Accompanying Scientific Program for the Quality Contract Prevention of Postoperative Delirium in the Care of Older Patients (WB-QC-POD)
Study Details
Study Description
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.
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
- Cholinesterase activity [Up to the third postoperative day]
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.
- 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.
- 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.
- 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.
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 70 years
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Male and female patients
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Patients who have been included in QC-POD
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Eligible patients* for inclusion: informed consent by the patient, preoperatively with verbal and written informed consent before the start of data collection
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Incapacitated patients for inclusion: Written informed consent by a legal representative
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surgery (elective and not elective)
Exclusion Criteria:
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Moribund patients (palliative situation)
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Insufficient knowledge of the German language
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Cardiac arrhythmia (e.g. atrial fibrillation)
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Presence of a pacemaker
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Condition after heart transplantation
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Inflammation in the area of the frontal sinus
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
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| 1 | Department of Anaesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum (CVK) and Campus Charite Mitte (CCM), Charite - Universitätsmedizin Berlin | Berlin | Germany | 13353 |
Sponsors and Collaborators
- Charite University, Berlin, Germany
Investigators
- Study Director: Claudia Spies, MD, Prof., Charite University, Berlin, Germany
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- WB-QC-POD