- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT07936279
Geriatric Hip Fracture mFI-5 for Postoperative ICU Need and 30 Day Mortality
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.
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
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:
- Presence of diabetes mellitus (regardless of insulin dependence).
- Presence of hypertension (requiring pharmacological treatment).
- History of Chronic Obstructive Pulmonary Disease (COPD).
- History of Congestive Heart Failure (CHF).
- 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.
Tanulmány típusa
Beiratkozás (Becsült)
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Özge K Cihangir Özek, MD
- Telefonszám: 05064969856
- E-mail: ozgecigangirozek@hotmail.com
Tanulmányozza a kapcsolattartók biztonsági mentését
- Név: Kamuran K KOÇYİĞİT ÖZER, MD
- Telefonszám: 5322082920
- E-mail: kkcygt@gmail.com
Tanulmányi helyek
-
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Ankara
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Ankara, Ankara, Törökország (Türkiye), 06200
- Toborzás
- Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital, Department of Anesthesiology and Reanimation
-
Kapcsolatba lépni:
- Özge Cihangir Özek, MD
- Telefonszám: 05064969856
- E-mail: ozgecihangirozek@hotmail.com
-
Kapcsolatba lépni:
- Kamuran K Özer, MD
- Telefonszám: 05322082920
- E-mail: kkcygt@gmail.com
-
-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Mintavételi módszer
Tanulmányi populáció
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.
Leírás
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.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Megfigyelési modellek: COHORT
- Időperspektívák: PROSPECTIVE
Kohorszok és beavatkozások
Csoport / Kohorsz |
Beavatkozás / kezelés |
|---|---|
|
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. |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Postoperative Intensive Care Unit (ICU) Admission Rate
Időkeret: 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.
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
30-Day Mortality Rate
Időkeret: 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).
|
Együttműködők és nyomozók
Nyomozók
- Kutatásvezető: Özge K Cihangir Özek, MD, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Publikációk és hasznos linkek
Általános kiadványok
- Chan SF, Connelly M, Wallace DP. The Relationship Between Pain Characteristics, Peer Difficulties, and Emotional Functioning Among Adolescents Seeking Treatment for Chronic Pain: A Test of Mediational Models. J Pediatr Psychol. 2017 Oct 1;42(9):941-951. doi: 10.1093/jpepsy/jsx074.
- Tkachenko E, Singer S, Mostaghimi A, Hartman RI. Association of poor mental health and skin cancer development: a cross-sectional study of adults in the United States. Eur J Cancer Prev. 2020 Nov;29(6):520-522. doi: 10.1097/CEJ.0000000000000567.
- Hofmann B, Gerull KA, Bloch K, Riemer M, Erbs C, Frohlich A, Richter S, Ehrhardt M, Zitterbart C, Bartel FF, Siegel P, Wienke A, Silber RE, Simm A. It's all in our skin-Skin autofluorescence-A promising outcome predictor in cardiac surgery: A single centre cohort study. PLoS One. 2020 Jun 29;15(6):e0234847. doi: 10.1371/journal.pone.0234847. eCollection 2020.
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 2026-06/130
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
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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