Retrospective Evaluation of POCD Data of Studies From the Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK) Charité - Universitätsmedizin Berlin
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 2
- 主要终点
- Neurocognitive Disorder (NCD)
研究概览
简要总结
Data on prevention of perioperative neurocognitive disorders (pNCDs) are limited. The purpose of this monocentric parallel - grouped observational registry is to collect study data from studies with pNCDs as primary or secondary endpoint to estimate prevalence and incidence of pNCDs.
详细描述
Perioperative cognitive trajectories (Perioperative neurocognitive disorders [pNCDs]) are described with formal cognitive testing (neurocognitive test battery). Definitions are based on current nomenclature recommendations (Evered et al.) according to DSM-V criteria including a multi-component cognitive test battery comparing baseline and postoperative follow-up testing of patients with cognitive test performance of non-surgical control groups.Cognitive concern and functional ability are described with items from questionnaires, e.g. IQCODE, MMQ, GDS, ADL/IADL and others specific to the respective study design.
Repeated cognitive testing with a battery of computerized neuropsychological tests (Cambridge Neuropsychological Test Automated Battery [CANTAB®]) and non computerized (paper based)tests (e.g. trailmaking test, Grooved pegboard test, Stroop color word interference test, animal naming test, etc.) are performed at preoperative baseline, after 5-7 days and at three months follow up, 1 year, 2 years and 5 years follow-up according to the study design of the registered studies.
Different calculation methods will be applied to the cognitive test data, primarily the dichotomousapproach established by Rasmussen et al. in the International Study on postoperative cognitive deficits (ISPOCD). This calculation method defines POCD as a reliable change in pre- and postoperative cognitive performance (difference scores) of each individual in the surgical patients cohort as compared to the changes in a non-surgical control group (reliable change index in either a composite score including cognitive test parameters from all tests in the cognitive test battery or in at least two of the chosen cognitive test parameters). Additional calculation methods like "g-factor", "GCP" and arbitrary definitions e.g. "20.20- rule" will be used for detailed methodologic evaluation.
In two subprojects we plan to describe domain-specific changes in formal cognitive testing over the registered surgical cohorts.
Subproject 1-Analyses will be performed in joint evaluation with Monument Therapeutics (Spin off Cambridge Cognition). The analyses aim to :
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
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 -100 years
- •Male or female patients undergoing elective surgery expected to last at least 60 min, screened at the Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, Berlin, Germany
- •Written informed consent to participate after having been properly instructed
排除标准
- •Lacking willingness to take part in the study, or to have relevant study data collected, saved and analyzed for the purpose of the study
- •Accommodation in an institution due to an official or judicial order
- •Insufficient knowledge of German language
- •Members of the hospital staff
- •Homelessness or other conditions that disable reachability for postoperative assessment by post or telephone
- •Illiteracy
- •Patients who had a history of neurologic deficits (e.g. stroke, history of seizures, etc.)
- •Hearing impairment that severely affects the neuropsychological testing.
- •Visual impairment that severely affects the neuropsychological testing.
- •Participation in other prospective clinical interventional trials
- •Control Group
- •Inclusion Criteria:
- •Age 18 - 100 years
- •Male or female patients (ASA Status I, II+III)
- •No planned surgery during the next 3 months
- •No surgery during the past 6 months before study inclusion
- •Written informed consent to participate after having been properly instructed
- •Exclusion Criteria:
- •Insufficient knowledge of German language Lacking willingness to take part in the study, or to have relevant study data collected, saved and analyzed for the purpose of the study
- •Neuropsychiatric conditions that severely affect the neuropsychological testing
- •Hearing impairment that severely affects the neuropsychological testing
- •Visual impairment that severely affects the neuropsychological testing
结局指标
主要结局
Neurocognitive Disorder (NCD)
时间窗: Up to 1 year
Mild / major neurocognitive disorder 3 (mild / major NCD 'Postoperative cognitive dysfunction (POCD)') and 12 months (mild / major NCD) postoperatively.
Postoperative cognitive dysfunction (POCD)
时间窗: Up to 1 year
Postoperative cognitive dysfunction (POCD) is defined as relevant change in postoperative cognitive performance compared to baseline (preoperative) cognitive performance.
次要结局
- Findings from outpatient neurocognitive evaluation (memory clinic)(Up to 1 year)
- Severity of postoperative delirium 3(Up to 5 years)
- Nutritional status 4(Up to five years)
- Lifestyle Risks 1(Up to 5 years)
- Nutritional status 7(Up to five years)
- Severity of postoperative delirium 1(Up to 5 years)
- Lifestyle Risks 2(Up to 5 years)
- Normative database(Up to 5 years)
- Perioperative cognitive disorders(Up to 5 years)
- Computerized cognitive data(Up to 5 years)
- Paper-based, non-computerized, cognitive test data(Up to 5 years)
- Socio-economic Information 1(Up to 5 years)
- Socio-economic Information 2(Up to 5 years)
- Quality of life - relatives(Up to 5 years)
- Level of education(Up to 5 years)
- Duration of postoperative delirium(Up to 5 years)
- Severity of postoperative delirium 2(Up to 5 years)
- Neurocognitive Disorder (NCD)(Up to 5 years)
- Neuroimaging(Up to 5 years)
- Incidence of postoperative delirium(Up to 5 years)
- Suspected neurocognitive disorder due to MiniCog(Up to 5 years)
- Suspected dementia from MOCA(Up to 5 years)
- Suspected postoperative neurocognitive disorder (mild / major NCD 'POCD')(Up to 5 years)
- Comorbidities(Up to 5 years)
- Charlson comorbidity index(Up to 5 years)
- Severity of postoperative delirium 4(Up to 5 years)
- Severity of postoperative delirium 5(Up to 5 years)
- Length of hospital stay(Up to 5 years)
- Functional impairment (ADL) 2(Up to 5 years)
- Anxiety scales(Up to 5 years)
- Quality of life - self 1(Up to 5 years)
- Functional impairment (IADL) 1(Up to 5 years)
- Sedation(Up to 5 years)
- Type of operation(Up to 5 years)
- Quality of life - self 2(Up to 5 years)
- Depression 1(Up to 5 years)
- Depression 2(Up to 5 years)
- Pain(Up to 5 years)
- Depth of sedation(Up to 5 years)
- Type of concomitant medication(Up to 5 years)
- Anticholinergic Load(Up to 5 years)
- Type of anesthesia(Up to 5 years)
- Nutritional status 2(Up to five years)
- Frailty(Up to 5 years)
- Nutritional status 1(Up to five years)
- Number of participants with changes in laboratory values 1(Up to 5 years)
- Number of participants with changes in laboratory values 2(Up to 5 years)
- Number of participants with changes in laboratory values 3(Up to 5 years)
- Number of participants with changes in laboratory values 4(Up to 5 years)
- Perioperative Electroencephalography(During hospital stay an expected avarage of 7 days)
- Nutritional status 3(Up to five years)
- Nutritional status 5(Up to five years)
- Nutritional status 6(Up to five years)
- Eating habits(Up to five years)
- Nutritional status 8(Up to five years)
- Inhospital diet(Up to five years)
研究者
Claudia Spies
Head of the Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK)
Charite University, Berlin, Germany