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Completed

NCT Number: NCT04761458

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

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.

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Key information

Conditions

Frailty Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders Olfactory Disorder Pathologic Processes Pathological Conditions, Signs and Symptoms Perioperative/Postoperative Complications Postoperative Cognitive Complications Postoperative Cognitive Dysfunction Postoperative Complications

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olfactory function testing

Diagnostic Test

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.

Edmonton Frail Scale

Diagnostic Test

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.

Clinical Frailty Scale

Diagnostic Test

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).

Neuropsychological test battery

Diagnostic Test

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.

Primary outcomes

  1. Prevalence of frailty assessed by the Edmonton Frail Scale

    Time frame: Preoperative period (within 3 months before surgery)

    Analysis of the prevalence of frailty assessed by the Edmonton Frail Scale according to preoperative olfactory function (Burghart Sniffin' Sticks extended test).

  2. Prevalence of frailty assessed by the Clinical Frailty Scale

    Time frame: Preoperative period (within 3 months before surgery)

    Analysis of the prevalence of frailty assessed by the Clinical Frailty Scale according to preoperative olfactory function (Burghart Sniffin' Sticks extended test).

  3. Incidence of postoperative complications

    Time frame: Up to 1 year postoperatively

    Analysis of the incidence of postoperative complications according to preoperative olfactory function (Burghart Sniffin' Sticks extended test).

  4. Incidence of mortality

    Time frame: Up to 1 year postoperatively

    Analysis of the incidence of mortality according to preoperative olfactory function (Burghart Sniffin' Sticks extended test).

Secondary outcomes

  1. Prevalence of preoperative neurocognitive disorder

    Time frame: Preoperative period (within 3 months before surgery)

    Analysis of the prevalence of neurocognitive disorder (assessed through a neuropsychological test battery) according to preoperative olfactory function.

  2. Incidence of postoperative neurocognitive disorder

    Time frame: From 6 weeks to 12 weeks postoperatively

    Analysis of the incidence of postoperative neurocognitive disorder (assessed through a neuropsychological test battery) according to preoperative olfactory function.

Other outcomes

  1. Postoperative global olfactory function (Burghart Sniffin' Sticks extended test)

    Time frame: From 6 weeks to 12 weeks postoperatively

    Comparison of preoperative and postoperative global olfactory function (both assessed through Burghart Sniffin' Sticks extended test)

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 21, 2021
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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