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Correlation of Preoperative Olfactory Identification Function With Frailty and Postoperative Complications and Mortality

Correlation of Preoperative Olfactory Identification Function With Preoperative Frailty and With Postoperative Complications and Mortality Following Elective Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04700891
Acronym
POOF
Enrollment
167
Registered
2021-01-08
Start date
2020-07-27
Completion date
2022-02-01
Last updated
2022-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frailty, Perioperative/Postoperative Complications, Olfactory Disorder

Brief summary

The aim of this research project is to evaluate whether olfactory identification impairment is a reliable predictor of preoperative frailty and of postoperative complications and mortality in a population of older patients scheduled for elective surgery. 1. The investigators will measure preoperative olfactory identification function and evaluate whether olfactory impairment predicts frailty, using the Edmonton Frail Scale and handgrip strength. 2. The investigators will analyze whether preoperative olfactory impairment predicts postoperative complications and mortality.

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. 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 associated with worse perioperative outcome. The first objective of this research project is thus to evaluate olfactory identification function of preoperative older surgical patients in light of an assessment of their frailty status. Frailty will be tested with the Edmonton Frail Scale and handgrip strength, which are both validated tools. The second objective is to correlate postoperative morbidity and mortality with preoperative olfactory function. Hopefully, this research project will address the misunderstood link between olfactory impairment and mortality, focusing on frailty assessment and using surgery as a heavy stressor for the older patient.

Interventions

DIAGNOSTIC_TESTOlfactory identification test

Burghart Sniffin' Sticks Screening 12 Test Olfactory function will be evaluated through the 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 short version of this test will be used and will consist solely of a test of odor identification function.

DIAGNOSTIC_TESTEdmonton 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_TESTHandgrip strength

Handgrip strength is a simple and reliable measurement technique for the assessment of maximal voluntary hand force. Handgrip strength is used as a reflect of nutritional status and muscle mass, physical function and health status. Measurement will be realized using a digital handgrip dynamometer. Patients will be asked to grip the dynamometer with the second finger node at 90° angle to the handle and to grab the handle as strongly as they can. Maximal grip strength will be checked with the forearm away from the body in standing position.

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Scheduled for elective surgery (covering general, gynecologic, urologic, orthopedic, plastic, head and neck, spine neurosurgery)

Exclusion criteria

* Day case surgery * History of neurological or psychiatric disorder * History of severe head trauma * History of olfactory trouble or chronic rhinosinusitis or sinus surgery * History of suspected or diagnosed COVID-19

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of frailtyThe day before surgery (preoperative period)Analysis of the prevalence of frailty (assessed by the Edmonton Frail Scale and handgrip strength) according to preoperative olfactory identification function
Incidence of postoperative complications and mortalityUp to 1 year postoperativelyAnalysis of the incidence of postoperative complications and mortality according to preoperative olfactory identification function

Other

MeasureTime frameDescription
Postoperative olfactory identification functionDuring first postoperative dayComparison of preoperative and postoperative olfactory identification function (assessed by the Sniffin' Sticks Screening 12 test)

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026