Clinical trial NCT05847010: Accompanying Scientific Program for the Quality Contract Prevention of Postoperative Delirium in the Care of Older Patients (WB-QC-POD)
Official title: Accompanying Scientific Program for the Quality Contract Prevention of Postoperative Delirium in the Care of Older Patients (WB-QC-POD)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Postoperative Delirium
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 100
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged ≥70 years, male and female, who are receiving surgery

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.

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

Primary outcomes:
measure: Incidence of postoperative Delirium
timeFrame: Up to the fifth postoperative day
Secondary outcomes:
measure: Duration of Delirium
timeFrame: The participants are followed up until the end of hospital stay, an expected average of 7 days
measure: Bodytime
timeFrame: Before surgery
measure: Chronotype 1
timeFrame: Up to three months
measure: Chronotype 2
timeFrame: Up to three months
measure: Heart rate variability 1
timeFrame: The participants are followed up until the end of hospital stay, an expected average of 7 days.
measure: Heart rate variability 2
timeFrame: The participants are followed up until the end of hospital stay, an expected average of 7 days.
measure: Body core temperature
timeFrame: Up to the third postoperative day
measure: Electroencephalography signatures
timeFrame: During surgery, an expected time of two hours.
measure: Sleep monitoring 1
timeFrame: Up to the third postoperative day
measure: Sleep monitoring 2
timeFrame: Up to the third postoperative day
measure: Sleep monitoring 3
timeFrame: Up to the third postoperative day
measure: Insomnia Severity Index
timeFrame: Up to three months
Other outcomes:
measure: Proteomics
timeFrame: At the morning of surgery
measure: Metabolomics
timeFrame: At the morning of surgery
measure: Bodytime
timeFrame: At the morning of surgery
Locations:
city: Berlin
country: Germany
facility: Department of Anaesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum (CVK) and Campus Charite Mitte (CCM), Charite - Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia Spies, MD, Prof.
role: STUDY_DIRECTOR
References: