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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Neurocognitive Disorders; Postoperative Cognitive Dysfunction; Frailty; Perioperative/Postoperative Complications; Olfactory Disorder
• Intervention / Treatment: Diagnostic test: Edmonton Frail Scale; Diagnostic test: Olfactory function testing; Diagnostic test: Clinical Frailty Scale; Diagnostic test: Neuropsychological test battery

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Saint-Luc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 63 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients scheduled for elective surgery aged 65 and +

Diagnostic test: Edmonton Frail Scale; 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.; Diagnostic test: Olfactory function testing; 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.; Diagnostic test: Clinical Frailty Scale; 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).; Diagnostic test: Neuropsychological test battery; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	Up to 1 year postoperatively
Incidence of mortality	Analysis of the incidence of mortality according to preoperative olfactory function (Burghart Sniffin' Sticks extended test).	Up to 1 year postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of preoperative neurocognitive disorder	Analysis of the prevalence of neurocognitive disorder (assessed through a neuropsychological test battery) according to preoperative olfactory function.	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.	From 6 weeks to 12 weeks postoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	From 6 weeks to 12 weeks postoperatively

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Pinto JM, Wroblewski KE, Kern DW, Schumm LP, McClintock MK. Olfactory dysfunction predicts 5-year mortality in older adults. PLoS One. 2014 Oct 1;9(10):e107541. doi: 10.1371/journal.pone.0107541. eCollection 2014.
• Schubert CR, Fischer ME, Pinto AA, Klein BEK, Klein R, Tweed TS, Cruickshanks KJ. Sensory Impairments and Risk of Mortality in Older Adults. J Gerontol A Biol Sci Med Sci. 2017 May 1;72(5):710-715. doi: 10.1093/gerona/glw036.
• Somekawa S, Mine T, Ono K, Hayashi N, Obuchi S, Yoshida H, Kawai H, Fujiwara Y, Hirano H, Kojima M, Ihara K, Kim H. Relationship between Sensory Perception and Frailty in a Community-Dwelling Elderly Population. J Nutr Health Aging. 2017;21(6):710-714. doi: 10.1007/s12603-016-0836-5.
• Laudisio A, Navarini L, Margiotta DPE, Fontana DO, Chiarella I, Spitaleri D, Bandinelli S, Gemma A, Ferrucci L, Incalzi RA. The Association of Olfactory Dysfunction, Frailty, and Mortality Is Mediated by Inflammation: Results from the InCHIANTI Study. J Immunol Res. 2019 Feb 20;2019:3128231. doi: 10.1155/2019/3128231. eCollection 2019.
• Harita M, Miwa T, Shiga H, Yamada K, Sugiyama E, Okabe Y, Miyake Y, Okuno T, Iritani O, Morimoto S. Association of olfactory impairment with indexes of sarcopenia and frailty in community-dwelling older adults. Geriatr Gerontol Int. 2019 May;19(5):384-391. doi: 10.1111/ggi.13621. Epub 2019 Apr 9.
• Van Regemorter V, Hummel T, Rosenzweig F, Mouraux A, Rombaux P, Huart C. Mechanisms Linking Olfactory Impairment and Risk of Mortality. Front Neurosci. 2020 Feb 21;14:140. doi: 10.3389/fnins.2020.00140. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: February 3, 2021
• First Submitted That Met QC Criteria: February 17, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Estimated): December 7, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Cognition Disorders; Cognitive Dysfunction; Frailty; Postoperative Cognitive Complications; Postoperative Complications; Neurocognitive Disorders
• Other Study ID Numbers: B403202043093

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No