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

Not Applicable

Completed

• Conditions: Frailty; Olfactory Disorder; Perioperative/Postoperative Complications
• Interventions: Diagnostic Test: Olfactory identification test; Diagnostic Test: Edmonton Frail Scale; Diagnostic Test: Handgrip strength

• Registration Number: NCT04700891
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Study Timeline

• Study Start: 2020-07-27
• Study First Submitted: 2020-12-18
• Study First Submitted QC: 2021-01-07
• Study First Posted: 2021-01-08
• Primary Completion: 2021-02-01
• Status Verified: 2022-02
• Study Completion: 2022-02-01
• Last Update Submitted: 2022-02-23
• Last Update Posted: 2022-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 167

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients scheduled for elective surgery aged 65 and +	Edmonton Frail Scale	-
Patients scheduled for elective surgery aged 65 and +	Olfactory identification test	-
Patients scheduled for elective surgery aged 65 and +	Handgrip strength	-

Primary Outcome Measures

Name	Time	Method
Prevalence of frailty	The 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 mortality	Up to 1 year postoperatively	Analysis of the incidence of postoperative complications and mortality according to preoperative olfactory identification function

Trial Locations

Locations (1)

Cliniques universitaires Saint-Luc; 🇧🇪 Brussels, Belgium