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

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Delirium

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Claudia Spies, MD, Prof.; Phone Number: +49 30 450 55 11 02; Email: claudia.spies@charite.de

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Recruiting
    • Department of Anaesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum (CVK) and Campus Charite Mitte (CCM), Charite - Universitätsmedizin Berlin
    • Contact: Claudia Spies, MD; Phone Number: +49 30 450 55 11 02; Email: claudia.spies@charite.de
    • Sub-Investigator: Maria Heinrich, MD
    • Principal Investigator: Claudia Spies, MD, Prof.
    • Sub-Investigator: Antje Kirchstein, MD
    • Sub-Investigator: Alexander Ilchmann
    • Sub-Investigator: Florian Lammers, MD
    • Sub-Investigator: Christiaan Nils Richter

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients aged ≥70 years, male and female, who are receiving surgery

Description

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 Plan

How is the study designed?

What is the study measuring?

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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proteomics	Biomarkers of delirium based on proteomics, measured by analysis of a plasma sample.	At the morning of surgery
Metabolomics	Biomarkers of delirium based on metabolomics, measured by analysis of a plasma sample.	At the morning of surgery
Bodytime	Biomarkers of chrono type based on body time, measured by analysis of monocytes.	At the morning of surgery

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Study Director: Claudia Spies, MD, Prof., Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2023
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: April 14, 2023
• First Submitted That Met QC Criteria: April 26, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 22, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Emergence Delirium; Delirium
• Other Study ID Numbers: WB-QC-POD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No