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| ID | Type | Description | Link |
|---|---|---|---|
| ORTOPODCZ | Other Identifier | Tomas Bata regional hospital |
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| Name | Class |
|---|---|
| Czech Clinical Research Infrastructure Network | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0-72 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Klára Nekvindová, M.D, Ph.D. | Contact | +420577 551 111 | nekvindova.klara@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Brno - Bohunice | Not yet recruiting | Brno | 62500 | Czechia |
Individual participant data (IPD) will not be shared because this is a multicenter observational study conducted under strict GDPR requirements. The study does not include a data-sharing framework or governance structure that would allow external access to pseudonymized datasets. Data will be used exclusively for the purposes defined in the study protocol and handled according to institutional and national data protection regulations.
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| ID | Term |
|---|---|
| D000073496 | Frailty |
| D060825 | Cognitive Dysfunction |
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
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| Preoperative assessment |
| 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. | Preoperative assessment |
| 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. | Preoperative medication list |
| 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. | Preoperative assessment |
| Type of anesthesia used (general vs. regional) | 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. | 0-72 hours after surgery |
| Duration of urinary catheterization (hours) | 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. | 0-72 hours after surgery |
| Presence of reoperation within 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. | 0-72 hours after surgery |
| Intraoperative blood loss (milliliters) | 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. | Intraoperative period |
| Use of vasoactive drugs during surgery | 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. | Intraoperative period |
| University Hospital Olomouc - Department of Anaesthesiology, Resuscitation and Intensive Care | Not yet recruiting | Olomouc | 77900 | Czechia |
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| University Hospital Ostrava - Department of Anaesthesiology, Resuscitation and Intensive Care | Not yet recruiting | Ostrava | Czechia |
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| University Hospital Královské Vinohrady | Not yet recruiting | Prague | 10034 | Czechia |
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| University Hospital Motol | Not yet recruiting | Prague | 15006 | Czechia |
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| Vsetín Hospital | Not yet recruiting | Vsetín | Czechia |
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| Tomas Bata Regional Hospital | Recruiting | Zlín | 6275 | Czechia |
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| D001523 | Mental Disorders |
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011183 | Postoperative Complications |
| D012816 | Signs and Symptoms |