- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Özge K Cihangir Özek, MD
- Numero di telefono: 05064969856
- Email: ozgecigangirozek@hotmail.com
Backup dei contatti dello studio
- Nome: Kamuran K KOÇYİĞİT ÖZER, MD
- Numero di telefono: 5322082920
- Email: kkcygt@gmail.com
Luoghi di studio
-
-
Ankara
-
Ankara, Ankara, Turchia (Türkiye), 06200
- Reclutamento
- Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital, Department of Anesthesiology and Reanimation
-
Contatto:
- Özge Cihangir Özek, MD
- Numero di telefono: 05064969856
- Email: ozgecihangirozek@hotmail.com
-
Contatto:
- Kamuran K Özer, MD
- Numero di telefono: 05322082920
- Email: kkcygt@gmail.com
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
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.
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: COHORT
- Prospettive temporali: PROSPECTIVE
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Postoperative Intensive Care Unit (ICU) Admission Rate
Lasso di tempo: 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.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
30-Day Mortality Rate
Lasso di tempo: 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).
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Özge K Cihangir Özek, MD, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2026-06/130
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano 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.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .