Correlation of Preoperative Olfactory Identification Function With Frailty and Postoperative Complications and Mortality (POOF)
Primary Purpose
Frailty, Perioperative/Postoperative Complications, Olfactory Disorder
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Olfactory identification test
Edmonton Frail Scale
Handgrip strength
Sponsored by
About this trial
This is an interventional screening trial for Frailty
Eligibility Criteria
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
Sites / Locations
- Cliniques universitaires Saint-Luc
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
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
Analysis of the incidence of postoperative complications and mortality according to preoperative olfactory identification function
Secondary Outcome Measures
Full Information
NCT ID
NCT04700891
First Posted
December 18, 2020
Last Updated
February 23, 2022
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1. Study Identification
Unique Protocol Identification Number
NCT04700891
Brief Title
Correlation of Preoperative Olfactory Identification Function With Frailty and Postoperative Complications and Mortality
Acronym
POOF
Official Title
Correlation of Preoperative Olfactory Identification Function With Preoperative Frailty and With Postoperative Complications and Mortality Following Elective Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
July 27, 2020 (Actual)
Primary Completion Date
February 1, 2021 (Actual)
Study Completion Date
February 1, 2022 (Actual)
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 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.
The investigators will measure preoperative olfactory identification function and evaluate whether olfactory impairment predicts frailty, using the Edmonton Frail Scale and handgrip strength.
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.
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
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
167 (Actual)
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 identification test
Intervention Description
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.
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)
Handgrip strength
Intervention Description
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.
Primary Outcome Measure Information:
Title
Prevalence of frailty
Description
Analysis of the prevalence of frailty (assessed by the Edmonton Frail Scale and handgrip strength) according to preoperative olfactory identification function
Time Frame
The day before surgery (preoperative period)
Title
Incidence of postoperative complications and mortality
Description
Analysis of the incidence of postoperative complications and mortality according to preoperative olfactory identification function
Time Frame
Up to 1 year postoperatively
Other Pre-specified Outcome Measures:
Title
Postoperative olfactory identification function
Description
Comparison of preoperative and postoperative olfactory identification function (assessed by the Sniffin' Sticks "Screening 12 test")
Time Frame
During first postoperative day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victoria Van Regemorter, MD
Organizational Affiliation
Cliniques universitaires Saint-Luc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cliniques universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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 Olfactory Identification Function With Frailty and Postoperative Complications and Mortality
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