NCT04700891

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. 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. 2.The investigators will analyze whether preoperative olfactory impairment predicts postoperative complications and mortality.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
167

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 27, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 8, 2021

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

February 24, 2022

Status Verified

February 1, 2022

Enrollment Period

6 months

First QC Date

December 18, 2020

Last Update Submit

February 23, 2022

Conditions

FrailtyPerioperative/Postoperative ComplicationsOlfactory Disorder

Outcome Measures

Primary Outcomes (2)

  • Prevalence of frailty

    Analysis of the prevalence of frailty (assessed by the Edmonton Frail Scale and handgrip strength) according to preoperative olfactory identification function

    The day before surgery (preoperative period)

  • Incidence of postoperative complications and mortality

    Analysis of the incidence of postoperative complications and mortality according to preoperative olfactory identification function

    Up to 1 year postoperatively

Other Outcomes (1)

  • Postoperative olfactory identification function

    During first postoperative day

Study Arms (1)

Patients scheduled for elective surgery aged 65 and +

EXPERIMENTAL
Diagnostic Test: Olfactory identification testDiagnostic Test: Edmonton Frail ScaleDiagnostic Test: Handgrip strength

Interventions

Olfactory identification testDIAGNOSTIC_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.

Patients scheduled for elective surgery aged 65 and +
Edmonton Frail ScaleDIAGNOSTIC_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 +
Handgrip strengthDIAGNOSTIC_TEST

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.

Patients scheduled for elective surgery aged 65 and +

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Related Publications (7)

  • 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: 25271633BACKGROUND

  • 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: 26946102BACKGROUND

  • 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: 32153360BACKGROUND

  • 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: 28537337BACKGROUND

  • 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: 30915369BACKGROUND

  • 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: 30968523BACKGROUND

  • Van Regemorter V, Coulie R, Dollase J, Momeni M, Stouffs A, Quenon L, Mouraux A, Huart C. Poor preoperative performance at Clock Drawing Test is associated with postoperative decline in olfaction in older patients: an observational pilot study. BMC Anesthesiol. 2023 Aug 30;23(1):295. doi: 10.1186/s12871-023-02256-0.

    PMID: 37648990DERIVED

MeSH Terms

Conditions

FrailtyPostoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

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

December 18, 2020

First Posted

January 8, 2021

Study Start

July 27, 2020

Primary Completion

February 1, 2021

Study Completion

February 1, 2022

Last Updated

February 24, 2022

Record last verified: 2022-02

Locations

BE(1)