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

Recruiting

• Conditions: Postoperative Delirium

• Registration Number: NCT05847010
• Lead Sponsor: Charite University, Berlin, Germany

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.

Study Timeline

• Study First Submitted: 2023-04-14
• Study First Submitted QC: 2023-04-26
• Study First Posted: 2023-05-06
• Study Start: 2023-06-22
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-22
• Last Update Posted: 2025-01-23
• Primary Completion: 2025-07
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Department of Anaesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum (CVK) and Campus Charite Mitte (CCM), Charite - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany