Orthopedic Procedures and Postoperative Delirium in Older Adults in the Czech Republic

Официальное название

Orthopedic Procedures and Postoperative Delirium in the Czech Republic

Обзор

This multicenter, prospective, non-interventional observational study (ORTOPODCZ) investigates the association between preoperative cognitive impairment and postoperative delirium (POD) in older adults undergoing elective total hip arthroplasty in the Czech Republic. Postoperative delirium is a frequent and serious neurocognitive complication in senior surgical patients and is associated with increased morbidity, mortality, prolonged hospitalization, and impaired functional and cognitive outcomes. Despite international recommendations, routine preoperative cognitive screening remains insufficiently implemented. The study evaluates the predictive value of the ALBA test, a brief cognitive screening tool, performed during the pre-anesthetic assessment. Postoperative delirium will be assessed using the validated CAM-ICU instrument for up to 72 hours after surgery. Secondary objectives include assessing the relationship between POD and frailty, polypharmacy, comorbidities, type of anesthesia, intraoperative hemodynamics, blood loss, vasoactive support, and postoperative complications. Approximately 300-400 participants aged ≥65 years will be enrolled across seven centers. No additional procedures, biological sampling, or deviations from standard clinical care are required. Data will be collected in REDCap and analyzed according to a predefined statistical analysis plan. The study aims to provide robust evidence supporting the integration of cognitive screening into routine preoperative evaluation and to describe feasibility and implementation requirements for the ALBA test in clinical practice.

Подробное описание

Postoperative delirium (POD) is one of the most common perioperative neurocognitive disorders in older adults undergoing elective orthopedic procedures, particularly total hip arthroplasty. It is associated with adverse outcomes including increased morbidity, mortality, prolonged hospitalization, and long-term cognitive decline. Although international guidelines recommend routine preoperative cognitive assessment, its implementation in clinical practice remains limited.

This study builds on findings from a pilot project demonstrating the feasibility and potential predictive value of the ALBA test, a brief cognitive screening tool. The primary objective is to evaluate the association between ALBA test results (normal vs. pathological) and the occurrence of POD within 72 hours after surgery, diagnosed using the CAM-ICU instrument. Secondary objectives include assessing the relationship between POD and frailty (Clinical Frailty Scale), polypharmacy, comorbidities, preoperative anemia, type of anesthesia, intraoperative hemodynamic instability, blood loss, vasoactive medication use, reoperations, and postoperative complications.

The study is designed as a multicenter, prospective, non-interventional observational study conducted in seven hospitals in the Czech Republic. All participants will receive standard perioperative care without additional procedures or biological sampling. Cognitive screening (ALBA) will be performed during the pre-anesthetic assessment, and delirium monitoring (CAM-ICU) will be conducted at predefined intervals for up to 72 hours postoperatively. Data will be collected in REDCap and analyzed according to a predefined statistical analysis plan. The study also includes exploratory evaluation of the feasibility, acceptability, and implementation requirements of integrating the ALBA test into routine preoperative workflows.

Первичные конечные точки

• Incidence of postoperative delirium (POD) [Срок оценки: 0-72 hours after surgery]

Вторичные конечные точки (9)

• Frailty score measured using the Clinical Frailty Scale (CFS) [Срок оценки: Preoperative assessment]
• Number of comorbidities present preoperatively [Срок оценки: Preoperative assessment]
• Presence of polypharmacy (>5 regular medications) [Срок оценки: Preoperative medication list]
• Presence of preoperative anemia [Срок оценки: Preoperative assessment]
• Type of anesthesia used (general vs. regional) [Срок оценки: 0-72 hours after surgery]
• Duration of urinary catheterization (hours) [Срок оценки: 0-72 hours after surgery]
• Presence of reoperation within 72 hours after surgery [Срок оценки: 0-72 hours after surgery]
• Intraoperative blood loss (milliliters) [Срок оценки: Intraoperative period]
• Use of vasoactive drugs during surgery [Срок оценки: Intraoperative period]

Критерии участия

Критерии включения

• Age ≥ 65 years
• Elective total hip arthroplasty in general or regional anesthesia
• ASA physical status I-III
• Ability to understand and cooperate during testing; no severe sensory impairment (compensatory aids allowed)
• Expected postoperative hospitalization in ICU, PACU, or standard ward

Критерии исключения

• Glasgow Coma Scale ≤ 14
• Limited legal capacity
• Active psychiatric disorder (e.g., psychotic disorder, bipolar disorder)
• Active oncological disease
• Chronic use of strong opioids
• Premedication with anxiolytics or antipsychotics during preanesthetic evaluation
• Acute reoperation within 3 months of primary surgery
• Refusal to participate or withdrawal of consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Чехия · 7 центров

• University Hospital Brno - Bohunice — Brno
• University Hospital Olomouc - Department of Anaesthesiology, Resuscitation and Intensive C — Olomouc
• University Hospital Ostrava - Department of Anaesthesiology, Resuscitation and Intensive C — Ostrava
• University Hospital Královské Vinohrady — Prague
• University Hospital Motol — Prague
• Vsetín Hospital — Vsetín
• Tomas Bata Regional Hospital — Zlín

Идентификаторы

NCT: NCT07432009 · 2026-03-1 · ORTOPODCZ

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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