Correlation of Preoperative Global Olfactory Function With Frailty, Perioperative Neurocognitive Disorders and Mortality
Primary Purpose
Frailty, Perioperative/Postoperative Complications, Olfactory Disorder
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Olfactory function testing
Edmonton Frail Scale
Clinical Frailty Scale
Neuropsychological test battery
Sponsored by
About this trial
This is an interventional screening trial for Frailty
Eligibility Criteria
Inclusion Criteria:
- Scheduled for elective surgery (covering orthopedic, spine and cardiovascular surgery)
Exclusion Criteria:
- History of neurological or psychiatric disorder
- History of severe head trauma
- History of olfactory trouble or chronic rhinosinusitis or sinus surgery
Sites / Locations
- Cliniques universitaires Saint-LucRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients scheduled for elective surgery aged 65 and +
Arm Description
Outcomes
Primary Outcome Measures
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).
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).
Incidence of postoperative complications
Analysis of the incidence of postoperative complications according to preoperative olfactory function (Burghart Sniffin' Sticks extended test).
Incidence of mortality
Analysis of the incidence of mortality according to preoperative olfactory function (Burghart Sniffin' Sticks extended test).
Secondary Outcome Measures
Prevalence of preoperative neurocognitive disorder
Analysis of the prevalence of neurocognitive disorder (assessed through a neuropsychological test battery) according to preoperative olfactory function.
Incidence of postoperative neurocognitive disorder
Analysis of the incidence of postoperative neurocognitive disorder (assessed through a neuropsychological test battery) according to preoperative olfactory function.
Full Information
NCT ID
NCT04761458
First Posted
February 3, 2021
Last Updated
November 9, 2022
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1. Study Identification
Unique Protocol Identification Number
NCT04761458
Brief Title
Correlation of Preoperative Global Olfactory Function With Frailty, Perioperative Neurocognitive Disorders and Mortality
Official Title
Correlation of Preoperative Global Olfactory Function With Frailty, Preoperative Cognitive Status, Postoperative Neurocognitive Disorders and Mortality Following Elective Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty, Perioperative/Postoperative Complications, Olfactory Disorder, Neurocognitive Disorders, Postoperative Cognitive Dysfunction
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients scheduled for elective surgery aged 65 and +
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Olfactory function testing
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Edmonton Frail Scale
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Clinical Frailty Scale
Intervention Description
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).
Intervention Type
Diagnostic Test
Intervention Name(s)
Neuropsychological test battery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Prevalence of frailty assessed by the Edmonton Frail Scale
Description
Analysis of the prevalence of frailty assessed by the Edmonton Frail Scale according to preoperative olfactory function (Burghart Sniffin' Sticks extended test).
Time Frame
Preoperative period (within 3 months before surgery)
Title
Prevalence of frailty assessed by the Clinical Frailty Scale
Description
Analysis of the prevalence of frailty assessed by the Clinical Frailty Scale according to preoperative olfactory function (Burghart Sniffin' Sticks extended test).
Time Frame
Preoperative period (within 3 months before surgery)
Title
Incidence of postoperative complications
Description
Analysis of the incidence of postoperative complications according to preoperative olfactory function (Burghart Sniffin' Sticks extended test).
Time Frame
Up to 1 year postoperatively
Title
Incidence of mortality
Description
Analysis of the incidence of mortality according to preoperative olfactory function (Burghart Sniffin' Sticks extended test).
Time Frame
Up to 1 year postoperatively
Secondary Outcome Measure Information:
Title
Prevalence of preoperative neurocognitive disorder
Description
Analysis of the prevalence of neurocognitive disorder (assessed through a neuropsychological test battery) according to preoperative olfactory function.
Time Frame
Preoperative period (within 3 months before surgery)
Title
Incidence of postoperative neurocognitive disorder
Description
Analysis of the incidence of postoperative neurocognitive disorder (assessed through a neuropsychological test battery) according to preoperative olfactory function.
Time Frame
From 6 weeks to 12 weeks postoperatively
Other Pre-specified Outcome Measures:
Title
Postoperative global olfactory function (Burghart Sniffin' Sticks extended test)
Description
Comparison of preoperative and postoperative global olfactory function (both assessed through Burghart Sniffin' Sticks extended test)
Time Frame
From 6 weeks to 12 weeks postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Scheduled for elective surgery (covering orthopedic, spine and cardiovascular surgery)
Exclusion Criteria:
History of neurological or psychiatric disorder
History of severe head trauma
History of olfactory trouble or chronic rhinosinusitis or sinus surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Victoria Van Regemorter, MD
Phone
+3227641821
Email
victoria.vanregemorter@uclouvain.be
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline Huart, MD, PhD
Phone
+3227646005
Email
caroline.huart@uclouvain.be
Facility Information:
Facility Name
Cliniques universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria Van Regemorter, MD
Phone
+3227641821
Email
victoria.vanregemorter@uclouvain.be
First Name & Middle Initial & Last Name & Degree
Caroline Huart, MD, PhD
Phone
+3227646005
Email
caroline.huart@uclouvain.be
First Name & Middle Initial & Last Name & Degree
Victoria Van Regemorter, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
25271633
Citation
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.
Results Reference
background
PubMed Identifier
26946102
Citation
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.
Results Reference
background
PubMed Identifier
32153360
Citation
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.
Results Reference
background
PubMed Identifier
28537337
Citation
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.
Results Reference
background
PubMed Identifier
30915369
Citation
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.
Results Reference
background
PubMed Identifier
30968523
Citation
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.
Results Reference
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Correlation of Preoperative Global Olfactory Function With Frailty, Perioperative Neurocognitive Disorders and Mortality
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