Viewing Study NCT04761458



Ignite Creation Date: 2024-05-06 @ 3:48 PM
Last Modification Date: 2024-10-26 @ 1:57 PM
Study NCT ID: NCT04761458
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2023-12-07
First Post: 2021-02-03

Brief Title: Correlation of Preoperative Global Olfactory Function With Frailty Perioperative Neurocognitive Disorders and Mortality
Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Organization: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study Overview

Official Title: Correlation of Preoperative Global Olfactory Function With Frailty Preoperative Cognitive Status Postoperative Neurocognitive Disorders and Mortality Following Elective Surgery
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2023-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None