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

2026年11月7日 更新者: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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

観察的

入学 (推定)

200

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

  • 名前:Kamuran K KOÇYİĞİT ÖZER, MD
  • 電話番号:5322082920
  • メール:kkcygt@gmail.com

研究場所

    • Ankara
      • Ankara、Ankara、トルコ(Türkiye)、06200
        • 募集
        • Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital, Department of Anesthesiology and Reanimation
        • コンタクト:
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

65年~70年 (高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 観測モデル:COHORT
  • 時間の展望:PROSPECTIVE

コホートと介入

グループ/コホート
介入・治療
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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Postoperative Intensive Care Unit (ICU) Admission Rate
時間枠: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.

二次結果の測定

結果測定
メジャーの説明
時間枠
30-Day Mortality Rate
時間枠: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).

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Özge K Cihangir Özek, MD、Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年7月1日

一次修了 (推定)

2027年5月5日

研究の完了 (推定)

2027年8月5日

試験登録日

最初に提出

2026年11月7日

QC基準を満たした最初の提出物

2026年11月7日

最初の投稿 (実際)

2026年11月13日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月13日

QC基準を満たした最後の更新が送信されました

2026年11月7日

最終確認日

2026年11月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 2026-06/130

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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.

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いいえ

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いいえ

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