Accompanying Scientific Program for the Quality Contract Prevention of Postoperative Delirium in the Care of Older Patients (WB-QC-POD)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Accompanying Scientific Program for the Quality Contract Prevention of Postoperative Delirium in the Care of Older Patients (WB-QC-POD)

Conditions
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Postoperative Delirium

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 
| Cholinesterase activity | Cholinesterase activity will be measured by LISA-CHE once preoperatively in the morning and in the evening, in the recovery room and on the 1st-3rd postoperative day in the morning and in the afternoon respectively. | Up to the third postoperative day | 
| 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 Tcore™, 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 |