fall F05 J18 I46 I21 I64 I61 A41 J69 I26
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: • Planned non-emergency surgery (urgency > N2), see Appendix, Table 1 for examples of indications • Expected duration of anesthesia >= 60 min • Patient capable of giving consent or legal guardian or authorized representative with permission in the area of “health care” if the patient is not capable of giving consent.
Exclusion criteria
Exclusion criteria: • Preoperative delirium • Emergency procedures (<N3) • Intracranial procedures • Insufficient knowledge of German
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| new-onset delirium during the first five post-operative days | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of at least one of the following conditions (composite endpoint): • Fall in hospital and up to 30 days after discharge • Serious complication (AE) leading to unplanned intensive care during the hospital stay, e.g. > Cardiac (cardiac arrest, myocardial infarction, new-onset heart failure) > Neurological (stroke or intracerebral hemorrhage) > Pulmonary (aspiration pneumonia, pulmonary artery embolism, new pulmonary infiltrate (HAP), unplanned invasive ventilation > Systemic sepsis • New and ongoing need for nursing care >8 weeks after discharge or change in care level (applied for or approved) • Death within 30 days of discharge Endpoints in follow-up 30 days to 360 days postoperatively • Severe complication (AE) leading to unplanned intensive care in follow-up (FU) • Duration of delirium • Death by end of FU Additional secondary endpoints • Postoperative anemia requiring transfusion | — |
Countries
Germany
Contacts
Klinik für Anästhesiologie, Klinikum der LMU