battery) according to preoperative olfactory function.
Time frame: Preoperative period (within 3 months before surgery)
Incidence of postoperative neurocognitive disorder
Analysis of the incidence of postoperative neurocognitive disorder (assessed through a neuropsychological test battery) according to preoperative olfactory function.
Time frame: From 6 weeks to 12 weeks postoperatively
Postoperative global olfactory function (Burghart Sniffin' Sticks extended test)
Comparison of preoperative and postoperative global olfactory function (both assessed through Burghart Sniffin' Sticks extended test)
Time frame: From 6 weeks to 12 weeks postoperatively
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Cliniques universitaires Saint-Luc- Université Catholique de Louvain