Recrutement en cours

Feasibility and Validity of Frailty Screening Tools as a Measure of Postoperative Outcomes in Older Patients Undergoing Elective Surgery

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Ce qui est collecté

Collecte de données

Données recueillies dès le début de l'étude - Prospective
Qui peut participer

Fragilité

+ Processus pathologiques

+ Conditions pathologiques, signes et symptômes

À partir de 70 ans
+3 critères d'éligibilité
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Cohorte

Suivi d'un groupe de personnes dans le temps pour mieux comprendre les causes et l'évolution d'une maladie.
Observationnel
Date de début : janvier 2025
Voir le détail du protocole

Résumé

Sponsor principalUniversity of Iceland
Contacts de l'étudeMartin I Sigurdsson, MD, PhDVoir plus de contacts
Dernière mise à jour : 27 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer cette étude

Date de début de l'étude : 20 janvier 2025

Date à laquelle le premier participant a commencé l'étude.

Frailty is a common geriatric syndrome defined as a clinical state of decreased physiologic reserve resulting in increased vulnerability to stressors. It is associated with several unfavorable postoperative complications independent of age such as readmission, length of hospital stay and mortality. To address these concerns, medical societies have acknowledged a need for routine screening to identify elderly patients who are at high risk for major complications before undergoing surgery. In the absence of a golden standard for frailty assessment, there are multiple assessment tools available. However, the challenge with many frailty tools is that they can be time-consuming, and require expertise and clinical training.This poses a challenge for screening a large elderly population before surgery. Some frailty assessment tools, such as PRISMA7 (The Program of Research to Integrate Services for the Maintenance of Autonomy), timed up and go (TUG) and the clock drawing test (CDT), have been demonstrated to be quick, simple and easy to use with minimal training. The PRISMA-7 is a frailty screening questionnaire that consists of seven dichotomous items considering age, gender, health problems that affect activities of daily living (ADLs), assistance from others with ADLs, having to count on someone if needed, and the use of mobility aids. The TUG test is used for assessing fall risk and frailty in older patients. It is measured by the time it takes an individual to stand up from a seated position, walk three meters and return back to a seated position. There is no standard cut-off for TUG, however, a cut-off of > 10 seconds has been used to identify frailty. Cognitive impairment in older surgical patients may predispose patients to executive dysfunction that many elderly patients experience postoperatively and has shown to be a risk factor for surgical complications. Some studies suggest a strong relationship between cognitive impairment and physical frailty resulting in cognitive frailty when evaluating older adults.The CDT has shown to be a valuable screening tool for cognitive concerns. When administering the CDT, a patient receives instructions to draw a clock. Performing the test requires auditory comprehension, planning, sustained attention, visual-spatial skills and executive skills. The prevalence of surgical frailty in Iceland has not been researched thoroughly enough to provide an accurate estimate. This is important to reveal the number of senior surgical patients at high risk of adverse postoperative outcomes who could benefit from a preoperative intervention. However, there is a lack of consensus on an optimal frailty assessment to screen patients for identifying frail patients prior to surgery, and more research is needed to evaluate which group of patients would benefit the most from prehabilitation. The scientific value of this study is to elucidate the extent of frailty risk and its associated postoperative outcomes in older surgical patients undergoing elective surgery. We opt to find a convenient screening routine prior to surgery to identify patients at risk of frailty. Therefore, the study aims to validate three frailty screening methods and to assess a positive screening result as an independent risk factor for adverse postoperative outcomes in a cohort of elderly surgical patients undergoing elective surgery. We hypothesize that elderly patients at risk of frailty have a higher rate of surgical complications than patients not at risk of frailty. Patients aged ≥ 70 years who undergo elective surgery will be prospectively examined at the Department of Anesthesiology and Critical Care of Landspítali. The screening assessments to be evaluated are the Program of Research to Integrate Services for the Maintenance of Autonomy (PRISMA-7), a combination of Timed Up \& Go (TUG), Clock Drawing Test (CDT) and the FRAIL questionnaire, and a combination of PRISMA-7, TUG and CDT. Additional clinical data and outcomes will be obtained from the electronic medical records of Landspítali. The postoperative outcomes measured will be 180-day mortality, surgical complications, 90-day readmission, delirium, non-home discharge and length of hospital stay. Patients who screen positive on the CDT (≤ 2/3 points) and TUG (≥ 11 seconds) will be considered frail. Those who do not screen positive on both of these tests will be part of the control group (non-frail).

Titre officielFeasibility and Validity of Frailty Screening Tools as a Measure of Postoperative Outcomes in Older Patients Undergoing Elective Surgery 
Sponsor principalUniversity of Iceland
Contacts de l'étudeMartin I Sigurdsson, MD, PhDVoir plus de contacts
Dernière mise à jour : 27 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer cette étude

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

350 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Cohorte

Ce type d'étude observe, sur une période définie, un groupe de personnes partageant une caractéristique commune (comme une maladie ou une année de naissance), afin d'analyser leur état de santé ou leur exposition à certains facteurs.

Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

À partir de 70 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

FragilitéProcessus pathologiquesConditions pathologiques, signes et symptômes

Critères

2 critères d'inclusion nécessaires pour participer
Patients ≥ 70 years who present for preoperative work-up at the anesthesia department at Landspitali.

Patients assigned to undergo intermediate/major surgery

Un critère d'exclusion empêche la participation
Not undergoing planned surgery

Plan de l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.
Objectifs de l'étude

Objectifs de l'étude

Objectifs secondaires

Centres d'étude

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Cette étude comporte 1 site

Recrutement en cours

Landspitali - The national university hospital in Iceland.

Reykjavik, IcelandVoir le site
Recrutement en cours
1 Centres d'Étude