Retrospective Evaluation of POCD Data of Studies From KAI, Charité - Universitätsmedizin Berlin
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Postoperative Cognitive Dysfunction. Базовые параметры: 18 лет — 100 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Германия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Retrospective Evaluation of POCD Data of Studies From the Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK) Charité - Universitätsmedizin Berlin
Обзор
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.
Подробное описание
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 :
1. Describe cognitive change based on raw cognitive data from the applied cognitive test battery (computerized tests with CANTAB eclipse, CANTAB research suite, CANTAB connect and non-computerized tests) 2. Identify predisposing factors (e.g. patient characteristics, biomarkers, medications) predictive of cognitive decline following surgery 3. Identify the cognitive domains most sensitive to neuropsychological change following surgery
Subproject 2-Analyses will be performed in joint evaluation with Cambridge Cognition. The analyses aim to :
Facilitate the use of data collected from non-surgical controls as normative material for future studies in the research area.
Первичные конечные точки
- Neurocognitive Disorder (NCD) [Срок оценки: Up to 1 year]
- Postoperative cognitive dysfunction (POCD) [Срок оценки: Up to 1 year]
Вторичные конечные точки (12)
- Suspected neurocognitive disorder due to MiniCog [Срок оценки: Up to 5 years]
- Suspected dementia from MOCA [Срок оценки: Up to 5 years]
- Neurocognitive Disorder (NCD) [Срок оценки: Up to 5 years]
- Suspected postoperative neurocognitive disorder (mild / major NCD 'POCD') [Срок оценки: Up to 5 years]
- Findings from outpatient neurocognitive evaluation (memory clinic) [Срок оценки: Up to 1 year]
- Neuroimaging [Срок оценки: Up to 5 years]
- Normative database [Срок оценки: Up to 5 years]
- Perioperative cognitive disorders [Срок оценки: Up to 5 years]
- Computerized cognitive data [Срок оценки: Up to 5 years]
- Paper-based, non-computerized, cognitive test data [Срок оценки: Up to 5 years]
- Socio-economic Information 1 [Срок оценки: Up to 5 years]
- Socio-economic Information 2 [Срок оценки: Up to 5 years]
Критерии участия
Study Group
Критерии включения
- 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
Критерии исключения
- 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
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Германия · 2 центра
- Irmgard Landgraf — Berlin
- Department of Anesthesiology and Operative Intensive Care Medicine Berlin (CCM, CVK), Char — Berlin
Публикации
- Rasmussen LS, Larsen K, Houx P, Skovgaard LT, Hanning CD, Moller JT; ISPOCD group. The International Study of Postoperative Cognitive Dysfunction. The assessment of postoperative cognitive function. Acta Anaesthesiol Scand. 2001 Mar;45(3):275-89. doi: 10.1034/j.1399-6576.2001.045003275.x. PMID 11207462
- Evered L, Silbert B, Knopman DS, Scott DA, DeKosky ST, Rasmussen LS, Oh ES, Crosby G, Berger M, Eckenhoff RG; Nomenclature Consensus Working Group. Recommendations for the nomenclature of cognitive change associated with anaesthesia and surgery-2018. Br J Anaesth. 2018 Nov;121(5):1005-1012. doi: 10.1016/j.bja.2017.11.087. Epub 2018 Jun 15. PMID 30336844
Идентификаторы
NCT: NCT02832193 · POCD-Registry