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Geriatric Hip Fracture mFI-5 for Postoperative ICU Need and 30 Day Mortality

7. listopadu 2026 aktualizováno: özge cihangir özek, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Predictive Value of Modified Frailty Index-5 for Postoperative Intensive Care Unit Requirement and 30-Day Mortality in Geriatric Hip Fracture Patients

This prospective, observational, single-center study aims to evaluate the predictive value of the Modified Frailty Index-5 (mFI-5) score on postoperative intensive care unit (ICU) admission requirements and 30-day mortality in geriatric patients undergoing hip fracture surgery. Patients aged 65 and older presenting with a hip fracture will be evaluated preoperatively using the mFI-5 scoring system (assessing diabetes, hypertension, COPD, congestive heart failure, and functional dependence). Intraoperative hemodynamic data, anesthesia type, and transfusion requirements will be documented. Postoperative ICU admission, total hospital stay, and 30-day survival status will be recorded to assess the prognostic capability of preoperative frailty levels.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

This single-center, prospective, observational study will be conducted at the Department of Anesthesiology and Reanimation of Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital, following approval from the Institutional Ethics Committee. The primary objective is to evaluate the predictive value of the preoperative Modified Frailty Index-5 (mFI-5) score on postoperative intensive care unit (ICU) admission requirements and 30-day mortality in geriatric patients undergoing hip fracture surgery.

STUDY TIMELINE AND POPULATION Patient enrollment will take place between June 1, 2026, and January 1, 2027. All patients aged 65 years and older who present to the operating theater with a diagnosis of hip fracture (including femoral neck, intertrochanteric, or subtrochanteric fractures) and are scheduled for surgical treatment will be screened. Written informed consent will be obtained from all eligible patients or their legally authorized representatives in the preoperative period before any study-related procedures are initiated.

PREOPERATIVE ASSESSMENT (FRAILTY EVALUATION)

Prior to being transferred to the operating room, patients will be evaluated in the anesthesia outpatient clinic or the preoperative preparation holding area by a designated investigator. Frailty status will be determined using the Modified Frailty Index-5 (mFI-5), which consists of five distinct clinical criteria based on the patient's medical history:

  1. Presence of diabetes mellitus (regardless of insulin dependence).
  2. Presence of hypertension (requiring pharmacological treatment).
  3. History of Chronic Obstructive Pulmonary Disease (COPD).
  4. History of Congestive Heart Failure (CHF).
  5. Functional dependence status (defined as the need for assistance in performing activities of daily living within the last 30 days).

Each positive criterion will be scored as 1 point, yielding a total cumulative mFI-5 score ranging from 0 (robust/non-frail) to 5 (severely frail).

INTRAOPERATIVE MANAGEMENT AND MONITORING Upon arrival in the operating theater, standard American Society of Anesthesiologists (ASA) monitoring will be established for all patients, including electrocardiography (ECG), peripheral oxygen saturation (SpO2), and non-invasive blood pressure (NIBP). The choice of anesthesia method (general or regional anesthesia) will be decided by the primary attending anesthesia team based on patient comorbidities and clinical indications, and the type of anesthesia will be recorded.

Hemodynamic parameters, specifically systolic blood pressure, diastolic blood pressure, and heart rate, will be documented at 5-minute intervals throughout the operation. Intraoperative hypotension is strictly defined as a decrease of 20% or more from the patient's baseline blood pressure value. Episodes of hypotension will be managed according to standard clinical protocols using intravenous fluid resuscitation and/or vasopressors (e.g., ephedrine). Total intraoperative blood loss and the volume of blood products transfused will also be carefully quantified and recorded.

POSTOPERATIVE FOLLOW-UP AND OUTCOME MEASURES At the conclusion of the surgical procedure, the patient's requirement for intensive care unit (ICU) admission will be evaluated. Postoperative ICU admission will be determined based on standardized institutional clinical protocols, including the presence of hemodynamic instability, the need for mechanical ventilatory support, or the requirement for close invasive monitoring.

Following surgery, patients will be monitored through hospital discharge to determine the total length of hospital stay (measured in days). The primary definitive endpoints-survival status and the 30-day mortality rate-will be evaluated precisely 30 days after the operation. This long-term follow-up data will be retrieved directly from the national electronic hospital information system registries or via structured telephone interviews conducted with the patients or their primary caregivers. All collected variables will be documented in a dedicated case report form for final statistical modeling.

Typ studie

Pozorovací

Zápis (Odhadovaný)

200

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

  • Jméno: Kamuran K KOÇYİĞİT ÖZER, MD
  • Telefonní číslo: 5322082920
  • E-mail: kkcygt@gmail.com

Studijní místa

    • Ankara
      • Ankara, Ankara, Turecko (Türkiye), 06200
        • Nábor
        • Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital, Department of Anesthesiology and Reanimation
        • Kontakt:
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

65 let až 70 let (Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

The study population consists of geriatric patients aged 65 years and older who present to the emergency department or orthopedic clinics of a tertiary training and research hospital and are subsequently admitted to the operating theater for hip fracture surgery.

The cohort will encompass all consecutive eligible patients scheduled for surgical repair of a femoral neck, intertrochanteric, or subtrochanteric fracture under general or regional anesthesia between June 1, 2026, and January 1, 2027.

Popis

Inclusion Criteria:

Patients aged 65 years and older. Diagnosed with a hip fracture (including femoral neck, intertrochanteric, or subtrochanteric fractures).

Scheduled to undergo surgical treatment for the hip fracture. Anesthesia management planned under general or regional (spinal/epidural) anesthesia.

American Society of Anesthesiologists (ASA) physical status classification I, II, III, or IV.

Written informed consent provided voluntarily by the patient or their legally authorized representative prior to surgery.

Exclusion Criteria:

Patients under 65 years of age. Presence of high-energy injuries, major head trauma, or multiple trauma (polytrauma).

Patients who are intubated or require mechanical ventilation in the preoperative period.

Pathological fractures secondary to primary bone malignancies or bone metastases (if applicable per protocol).

Refusal to undergo surgery or failure/refusal to provide written informed consent.

Patients with missing 30-day postoperative follow-up data or incomplete medical records.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Observační modely: COHORT
  • Časové perspektivy: PROSPECTIVE

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
Geriatric Hip Fracture Patients

Geriatric patients aged 65 years and older who undergo surgical treatment for hip fracture (femoral neck, intertrochanteric, or subtrochanteric fractures) under general or regional anesthesia. All enrolled patients will be evaluated preoperatively using the Modified Frailty Index-5 (mFI-5) score and followed for 30 days postoperatively.

Preoperative frailty assessment using the Modified Frailty Index-5 (mFI-5) in the preoperative period. Standard perioperative care, including general or regional anesthesia tailored to the patient's clinical indications, intraoperative hemodynamic monitoring (every 5 minutes), and standard postoperative follow-up for ICU admission and 30-day mortality.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Postoperative Intensive Care Unit (ICU) Admission Rate
Časové okno: From the end of surgery up to 30 days postoperatively.

he percentage of patients requiring admission to the intensive care unit during the postoperative period based on standardized clinical protocols (e.g., hemodynamic instability, need for mechanical ventilatory support, or close invasive monitoring). The predictive accuracy and optimal cut-off value of the preoperative Modified Frailty Index-5 (mFI-5) score for this outcome will be determined using Receiver Operating Characteristic (ROC) curve analysis, calculating the Area Under the Curve (AUC), sensitivity, and specificity.

From the end of surgery up to 30 days postoperatively.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
30-Day Mortality Rate
Časové okno: From the day of hospital admission for surgery until official hospital discharge (approximately 30 days).

The total duration of hospitalization measured in days. The association between the preoperative mFI-5 frailty scores and the length of hospital stay will be analyzed to assess the impact of baseline frailty on resource utilization.

From the day of hospital admission for surgery until official hospital discharge (approximately 30 days).

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Vyšetřovatelé

  • Vrchní vyšetřovatel: Özge K Cihangir Özek, MD, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. července 2026

Primární dokončení (Odhadovaný)

5. května 2027

Dokončení studie (Odhadovaný)

5. srpna 2027

Termíny zápisu do studia

První předloženo

7. listopadu 2026

První předloženo, které splnilo kritéria kontroly kvality

7. listopadu 2026

První zveřejněno (Aktuální)

13. listopadu 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

13. listopadu 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

7. listopadu 2026

Naposledy ověřeno

1. listopadu 2026

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • 2026-06/130

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

Institutional review board restrictions and local data protection regulations (KVKK) prohibit the public sharing of individual participant data to ensure patient privacy. However, de-identified aggregate data and statistical analyses may be made available to qualified researchers upon reasonable collaborative request to the corresponding author.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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