Accompanying Scientific Program for the Quality Contract Prevention of Postoperative Delirium in the Care of Older Patients (WB-QC-POD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Postoperative Delirium. Basic parameters: from 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Incidence of postoperative Delirium [Time frame: Up to the fifth postoperative day]
Secondary outcome measures (12)
- Duration of Delirium [Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days]
- Bodytime [Time frame: Before surgery]
- Chronotype 1 [Time frame: Up to three months]
- Chronotype 2 [Time frame: Up to three months]
- Heart rate variability 1 [Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days.]
- Heart rate variability 2 [Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days.]
- Body core temperature [Time frame: Up to the third postoperative day]
- Electroencephalography signatures [Time frame: During surgery, an expected time of two hours.]
- Sleep monitoring 1 [Time frame: Up to the third postoperative day]
- Sleep monitoring 2 [Time frame: Up to the third postoperative day]
- Sleep monitoring 3 [Time frame: Up to the third postoperative day]
- Insomnia Severity Index [Time frame: Up to three months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Department of Anaesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum (CVK) a — Berlin
Identifiers
NCT: NCT05847010 · WB-QC-POD