Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Medication history |
|
From date of inclusion until the date of the beginning of surgery, assessed up to 1 week |
|
Other |
Diabetic "yes"/"no" |
|
From date of inclusion until the date of the beginning of surgery, assessed up to 1 week day |
|
Other |
Mehrfachwahl-Wortschatztest Form A |
Intelligence is assessed using a multiple-choice vocabulary test (MWTA; Mehrfachwahl-Wortschatztest Form A). This test measures crystallized intelligence, which is the ability to use skill, knowledge, and experience and which relies on information from long-term memory. |
From date of inclusion until the date of the beginning of surgery, assessed up to 1 week |
|
Other |
Falls within last year |
|
From date of inclusion until the date of the beginning of surgery, assessed up to 1 week day |
|
Other |
Charlson Comorbidity index |
|
From date of inclusion until the date of the beginning of surgery, assessed up to 1 week |
|
Primary |
Incidence of postoperative cognitive dysfunction (POCD) |
Cognitive functioning will be measured with a battery of computerized neuropsychological tests, non-computerized and computer-based tests from the Cambridge Neuropsychological Test Automated Battery [CANTAB®] |
Up to 3 months |
|
Secondary |
Divided attention |
Divided attention will be measured in the pilot study with the Test of Attentional Performance - Mobility version (TAP-M), subtests divided attention and distractibility. |
Up to 3 months |
|
Secondary |
Incidence of postoperative delirium |
Postoperative delirium rate, defined according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V) and Chart Review |
Up to 7 days |
|
Secondary |
Intraoperative depth of sedation |
Intraoperative depth of sedation will be monitored in the pilot study with changes in the pattern off EEG-raw data measured with the Masimo SedLine® brain function monitoring for Root®. |
At time of surgery |
|
Secondary |
Depth of sedation on the Intensive Care Unit |
Depth of sedation will be measured in the pilot study with the Richmond Agitation Sedation Scale (RASS) |
Participants will be followed for the duration of intensive care unit stay, an expected average of 5 days |
|
Secondary |
Intraoperative cerebral oximetry |
Intraoperative cerebral oximetry will be measured in the pilot study by near-infrared spectroscopy (NIRS) developed for the Masimo Root® monitor. |
At time of surgery |
|
Secondary |
Quality of sleep |
Quality of sleep will be measured with the Insomnia Severity Index (ISI) |
Up to 3 months |
|
Secondary |
Anxiety |
Perioperative anxiety will be measured with the Faces Anxiety Scale (FAS) during hospital stay. |
Up to hospital discharge, an expected average of 7 days |
|
Secondary |
Intensive care unit length of stay |
|
Participants will be followed for the duration of intensive care unit stay, an expected average of 5 days |
|
Secondary |
Hospital length of stay |
|
Participants will be followed for the duration of hospital stay, an expected average of 7 days |
|
Secondary |
Evaluation of the cognitive training program RehaCom® by patient |
The evaluation will be measured with single items concerning patients' subjective rating of the quality of the training program, at least once during the week |
Up to 3 months |
|
Secondary |
Performance of cognitive training units of the program RehaCom® |
Data will be saved automatically by the computerized training program. The training performance will be measured as the highest level a patient has reached per training module, as well as number of mistakes within each level. |
Up to 3 months |
|
Secondary |
Duration of the cognitive training of the program RehaCom® |
Data will be saved automatically by the computerized training program. Duration will be measured as minutes per session and total sum of minutes of all sessions. |
Up to 3 months |
|
Secondary |
Frequency of the cognitive training of the program RehaCom® |
Data will be saved automatically by the computerized training program. Frequency will be measured as number of sessions and number of weeks with at least 1 session per week. |
Up to 3 months |
|
Secondary |
MRI assessment |
Functional MRI: Changes in neural activations in temporal and fronto-parietal brain regions during recognition in a face-name association task at baseline and three months after baseline assessment |
Up to 3 months |
|
Secondary |
MRI assessment |
Structural MRI: Changes in gray and white matter. |
Up to 3 months |
|
Secondary |
MRI assessment |
Functional MRI: Changes in neural activations in temporal and fronto-parietal brain regions during memory encoding at baseline and three months after baseline assessment |
Up to 3 months |
|
Secondary |
Barthel Activities of Daily Living (ADL) Index |
Functional Status will be assessed with the Barthel Activities of Daily Living (ADL) Index |
Up to 3 months |
|
Secondary |
Instrumented Activities of Daily Living (IADL) |
Functional Status will be assessed with the Instrumented Activities of Daily Living (IADL) scores |
Up to 3 months |
|
Secondary |
Frailty |
Frailty will be measured by modified Fried's criteria (Physical Frailty Phenotype) |
Up to 3 months |
|
Secondary |
Generalized anxiety |
|
Up to 3 months |
|
Secondary |
Depression |
Depression will be measured with the Patient Health Questionnaire 9-Item Scale (PHQ-9). |
Up to 3 months |
|
Secondary |
Quality of life |
Quality of life will be measured with a standardized instrument for use as a measure of health outcome EQ-5D |
Up to 3 months |
|
Secondary |
Routine laboratory |
No additional blood samples will be taken in the pilot study |
Up to hospital discharge, an expected average of 7 days |
|
Secondary |
Organ dysfunctions |
Organ dysfunctions are evaluated according to the Clavien-Dindo classification of surgical complications |
Up to hospital discharge, an expected average of 7 days |
|
Secondary |
Mortality |
Mortality is evaluated in the pilot study |
Up to three months |
|
Secondary |
Postoperative pain |
Postoperative pain will be measured with the Numeric Rating Scale (NRS-V) and validated scores |
Up to 3 months |
|
Secondary |
Mild cognitive impairment |
Mild cognitive impairment will be measured by impaired performance in neuropsychological testing (neurocognitive test battery), level of functionality (ADL, IADL) and self report on cognitive impairment (Metamemory and FEDA questionnaire) and related to performance in the MOCA cognitive screening tool. |
Up to 3 months |
|
Secondary |
Timed up and go test |
|
Up to 3 months |
|
Secondary |
Continence |
Measured by Deutscher Beckenboden-Fragebogen |
Up to 3 months |
|
Secondary |
Self report on cognitive deficits |
Fragebogen erlebter Defizite der Aufmerksamkeit (FEDA) |
Up to 3 months |
|
Secondary |
Metamemory |
Multifactorial Memory Questionnaire |
Up to 3 months |
|
Secondary |
Fatigue |
2 questions |
Up to 3 months |
|
Secondary |
Assessment on cognitive deficits by Proxy (IQCODE) |
Informant Questionnaire on Cognitive Decline in the Elderly |
Up to 3 months |
|
Secondary |
BIA (Bio-Impedanz-Analysis) |
|
Up to 3 months |
|
Secondary |
MNA Mini nutritional assessment-MNA short form) |
|
Up to 3 months |
|
Secondary |
Risk factors of dementia |
Risk factors of dementia are analysed by blood levels of APOE-4, BDNF, Kynurenine, Zonulin, Endocan and Tryptophan |
Up to 3 months |
|
Secondary |
Pro- und anti-inflammatory cytokines |
|
Up to 3 months |
|
Secondary |
micro-RNA |
|
Up to 3 months |
|