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Orthopedic Procedures and Postoperative Delirium in the Czech Republic

Status: Recruiting
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: t
View:

• 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

Contact Information
Primary
Klára Nekvindová, M.D, Ph.D.
nekvindova.klara@gmail.com
+420577 551 111
Time Frame
Start Date: 2026-04-24
Estimated Completion Date: 2030-03-31
Participants
Target number of participants: 400
Treatments
Cohort of older adults undergoing elective total hip arthroplasty
Prospective cohort of patients aged 65 years and older undergoing elective total hip arthroplasty in standard clinical care. All participants receive routine perioperative management. No interventions are assigned as part of the study.
Related Therapeutic Areas
Sponsors
Collaborators: Czech Clinical Research Infrastructure Network
Leads: Tomas Bata Hospital, Czech Republic

This content was sourced from clinicaltrials.gov