F05.0 F05.1
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Elective surgery (heart, thorax, vessels, proximal big joints and spinal cord, genitourinary, gastrointestinal and general elective surgery procedures) with at least 60 minutes duration of surgery (cut-to-suture-time).
Exclusion criteria
Exclusion criteria: Emergency surgery, newly discovered severe dementia (Red flag: Mini Mental Status Test (MMST) < 15, Montreal Cognitive Assessment (MoCA) < 8) without authorization or legal guardian, 120 km of driving distance to the center, inability to consent due to decreased German language abilities, poor clinical prognosis (survival of less the 15 months).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Delirium prevalence, measured by daily delirium-screening (I-Confusion Assessment Method (I-CAM-S)) over 7 days surgery, as well as after 2 and 6 months, Nursing Delirium Screening Scale (NuDESC) on days 2 and 6 post surgery, and the clinical evaluation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Delirium Duration as described in the prirmary Outcome assessment. Prevalence of POCD 2 and 6 months after surgery as measured by a neuropsychological test battery (Montreal Cognitive Assessment (MoCA), Trail Making Test A and B (TMT A and B) and digit span backwards) as well as cognitive performance measured with the continuous non-standardized test values of these scales. A cognitive deficit is defined as the presence of a test value <= 0.5 standard deviations, normalized for age, gender and education, in one of these test procedures. Persistance of POCD after 12 months. For baseline assessment: sociodemographic assessment, subjective memory impairment (SMI), anamnesis (incl. extended Charlson Comorbidity Index (CCI), the American Society of Anesthesiologists Physical Status classification (ASA), CHA2DS2-score, blood markers, delirium history), grip strength, Whisper and visual acuity test, Timed up and go (TUG), Patient Health Questionnaire 4 items (PHQ-4), EuroQol five dimensions questionnaire (EQ-5D-5L), 12-Item Short Form Survey (SF-12), Mini Nutritional Assessment Short Form (MNA-SF), Barthel Index, CSHA Clinical Frailty Scale, the Visual Analogue Scale (VAS), Pittsburgh Sleep Quality Index PSQI (Basic), STOP-BANG, Sniffin’ sticks 12, Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE), German Zarit Burden Interview (G-ZBI), medication with anticholinergic drugs. For planned analyses: Patient Health Questionnaire 4 items (PHQ-4), EuroQol five dimensions questionnaire (EQ-5D-5L), 12-Item Short Form Survey (SF-12), Mini Nutritional Assessment Short Form (MNA-SF), Barthel Index, CSHA Clinical Frailty Scale, amount and duration of restraints, Nurses’ observation scale for geriatric patients (NOSGER II), Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE), German Zarit Burden Interview (G-ZBI). For planned health-economic analyses: For two centers, hospital costs. For patients insured by AOK Baden-Württemberg: service costs of | — |
Countries
Germany
Contacts
Geriatrisches Zentrum am Universitätsklinikum Tübingen