Orthopedic Procedures and Postoperative Delirium in the Czech Republic
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 7
- 主要终点
- Incidence of postoperative delirium (POD)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
结局指标
主要结局
Incidence of postoperative delirium (POD)
时间窗: 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.
次要结局
- Frailty score measured using the Clinical Frailty Scale (CFS)(Preoperative assessment)
- Number of comorbidities present preoperatively(Preoperative assessment)
- Presence of polypharmacy (>5 regular medications)(Preoperative medication list)
- Presence of preoperative anemia(Preoperative assessment)
- Type of anesthesia used (general vs. regional)(0-72 hours after surgery)
- Duration of urinary catheterization (hours)(0-72 hours after surgery)
- Presence of reoperation within 72 hours after surgery(0-72 hours after surgery)
- Intraoperative blood loss (milliliters)(Intraoperative period)
- Use of vasoactive drugs during surgery(Intraoperative period)
研究者
Klára Nekvindová
Principal Investigator, Department of Anesthesiology, Resuscitation and Intensive Car
Tomas Bata Hospital, Czech Republic