Postoperative Delirium
Conditions
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Charite University, Berlin, Germany
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 70 years * Male and female patients * Patients who have been included in QC-POD * Eligible patients\* for inclusion: informed consent by the patient, preoperatively with verbal and written informed consent before the start of data collection * Incapacitated patients for inclusion: Written informed consent by a legal representative * surgery (elective and not elective)
Exclusion criteria
* Moribund patients (palliative situation) * Insufficient knowledge of the German language * Cardiac arrhythmia (e.g. atrial fibrillation) * Presence of a pacemaker * Condition after heart transplantation * Inflammation in the area of the frontal sinus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative Delirium | Up to the fifth postoperative day | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate variability 2 | The participants are followed up until the end of hospital stay, an expected average of 7 days. | Heartrate variability 2 is measured by Bittium Faros 180 until discharge, except during surgery. |
| Sleep monitoring 2 | Up to the third postoperative day | Sleep should be measured with a Sleep Profiler that generates electroencephalography data. |
| Sleep monitoring 3 | Up to the third postoperative day | Sleep should be measured with a Sleep Profiler that generates electromyogram data. |
| Insomnia Severity Index | Up to three months | Patients will assess their sleep quality by Insomnia Severity Index questionnaire. |
| Duration of Delirium | The participants are followed up until the end of hospital stay, an expected average of 7 days | 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. |
| Bodytime | Before surgery | Bodytime is determined from monocytes on the morning of surgery. |
| Chronotype 1 | Up to three months | Munich ChronoType Questionnaire (MCTQ), modified for seniors is measured preoperatively and 3 months postoperatively |
| Chronotype 2 | Up to three months | Morningness-Eveningness-Questionnaire (D-MEQ) is measured preoperatively and 3 months postoperatively |
| Heart rate variability 1 | The participants are followed up until the end of hospital stay, an expected average of 7 days. | 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. |
| Body core temperature | Up to the third postoperative day | Body core temperature is measured with Tcore™, a new non-invasive technology, which employs a unique dual-sensor heat flux technology. |
| Electroencephalography signatures | During surgery, an expected time of two hours. | Electroencephalography signatures are measured during surgery. |
| Sleep monitoring 1 | Up to the third postoperative day | Sleep should be measured with a Sleep Profiler that generates electrooculography data. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Bodytime | At the morning of surgery | Biomarkers of chrono type based on body time, measured by analysis of monocytes. |
| Metabolomics | At the morning of surgery | Biomarkers of delirium based on metabolomics, measured by analysis of a plasma sample. |
| Proteomics | At the morning of surgery | Biomarkers of delirium based on proteomics, measured by analysis of a plasma sample. |
Countries
Germany
Contacts
Primary ContactClaudia Spies, MD, Prof.
Outcome results
None listed