See DRKS (en) (DRKS00013311)
Elective surgery aims to improve the quality of life of people in a cost-effective way. However, the perioperative phase is often a trigger of delirium, due to the burden of the anaesthesia, the pain, the surgical procedure, the activation of the immune system, and other related factors. Delirium is associated with higher morbidity and mortality, cognitive impairment, development of dementia, and a higher institutionalization rate. The probability of delirium after an operation increases with the age of the patient and with the presence of pre-existing cognitive impairment, and is also dependent on the skills of the doctors and caregivers.
Brief Summary
In this study, we investigate whether a transectorial and multimodal intervention for preventing delirium can improve perioperative care of patients older than 70 years subject to an elective surgery intervention by reducing the prevalence of delirium and the postoperative cognitive decline (POCD) within 6 months. Furthermore, we will investigate if the intervention is cost-effective so that the improvement of quality of life does not involve higher costs and the care needs are lower than in the baseline without intervention.
The study takes place at 5 medical centers (with at least 2 surgical departments each) in the south-west of Germany. It follows a stepped wedge design with cluster randomization of the medical centers, and 6 consecutive measurement points: pre-admission, pre- and postoperatively with daily delirium screening up to day 7, 2 and 6 months after surgery, and long-term follow-up after 12 months. The study population consists of 1500 patients older than 70 years going through elective operations (heart, thorax, vessels, proximal big joints and spinal cord, genitourinary, gastrointestinal and general elective surgery procedures). In addition, in an already ongoing sub-study named PAWEL-R (R for Risk), a delirium risk score will be developed and validated with 1800 patients (DRKS00012797).

Scientific Information on the PAWEL Study:

Sánchez, A., Thomas, C., Deeken, F., Wagner, S., Klöppel, S., Kentischer, F., Arnim, C. A. F. von, Denkinger, M., Conzelmann, L. O., Biermann-Stallwitz, J., Joos, S., Sturm, H., Metz, B., Auer, R., Skrobik, Y., Eschweiler, G. W. & Rapp, M. A. (2019). Patient safety, cost-effectiveness, and quality of life: reduction of delirium risk and postoperative cognitive dysfunction after elective procedures in older adults-study protocol for a stepped-wedge cluster randomized trial (PAWEL Study). Trials, 20(1), 71. https://doi.org/10.1186/s13063-018-3148-8


Deeken, F., Sánchez, A., Rapp, M. A., Denkinger, M., Brefka, S., Spank, J., Bruns, C., Arnim, C. A. F. von, Küster, O. C., Conzelmann, L. O., Metz, B. R., Maurer, C., Skrobik, Y., Forkavets, O., Eschweiler, G. W. & Thomas, C. (2021). Outcomes of a Delirium Prevention Program in Older Persons After Elective Surgery: A Stepped-Wedge Cluster Randomized Clinical Trial. JAMA surgery, e216370. https://doi.org/10.1001/jamasurg.2021.6370


Eschweiler, G. W., Czornik, M., Herrmann, M. L., Knauer, Y. P., Forkavets, O., Arnim, C. A. F. von, Denkinger, M., Küster, O., Conzelmann, L., Metz, B. R., Maurer, C., Kentischer, F., Deeken, F., Sánchez, A., Wagner, S., Mennig, E., Thomas, C. & Rapp, M. A. (2021). Presurgical Screening Improves Risk Prediction for Delirium in Elective Surgery of Older Patients: The PAWEL RISK Study. Frontiers in Aging Neuroscience, 13, Artikel 679933, 679933. https://doi.org/10.3389/fnagi.2021.679933



Information on POCD not published yet