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

NCT07432009 · tracked via the Priya Life Science Czechia tracker

Sponsor

Tomas Bata Hospital, Czech Republic

Phase

Observational

Started

2026-04-24

Last updated

2026-07-09

Condition(s) studied

FrailtyCognitive ImpairmentOlder AdultsHip ArthroplastyPostoperative Delirium

Study summary

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.

Eligibility

Sex

ALL

Min age

65 Years

Max age

—

Healthy volunteers

Accepted

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

Incidence of postoperative delirium (POD) — 0-72 hours after surgery
POD will be assessed using the CAM-ICU tool. Delirium is considered present if at least one CAM-ICU assessment is positive within the first 72 hours after surgery. The outcome will be expressed as the percentage of patients with POD.

Trial sites (7)

Facility	City	Region	Status
University Hospital Brno - Bohunice	Brno	Czechia	Not Yet Recruiting
University Hospital Olomouc - Department of Anaesthesiology, Resuscitation and Intensive Care	Olomouc	Czechia	Not Yet Recruiting
University Hospital Ostrava - Department of Anaesthesiology, Resuscitation and Intensive Care	Ostrava	Czechia	Not Yet Recruiting
University Hospital Královské Vinohrady	Prague	Czechia	Not Yet Recruiting
University Hospital Motol	Prague	Czechia	Not Yet Recruiting
Vsetín Hospital	Vsetín	Czechia	Not Yet Recruiting
Tomas Bata Regional Hospital	Zlín	Czechia	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07432009 on ClinicalTrials.gov ↗ ← All trials in Czechia