Department of Anaesthesiolgy and Intensive Care Medicine CVK/CCM, Charité - Univeristy Medicine Berlin
Berlin, 13355, Germany
Location status: Recruiting
NCT Number: NCT05913531
Evaluation of several studies of the Clinic for Anesthesiology and Intensive Care Medicine CCM/CVK/CBF to create a register with the delirium data from anesthesiology study patients between 18 - 100 years. The primary purpose of the register is to assess factors influencing the development of delirium.
In a subproject, risk factors that may lead to the development of postoperative delirium in the elderly will be evaluated with regard to gender differences using patients from the age of 60 with different surgical procedures. The risk factors examined are based on the evidence-based and consensus-based recommendations of the ESA guideline and literature review. In addition, the delirium incidence rate and the delirium severity is examined regarding gender differences.
Interested in participating?
Request Info18 year–100 year
All sexes
Observational
Berlin, 13355, Germany
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Up to 5 years
Validated delirium scoring (points, duration and severity)
Time frame: Up to 5 years
Sedation is measured by the Richmond Agitation Sedation Scale
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 the Nikolaus-score (social situation), 1. Subscale
Time frame: Up to 5 years
Soci-economic information is collected by items on socioeconomic status from the Federal Health Survey of 1998
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 is measured by AUDIT (Alcohol Use Disorders Identification Tests)
Time frame: Up to 5 years
Consumption of 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
Consumption of nicotine is measured by Smocking Pack Years (SPY)
Time frame: Up to 5 years
Previous consumption of nicotine is measured by History of Smoking.
Time frame: Up to 5 years
Level of education is measured by ISCED (International Standard Classification of Education)
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
Quality of life is measured by SF-12 (Short form health survey)
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 (Patient Health Questionnaire depression scale)
Time frame: Up to 5 years
Depression 2 is measured by GDS (Geriatric Depression Scale)
Time frame: Up to 5 years
Depression 3 is measured by HADS (Hospital Anxiety and Depression Scale)
Time frame: Up to 5 years
Depression 4 is measured by CDS (Cornel Depression Scale)
Time frame: Up to 5 years
Anxiety is measured by GAD-7 (Generalized Anxiety Disorder 7)
Time frame: Up to 5 years
Anxiety 2 is measured by FAS (Faces Anxiety Scale)
Time frame: Up to 5 years
Anxiety 2 is measured by GAD-7
Time frame: Up to 5 years
Pain is measured by numeric pain scales (minimum = 0, maximum = 10).
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
Nutritional status 1 is measured by calf circumference
Time frame: Up to 5 years
Nutritional status 2 is measured by arm circumference
Time frame: Up to 5 years
Nutritional status 3 is measured by changes in weight
Time frame: Up to 5 years
Nutritional status 4 is measured by changes in body mass index
Time frame: Up to 5 years
Nutritional status 5 is measured by previous weight history (3 months)
Time frame: Up to 5 years
Nutritional status 6 is measured by Medi-Score
Time frame: Up to 5 years
Nutritional status 7 is measured by MNA-SF
Time frame: Up to 5 years
Nutritional status 8 is measured by Sarcopenia
Time frame: Up to 5 years
Nutritional status 9 is measured by Nutritional Risk Screening (NRS 2002)
Time frame: Up to 5 years
Nutritional status 10 is measured by AKE Screening
Time frame: Up to 5 years
Mobility 1 is measured with the Timed up and Go
Time frame: Up to 5 years
Mobility 2 is measured with a walking test: Slowness: Calculated after walking 3 meters, adjusted for sex and height, according to Fried. The cut-off points for 3 meters were established as, in men: height ≤173 cm and time ≥4.59 s (equivalent to 0.65 m/s); height >1.73 cm and time ≥3.93 s (equivalent to 0.76 m/s); and for women: height ≤1.59 cm and time ≥4.59 s (0.65 m/s); and height >1.59 cm and time ≥3.93 s (0.76 m/s).
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 liquor samples
Time frame: Up to 5 years
The sedation was measured intraoperatively processed electroencephalogram (EEG) Full-brain EEG recording with surface electrodes, raw EEG analysis measured during the operation.
Time frame: Up to 5 years
Type of operation is measured by OPS-Code
Time frame: Up to 5 years
Type of operation is measured in minutes
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
Duration of anesthesia is measured in minutes.
Time frame: Up to 5 years
Hospital stay is measured in days.
Time frame: Up to 5 years
Intensive care unit stay is measured in hours.
Time frame: Up to 5 years
Organ complications are recorded in hospital records
Time frame: Up to 5 years
Discharge criteria are measured at hospital discharge by Post Anesthetic Discharge Scoring System (PADS) Score
Time frame: Up to 5 years
Mortality rate is measured after 1,2,3,4 and 5 years
Time frame: Up to 5 years
Identification of study data with a high impact on delirium from the study databases
Time frame: Up to 5 years
Questions measuring personal satisfaction with sleep quality and duration As measured by questions measuring personal satisfaction with sleep quality and duration
Time frame: Up to 5 years
Items measuring circadian rhythm variables e.g. Zeitgebers
Time frame: Up to 5 years
Cognitive functioning will be measured with a battery of computerized neuropsychological tests.
Time frame: Up to 5 years
Cognitive functioning will be measured with a battery of non-computerized neuropsychological tests.
Time frame: Up to 5 years
Demographic data are documented in the hospital records.
Interested in participating?
Request InfoCharite University, Berlin, Germany
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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