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

NCT04761458 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 215

Last updated 2025-01-15

No results posted yet for this study

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.

Conditions

  • Frailty
  • Perioperative/Postoperative Complications
  • Olfactory Disorder
  • Neurocognitive Disorders
  • Postoperative Cognitive Dysfunction

Interventions

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

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

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.

Sponsors & Collaborators

  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    lead OTHER

Principal Investigators

  • Victoria Van Regemorter, MD · Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2023-12-22
Completion
2023-12-22

Countries

  • Belgium

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04761458 on ClinicalTrials.gov