Cognitive Dysfunction and Delirium After TUR-M in Elderly Patients
NCT07719712
Cognition Disorders, Cognitive Dysfunction
Muğla, Turkey (Türkiye)
View Trial DetailsNCT Number: NCT02832193
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.
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Request Info18 year–100 year
All sexes
Observational
Department of Anesthesiology and Operative Intensive Care Medicine Berlin (CCM, CVK), Charité - Universitätsmedizin Berlin, Berlin, Germany
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 :
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Study Group
Inclusion criteria
Exclusion criteria
Control Group
Inclusion criteria
Exclusion criteria
Time frame: Up to 1 year
Mild / major neurocognitive disorder 3 (mild / major NCD 'Postoperative cognitive dysfunction (POCD)') and 12 months (mild / major NCD) postoperatively.
Time frame: Up to 1 year
Postoperative cognitive dysfunction (POCD) is defined as relevant change in postoperative cognitive performance compared to baseline (preoperative) cognitive performance.
Time frame: Up to 5 years
The MiniCog is used for cognitive screening. A cut-off value of <3 points is interpreted possible mild / major NCD. The Mini-Cog consists of a sub-test for word memory skills and a clock drawing test.
Time frame: Up to 5 years
The Montreal Cognitive Assessment (MOCA) with cut-offs according to normative age-adjusted values is used as dementia screening. The MOCA consists of 13 items, which are rated on a scale from 0 to 30 points.
Time frame: Up to 5 years
Mild / major neurocognitive disorder (mild / major NCD) 60months postoperatively.
Time frame: Up to 5 years
The non-computerized neuropsychological trail making test is used as an indicator screening test for relevant cognitive changes after the operation. The cut-off is an increase in TMT-B test performance of> 55 seconds three and / or 12 months after the operation compared to the baseline value.
Time frame: Up to 1 year
Results from patient neurocognitive assessment in a memory clinic are evaluated.
Time frame: Up to 5 years
Technique to image the nervous system.
Time frame: Up to 5 years
Establishment of a norm database for deriving normative data in a cooperation between the Clinial Research Unit Berlin/Institute of Health (BIH), the Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK) at Charité Universitätsmedizin Berlin and Cambridge Cognition.
Time frame: Up to 5 years
Perioperative cognitive disorders for different surgical cohorts are evaluated to describe domain-specific changes over time in formal cognitive tests. These analyzes are carried out in a joint evaluation with Monument Therapeutics as part of a cooperation agreement
Time frame: Up to 5 years
Computerized cognitive data from CANTAB-research suite, CANTAB eclipse and CANTAB connect
Time frame: Up to 5 years
Paper-based, non-computerized, cognitive test data are data from such as IQ equivalent (e.g. MWT-A), MMSE, MOCA, MMQ, Mini-Cog, etc.
Time frame: Up to 5 years
Soci-economic information is collected by FIMA
Time frame: Up to 5 years
Soci-economic information is collected by a questionnaire according to Nikolaus 1. Subscale
Time frame: Up to 5 years
Comorbidities are new diagnoses from hospital records.
Time frame: Up to 5 years
Comorbidity scores
Time frame: Up to 5 years
Consumption of alcohol per week.
Time frame: Up to 5 years
Consumption of tobacco and nicotine is measured by Fagerström Test for Cigarette Dependence (FTCD). Questionnaire scored 0-10 points with Total Score equal to the sum of all points
Time frame: Up to 5 years
Level of education is measured by ISCED
Time frame: Up to 5 years
Incidence of postoperative delirium is measured by DDS, DSM-V, CAM/CAM-ICU, NuDESC and Chart review
Time frame: Up to 5 years
The Duration of postoperative Delirium is measured in days
Time frame: Up to 5 years
Severity of delirium 1 is measured by Delirium Detection Score (DDS). The DDS is composed of eight criteria (orientation, hallucination, agitation, anxiety, seizures, tremor, paroxysmal sweating, and altered sleep- wake rhythm). Each item is cored 0,1,4, or 7 points for a possible total score of 0 to 56). Positive if >7.
Time frame: Up to 5 years
Severity of delirium 2 is measured by Confusion assessment method-short (CAM-S). This is a CAM-based scoring system for delirium severity. The CAM-S uses the same items as the original CAM and rates each symptom 0 for absent, 1 for mild, or 2 for marked; acute onset of fluctuation receives 0 (absent) or 1 (present) (scored 0-10, higher worse).
Time frame: Up to 5 years
Severity of delirium 3 is measured by DSR-R-98. DRS-R-98 is 16 items clinician rated scale. Total Item: 16 = 3 (for diagnosis) + 13 (for severity).
Time frame: Up to 5 years
Severity of delirium 4 is measured by ICDSC. Give a score of "1" to each of the 8 items below if the patient clearly meets the criteria defined in the scoring instructions. Give a score of "0" if there is no manifestation orunable to score. If the patient scores >4, notify the physician. The diagnosis of delirium is made following clinical assessment. assessment.
Time frame: Up to 5 years
Severity of delirium 5 is measured by Nursing Delirium Screening Scale (Nu-DESC). The Nu-DESC is a scale that evaluates the severity of the 5 delirium characteristics on a scale of 0 (not present) to 2 (severe) and takes only 1-2 min to complete, based on the nurses' observations of the patient's behavior during their shifts.
Time frame: Up to 5 years
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Time frame: Up to 5 years
Quality of life is measured by CarerQoL
Time frame: Up to 5 years
Quality of life is measured by EQ-5D.An index calculated from the five EQ-5D (3L and 5L) dimensions by attaching specific weights to each severity level in each dimension.
Time frame: Up to 5 years
Quality of life is measured by WHO-5. WHO-5 is a short and generic global rating scale measuring subjective well-being, the respondent is asked to rate how well each of the 5 statements applies to him or her when considering the last 14 days. Each of the 5 items is scored from 5 (all of the time) to 0 (none of the time). The raw score ranges from 0 (absence of well-being) to 25 (maximal well-being). Scores are then converted to a percentage scale from 0 (absent) to 100 (maximal). Higher scores represent greater psychological well-being.
Time frame: Up to 5 years
Instrumental Activities of Daily Living (IADLs) < 8
Time frame: Up to 5 years
Activities of Daily Living (ADLs) < 100
Time frame: Up to 5 years
Depression 1 is measured by PHQ-8
Time frame: Up to 5 years
Depression 2 is measured by GDS
Time frame: Up to 5 years
Anxiety is measured by GAD-7
Time frame: Up to 5 years
Pain is measured by different scales, e.g. Numeric Rating Scale
Time frame: Up to 5 years
The sedation is emasured intraoperatively processed electroencephalogram (EEG) Full-brain EEG recording with surface electrodes, raw EEG analysis measured during the operation.
Time frame: Up to 5 years
Sedation is measured by the Richmond Agitation Sedation Scale
Time frame: Up to 5 years
Type of operation is measured by OPS-Code.
Time frame: Up to 5 years
There are four main categories of anesthesia used during surgery and other procedures: general anesthesia, regional anesthesia, sedation (sometimes called "monitored anesthesia care"), and local anesthesia.
Time frame: Up to 5 years
The medication administered during the hospital stay is documented.
Time frame: Up to 5 years
Measured by anticholinergic drug scale
Time frame: Up to 5 years
Frailty is measured with a modified frailty score according to Fried´s frailty phenotype assessment.
Time frame: Up to 5 years
Laboratory results in the hospital including hemoglobin, lymphocytes, total neutrophils, platelet count, white blood cell (WBC) count and inflammatory markers from blood samples.
Time frame: Up to 5 years
Laboratory results in the hospital from serum samples
Time frame: Up to 5 years
Laboratory results in the hospital from urine samples
Time frame: Up to 5 years
Laboratory results in the hospital from stool samples
Time frame: During hospital stay an expected avarage of 7 days
Electroencephalography (EEG)- Mapping with electrodes.
Time frame: Up to five years
Nutritional status 1 is measured by calf circumference
Time frame: Up to five years
Nutritional status 2 is measured by arm circumference
Time frame: Up to five years
Nutritional status 3 is measured by changes in weight
Time frame: Up to five years
Nutritional status 4 is measured by changes in body mass index
Time frame: Up to five years
Nutritional status 5 is measured by questions regarding microbiome
Time frame: Up to five years
Nutritional status 6 is measured by Medi-Score
Time frame: Up to five years
Nutritional status 7 is measured by MNA-SF
Time frame: Up to five years
Nutritional status 8 is measured by Sarcopenia, which is identified by criterion 1: low muscle strength, criterion 2: low muscle quantity and criterion 3: low physical performance. Probable sarcopenia is identified by Criterion 1. Diagnosis is confirmed by additional documentation of Criterion 2.
If Criteria 1, 2 and 3 are all met, sarcopenia is considered severe.
Time frame: Up to five years
Inhospital diet is measured by patient record.
Time frame: Up to five years
Eating habits are measured by patient survey.
Time frame: Up to 5 years
Demographics are measured by demographic data.
Time frame: Up to 5 years
Neurological diseases are taken from the hospital record
Time frame: Up to 5 years
Waist circumference is measured in cm.
Time frame: Up to 5 years
Hip circumference is measured in cm.
Time frame: Up to 5 years
Obesitas is measured by body mass index.
Time frame: At Baseline
Metamemory Questionnaire (MMQ) contentment scale is a participant-reported measure of memory satisfaction, ability, and strategy use..
Time frame: At Baseline
Presurgical cognitive impairment is determined as cognitive performance of a test battery.
Contact information is provided by the study sponsor or research team.
Charite University, Berlin, Germany
Other
Retrospective Evaluation of POCD Data of Studies From the Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK) Charité - Universitätsmedizin Berlin
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