Data privacy
Personal data of patients are collected only to the extent required by the study protocol. All data collected through observation of the intervention will be collected in a pseudonymized manner. Only excerpts from the anaesthesia protocol for documentation of vital signs during the intervention will be directly assignable to individual patients and will be processed and stored in accordance with the applicable national and EU data protection regulations and the principles of Good Clinical Practice. Data of the care providers will be collected anonymously. Detailed information for participants on collecting, processing, and storing trial data will be part of the patients’ information brochure.