Retrospective Evaluation of Delirium Data From Previous Study Patients for Studies at the Clinic for Anesthesiology and Intensive Care Medicine CCM/CVK/CBF
Study Details
Study Description
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 sex 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 (Aldecoa et al., 2017) and literature review. In addition, the delirium incidence rate and the delirium severity is examined regarding sex differences.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- Delirium [Up to 5 years]
Validated delirium scoring (points, duration and severity)
Secondary Outcome Measures
- Sedation scales [Up to 5 years]
Sedation is measured by the Richmond Agitation Sedation Scale
- Socioeconomic information 1 [Up to 5 years]
Soci-economic information is collected by FIMA
- Socioeconomic information 2 [Up to 5 years]
Soci-economic information is collected by a questionnaire according to Nikolaus 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
- Comorbidities [Up to 5 years]
Comorbidities are new diagnoses from hospital records.
- Charlson comorbidity index [Up to 5 years]
Comorbidity scores
- Lifestyle risks 1 [Up to 5 years]
Consumption of alcohol is measured by AUDIT (Alcohol Use Disorders Identification Tests)
- 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
- Lifestyle risks 3 [Up to 5 years]
Consumption of nicotine is measured by Smocking Pack Years (SPY)
- Lifestyle risks 4 [Up to 5 years]
Previous consumption of nicotine is measured by History of Smoking.
- Level of education [Up to 5 years]
Level of education is measured by ISCED (International Standard Classification of Education)
- 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.
- 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)
- Functional impairment (IADL) 1 [Up to 5 years]
Instrumental Activities of Daily Living (IADLs) < 8
- Functional impairment (ADL) 2 [Up to 5 years]
Activities of Daily Living (ADLs) < 100
- Depression 1 [Up to 5 years]
Depression 1 is measured by PHQ-8 (Patient Health Questionnaire depression scale)
- Depression 2 [Up to 5 years]
Depression 2 is measured by GDS (Geriatric Depression Scale)
- 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)
- Anxiety scales 1 [Up to 5 years]
Anxiety is measured by GAD-7 (Generalized Anxiety Disorder 7)
- Anxiety scale 2 [Up to 5 years]
Anxiety 2 is measured by FAS (Faces Anxiety Scale)
- Anxiety scale 2 [Up to 5 years]
Anxiety 2 is measured by GAD-7
- Pain [Up to 5 years]
Pain is measured by numeric pain scales (minimum = 0, maximum = 10).
- Type of concomitant medication [Up to 5 years]
The medication administered during the hospital stay is documented.
- Anticholinergic Load [Up to 5 years]
Measured by anticholinergic drug scale
- Frailty [Up to 5 years]
Frailty is measured with a modified frailty score according to Fried´s frailty phenotype assessment.
- Nutritional status 1 [Up to 5 years]
Nutritional status 1 is measured by calf circumference
- 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 4 [Up to 5 years]
Nutritional status 4 is measured by changes in body mass index
- Nutritional status 5 [Up to 5 years]
Nutritional status 5 is measured by previous weight history (3 months)
- Nutritional status 6 [Up to 5 years]
Nutritional status 6 is measured by Medi-Score
- Nutritional status 7 [Up to 5 years]
Nutritional status 7 is measured by MNA-SF
- Nutritional status 8 [Up to 5 years]
Nutritional status 8 is measured by Sarcopenia
- Nutritional status 9 [Up to 5 years]
Nutritional status 9 is measured by Nutritional Risk Screening (NRS 2002)
- Nutritional status 10 [Up to 5 years]
Nutritional status 10 is measured by AKE Screening
- Mobility 1 [Up to 5 years]
Mobility 1 is measured with the Timed up and Go
- 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).
- 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
- Number of participants with changes in laboratory values 3 [Up to 5 years]
Laboratory results in the hospital from urine samples
- Number of participants with changes in laboratory values 4 [Up to 5 years]
Laboratory results in the hospital from liquor samples
- Depth of sedation [During surgery, an expected average of 4 hours]
The sedation was measured intraoperatively processed electroencephalogram (EEG) Full-brain EEG recording with surface electrodes, raw EEG analysis measured during the operation.
- Type of operation [During surgery, an expected average of 4 hours]
Type of operation is measured by OPS-Code
- Duration of operation [During surgery, an expected average of 4 hours]
Type of operation is measured in minutes
- Type of anesthesia [During surgery, an expected average of 4 hours]
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.
- Duration of anesthesia [During surgery, an expected average of 4 hours]
Duration of anesthesia is measured in minutes.
- Length of hospital stay [Participants will be followed for the duration of hospital stay, an expected average of 7 days]
Hospital stay is measured in days.
- Intensive care unit stay [Participants will be followed for the duration of intensive care unit stay, an expected average of 2 days]
Intensive care unit stay is measured in hours.
- Organ complications [Participants will be followed for the duration of hospital stay, an expected average of 7 days]
Organ comlications are recorded in hospital records
- Hospital discharge criteria [Participants will be followed for the duration of hospital stay, an expected average of 7 days]
Discharge criteria are measured at hospital discharge by Post Anesthetic Discharge Scoring System (PADS) Score
- Mortality [Up to 5 years]
Mortality rate is measured after 1,2,3,4 and 5 years
- Study data [Up to 5 years]
Identification of study data with a high impact on delirium from the study databases
Other Outcome Measures
- Parameter of cognition [Up to five years]
Cognitive functioning will be measured with a battery of computerized neuropsychological tests.
- Parameter of cognition [Up to five years]
Cognitive functioning will be measured with a battery of non-computerized neuropsychological tests.
- Demographic data [Up to five years]
Demographic data are documented in the hospital records.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Male and female patients age ≥ 18 years of studies of the clinic for Anesthesiology and Intensive Care Medicine CCM/CVK/CBF
Exclusion Criteria:
- None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Anaesthesiolgy and Intensive Care Medicine CVK/CCM, Charité - Univeristy Medicine Berlin | Berlin | Germany | 13355 |
Sponsors and Collaborators
- Charite University, Berlin, Germany
Investigators
- Study Director: Claudia Spies, MD, Prof., Charite University, Berlin, Germany
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Retro-Delirium