Retrospective Evaluation of Delirium Data From Previous Study Patients for Studies at the Clinic for Anesthesiology and Intensive Care Medicine CCM/CVK/CBF
- Conditions
- Delirium
- Registration Number
- NCT05913531
- Lead Sponsor
- Charite University, Berlin, Germany
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 5000
- Male and female patients age ≥ 18 years of studies of the clinic for Anesthesiology and Intensive Care Medicine CCM/CVK/CBF
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Delirium Up to 5 years Validated delirium scoring (points, duration and severity)
- Secondary Outcome Measures
Name Time Method Socioeconomic information 2 Up to 5 years Soci-economic information is collected by the Nikolaus-score (social situation), 1. Subscale
Socioeconomic information 3 Up to 5 years Soci-economic information is collected by items on socioeconomic status from the Federal Health Survey of 1998
Lifestyle risks 1 Up to 5 years Consumption of alcohol is measured by AUDIT (Alcohol Use Disorders Identification Tests)
Lifestyle risks 3 Up to 5 years Consumption of nicotine is measured by Smocking Pack Years (SPY)
Depression 2 Up to 5 years Depression 2 is measured by GDS (Geriatric Depression Scale)
Anxiety scales 1 Up to 5 years Anxiety is measured by GAD-7 (Generalized Anxiety Disorder 7)
Nutritional status 1 Up to 5 years Nutritional status 1 is measured by calf circumference
Nutritional status 4 Up to 5 years Nutritional status 4 is measured by changes in body mass index
Duration of operation Up to 5 years Type of operation is measured in minutes
Anticholinergic Load Up to 5 years Measured by anticholinergic drug scale
Nutritional status 5 Up to 5 years Nutritional status 5 is measured by previous weight history (3 months)
Nutritional status 7 Up to 5 years Nutritional status 7 is measured by MNA-SF
Intensive care unit stay Up to 5 years Intensive care unit stay is measured in hours.
Mortality Up to 5 years Mortality rate is measured after 1,2,3,4 and 5 years
Type of concomitant medication Up to 5 years The medication administered during the hospital stay is documented.
Socioeconomic information 1 Up to 5 years Soci-economic information is collected by FIMA
Quality of life - relatives Up to 5 years Quality of life is measured by CarerQoL
Quality of life - self 1 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.
Depression 1 Up to 5 years Depression 1 is measured by PHQ-8 (Patient Health Questionnaire depression scale)
Length of hospital stay Up to 5 years Hospital stay is measured in days.
Study data Up to 5 years Identification of study data with a high impact on delirium from the study databases
Sedation scales Up to 5 years Sedation is measured by the Richmond Agitation Sedation Scale
Frailty Up to 5 years Frailty is measured with a modified frailty score according to Fried´s frailty phenotype assessment.
Comorbidities Up to 5 years Comorbidities are new diagnoses from hospital records.
Charlson comorbidity index Up to 5 years Comorbidity scores
Lifestyle risks 4 Up to 5 years Previous consumption of nicotine is measured by History of Smoking.
Functional impairment (ADL) 2 Up to 5 years Activities of Daily Living (ADLs) \< 100
Anxiety scale 2 Up to 5 years Anxiety 2 is measured by GAD-7
Number of participants with changes in laboratory values 4 Up to 5 years Laboratory results in the hospital from liquor samples
Organ complications Up to 5 years Organ complications are recorded in hospital records
Lifestyle risks 2 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
Level of education Up to 5 years Level of education is measured by ISCED (International Standard Classification of Education)
Functional impairment (IADL) 1 Up to 5 years Instrumental Activities of Daily Living (IADLs) \< 8
Pain Up to 5 years Pain is measured by numeric pain scales (minimum = 0, maximum = 10).
Nutritional status 9 Up to 5 years Nutritional status 9 is measured by Nutritional Risk Screening (NRS 2002)
Duration of anesthesia Up to 5 years Duration of anesthesia is measured in minutes.
Quality of life - self 2 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.
Quality of life - self 3 Up to 5 years Quality of life is measured by SF-12 (Short form health survey)
Depression 3 Up to 5 years Depression 3 is measured by HADS (Hospital Anxiety and Depression Scale)
Depression 4 Up to 5 years Depression 4 is measured by CDS (Cornel Depression Scale)
Nutritional status 2 Up to 5 years Nutritional status 2 is measured by arm circumference
Nutritional status 3 Up to 5 years Nutritional status 3 is measured by changes in weight
Nutritional status 6 Up to 5 years Nutritional status 6 is measured by Medi-Score
Nutritional status 8 Up to 5 years Nutritional status 8 is measured by Sarcopenia
Mobility 1 Up to 5 years Mobility 1 is measured with the Timed up and Go
Number of participants with changes in laboratory values 1 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.
Number of participants with changes in laboratory values 2 Up to 5 years Laboratory results in the hospital from serum samples
Type of operation Up to 5 years Type of operation is measured by OPS-Code
Number of participants with changes in laboratory values 3 Up to 5 years Laboratory results in the hospital from urine samples
Depth of sedation 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.
Nutritional status 10 Up to 5 years Nutritional status 10 is measured by AKE Screening
Mobility 2 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).
Hospital discharge criteria Up to 5 years Discharge criteria are measured at hospital discharge by Post Anesthetic Discharge Scoring System (PADS) Score
Sleeping items 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
Circadian rhythm variables Up to 5 years Items measuring circadian rhythm variables e.g. Zeitgebers
Type of anesthesia 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.
Trial Locations
- Locations (1)
Department of Anaesthesiolgy and Intensive Care Medicine CVK/CCM, Charité - Univeristy Medicine Berlin
🇩🇪Berlin, Germany