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

NCT04761458 | Completed

• 1 other identifier: B403202043093
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 1

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. 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. 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

Outcome Measures

Primary Outcomes (4)

• Prevalence of frailty assessed by the Edmonton Frail Scale

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

  Preoperative period (within 3 months before surgery)

• Prevalence of frailty assessed by the Clinical Frailty Scale

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

  Preoperative period (within 3 months before surgery)

• Incidence of postoperative complications

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

  Up to 1 year postoperatively

• Incidence of mortality

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

  Up to 1 year postoperatively

Secondary Outcomes (2)

• Prevalence of preoperative neurocognitive disorder

  Preoperative period (within 3 months before surgery)

• Incidence of postoperative neurocognitive disorder

  From 6 weeks to 12 weeks postoperatively

Other Outcomes (1)

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

  From 6 weeks to 12 weeks postoperatively

Study Arms (1)

Patients scheduled for elective surgery aged 65 and +

EXPERIMENTAL

Diagnostic Test: Olfactory function testing; Diagnostic Test: Edmonton Frail Scale; Diagnostic Test: Clinical Frailty Scale; Diagnostic Test: Neuropsychological test battery

Interventions

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.

Patients scheduled for elective surgery aged 65 and +

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.

Patients scheduled for elective surgery aged 65 and +

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).

Patients scheduled for elective surgery aged 65 and +

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.

Patients scheduled for elective surgery aged 65 and +

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Scheduled for elective surgery (covering orthopedic, spine and cardiovascular surgery)

You may not qualify if:

• History of neurological or psychiatric disorder
• History of severe head trauma
• History of olfactory trouble or chronic rhinosinusitis or sinus surgery

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Related Publications (6)

• Pinto JM, Wroblewski KE, Kern DW, Schumm LP, McClintock MK. Olfactory dysfunction predicts 5-year mortality in older adults. PLoS One. 2014 Oct 1;9(10):e107541. doi: 10.1371/journal.pone.0107541. eCollection 2014.

  PMID: 25271633 BACKGROUND

• Schubert CR, Fischer ME, Pinto AA, Klein BEK, Klein R, Tweed TS, Cruickshanks KJ. Sensory Impairments and Risk of Mortality in Older Adults. J Gerontol A Biol Sci Med Sci. 2017 May 1;72(5):710-715. doi: 10.1093/gerona/glw036.

  PMID: 26946102 BACKGROUND

• Van Regemorter V, Hummel T, Rosenzweig F, Mouraux A, Rombaux P, Huart C. Mechanisms Linking Olfactory Impairment and Risk of Mortality. Front Neurosci. 2020 Feb 21;14:140. doi: 10.3389/fnins.2020.00140. eCollection 2020.

  PMID: 32153360 BACKGROUND

• Somekawa S, Mine T, Ono K, Hayashi N, Obuchi S, Yoshida H, Kawai H, Fujiwara Y, Hirano H, Kojima M, Ihara K, Kim H. Relationship between Sensory Perception and Frailty in a Community-Dwelling Elderly Population. J Nutr Health Aging. 2017;21(6):710-714. doi: 10.1007/s12603-016-0836-5.

  PMID: 28537337 BACKGROUND

• Laudisio A, Navarini L, Margiotta DPE, Fontana DO, Chiarella I, Spitaleri D, Bandinelli S, Gemma A, Ferrucci L, Incalzi RA. The Association of Olfactory Dysfunction, Frailty, and Mortality Is Mediated by Inflammation: Results from the InCHIANTI Study. J Immunol Res. 2019 Feb 20;2019:3128231. doi: 10.1155/2019/3128231. eCollection 2019.

  PMID: 30915369 BACKGROUND

• Harita M, Miwa T, Shiga H, Yamada K, Sugiyama E, Okabe Y, Miyake Y, Okuno T, Iritani O, Morimoto S. Association of olfactory impairment with indexes of sarcopenia and frailty in community-dwelling older adults. Geriatr Gerontol Int. 2019 May;19(5):384-391. doi: 10.1111/ggi.13621. Epub 2019 Apr 9.

  PMID: 30968523 BACKGROUND

MeSH Terms

Conditions

Frailty; Postoperative Complications; Neurocognitive Disorders; Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders; Cognitive Dysfunction; Cognition Disorders

Study Officials

• Victoria Van Regemorter, MD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 21, 2021
• Study Start: March 1, 2021
• Primary Completion: December 22, 2023
• Study Completion: December 22, 2023
• Last Updated: January 15, 2025

Record last verified: 2025-01

Locations

BE (1)