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In the course of a scientific accompanying program, the project pursues the goal of gaining further insight into a possible connection between various influencing factors and the development of postoperative delirium. Against this background, in addition to the primary goal of exploring delirium rates, we aim to identify associations between other secondary end goals like the internal circadian time or the heart rate variability and the occurrence of postoperative delirium. For this purpose, patients of the QC-POD (NCT04355195) sample will be studied.
The project aims to improve the understanding of the internal circadian time (chronotype) and other sleep parameters, as well as further secondary end goals, in relation to the development of postoperative delirium. In the course of this the project would like to investigate the perioperative heart rate variability. Also, the association of perioperative peripheral cholinesterase activity with perioperative heart rate variability and the development of POD will be explored. Additionally, the investigator will analyze the correlation of intraoperative EEG signatures with perioperative heart rate variability, and explore any association of core body temperature and the development of postoperative Delirium.
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postoperative Delirium | Incidence of postoperative delirium in all postoperative patients in normal ward, intensive care unit and recovery room with a validated delirium screening tool at two points in time. | Up to the fifth postoperative day |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Delirium | Duration (in days) of postoperative delirium in all postoperative patients in normal ward, intensive care unit and recovery room with a validated delirium screening tool at two points in time. | The participants are followed up until the end of hospital stay, an expected average of 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Proteomics | Biomarkers of delirium based on proteomics, measured by analysis of a plasma sample. | At the morning of surgery |
| Metabolomics | Biomarkers of delirium based on metabolomics, measured by analysis of a plasma sample. |
Inclusion Criteria:
Exclusion Criteria:
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Patients aged ≥70 years, male and female, who are receiving surgery
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claudia Spies, MD, Prof. | Contact | +49 30 450 55 11 02 | claudia.spies@charite.de |
| Name | Affiliation | Role |
|---|---|---|
| Claudia Spies, MD, Prof. | Charite University, Berlin, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anaesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum (CVK) and Campus Charite Mitte (CCM), Charite - Universitätsmedizin Berlin | Recruiting | Berlin | 13353 | Germany |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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Blood samples (monocytes and Cholinesterase activity)
| Bodytime |
Bodytime is determined from monocytes on the morning of surgery. |
| Before surgery |
| Chronotype 1 | "Munich ChronoType Questionnaire" (MCTQ), modified for seniors is measured preoperatively and 3 months postoperatively | Up to three months |
| Chronotype 2 | "Morningness-Eveningness-Questionnaire" (D-MEQ) is measured preoperatively and 3 months postoperatively | Up to three months |
| Heart rate variability 1 | Heartrate variability 1 is measured by "ANI Monitor V2" until discharge. With the "Ani Monitor V2", heart rate variability is recorded twice a day and intraoperatively. | The participants are followed up until the end of hospital stay, an expected average of 7 days. |
| Heart rate variability 2 | Heartrate variability 2 is measured by "Bittium Faros 180" until discharge, except during surgery. | The participants are followed up until the end of hospital stay, an expected average of 7 days. |
| Body core temperature | Body core temperature is measured with "Tcoreâ„¢", a new non-invasive technology, which employs a unique dual-sensor heat flux technology. | Up to the third postoperative day |
| Electroencephalography signatures | Electroencephalography signatures are measured during surgery. | During surgery, an expected time of two hours. |
| Sleep monitoring 1 | Sleep should be measured with a "Sleep Profiler" that generates electrooculography data. | Up to the third postoperative day |
| Sleep monitoring 2 | Sleep should be measured with a "Sleep Profiler" that generates electroencephalography data. | Up to the third postoperative day |
| Sleep monitoring 3 | Sleep should be measured with a "Sleep Profiler" that generates electromyogram data. | Up to the third postoperative day |
| Insomnia Severity Index | Patients will assess their sleep quality by Insomnia Severity Index questionnaire. | Up to three months |
| At the morning of surgery |
| Bodytime | Biomarkers of chrono type based on body time, measured by analysis of monocytes. | At the morning of surgery |
|
| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |