Orthopedic Procedures and Postoperative Delirium in Older Adults in the Czech Republic
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorTomas Bata Hospital, Czech Republic
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
Glasgow Coma Scale ≤ 14
Limited legal capacity
Active psychiatric disorder (e.g., psychotic disorder, bipolar disorder)
Active oncological disease
Trial population
Prospective cohort of patients aged 65 years and older undergoing elective total hip arthroplasty in seven hospitals in the Czech Republic. All participants receive standard perioperative care. No interventions are assigned as part of the study; only observational data are collected.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
400 Participants
are grouped into 1 trial groupGroup A: Cohort of older adults undergoing elective total hip arthroplasty
Trial outcomes
Primary outcomes
1
Incidence of postoperative delirium (POD)
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.
Time frame
0-72 hours after surgerySecondary outcomes
1
Frailty score measured using the Clinical Frailty Scale (CFS)
Frailty will be assessed preoperatively using the Clinical Frailty Scale (CFS), which ranges from 1 to 9. Frailty is defined as CFS ≥ 4. The outcome will be expressed as the frailty score on the CFS scale. Frailty will be assessed preoperatively using the Clinical Frailty Scale (CFS), which ranges from 1 to 9. Frailty is defined as CFS ≥ 4. The outcome will be expressed as the frailty score on the CFS scale.Frailty will be assessed preoperatively using the Clinical Frailty Scale (CFS), which ranges from 1 to 9. Frailty is defined as CFS ≥ 4. The outcome will be expressed as the frailty score on the CFS scale.
Time frame
Preoperative assessment2
Number of comorbidities present preoperatively
Comorbidities will be recorded preoperatively, including cerebrovascular disease, cardiovascular disease, diabetes mellitus, chronic kidney disease, and others. The outcome will be expressed as the total number of comorbidities per patient.
Time frame
Preoperative assessment3
Presence of polypharmacy (>5 regular medications)
Polypharmacy will be assessed preoperatively and defined as the regular use of more than five medications. The outcome will be expressed as the percentage of patients meeting the definition of polypharmacy.
Time frame
Preoperative medication list4
Presence of preoperative anemia
Anemia will be assessed preoperatively according to local laboratory reference ranges. The outcome will be expressed as the percentage of patients who meet the definition of anemia. Anemia will be assessed preoperatively according to local laboratory reference ranges. The outcome will be expressed as the percentage of patients who meet the definition of anemia.
Time frame
Preoperative assessmentSponsors and contacts
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Tomas Bata Hospital, Czech Republic
Lead sponsor
Czech Clinical Research Infrastructure Network
Collaborator
Source ClinicalTrials.gov