Cognitive Impairment, Frailty, Hip Arthroplasty, Older Adults, Postoperative Delirium
Conditions
Keywords
ALBA test, CAM-ICU, Cognitive Screening, Geriatric Patients, Perioperative Neurocognitive Disorders, Polypharmacy, Clinical Frailty Scale, Total Hip Replacement, Observational Study, Prospective Cohort
Brief 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.
Detailed description
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.
Interventions
None listed
Sponsors
Tomas Bata Hospital, Czech Republic
Czech Clinical Research Infrastructure Network
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frailty score measured using the Clinical Frailty Scale (CFS) | Preoperative assessment | 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. |
| Number of comorbidities present preoperatively | Preoperative assessment | 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. |
| Presence of polypharmacy (>5 regular medications) | Preoperative medication list | 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. |
| Presence of preoperative anemia | Preoperative assessment | 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. |
| Type of anesthesia used (general vs. regional) | 0-72 hours after surgery | The type of anesthesia will be recorded as general anesthesia or regional anesthesia. The outcome will be expressed as the percentage of patients receiving each anesthesia type. |
| Duration of urinary catheterization (hours) | 0-72 hours after surgery | The duration of urinary catheterization (PMK) will be recorded daily from surgery until catheter removal. The outcome will be expressed as the total number of hours of urinary catheterization. |
| Presence of reoperation within 72 hours after surgery | 0-72 hours after surgery | Reoperation will be assessed as a binary variable (yes/no) within 72 hours after surgery. The outcome will be expressed as the percentage of patients who undergo reoperation. |
| Intraoperative blood loss (milliliters) | Intraoperative period | ntraoperative blood loss will be measured in milliliters as recorded by the surgical team. The outcome will be expressed as the total volume of blood loss during surgery. |
| Use of vasoactive drugs during surgery | Intraoperative period | The use of vasoactive drugs (e.g., noradrenaline, phenylephrine, ephedrine) will be assessed as a binary variable (yes/no) during the intraoperative period. The outcome will be expressed as the percentage of patients who receive vasoactive drugs. |
Countries
Czechia
Contacts
CONTACTKlára Nekvindová, M.D, Ph.D.
Outcome results
None listed