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

NCT ID: NCT05847010

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-22
• Study Completion Date: 2025-09-30

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.

Conditions

Postoperative Delirium

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Claudia Spies

Head of the Department of Anesthesiolgy and Intensive Care Medicine CC07

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claudia Spies, MD, Prof.

Role: STUDY_DIRECTOR

Charite University, Berlin, Germany

Locations

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

Berlin, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Claudia Spies, MD, Prof.

Role: CONTACT

claudia.spies@charite.de

+49 30 450 55 11 02

Facility Contacts

Claudia Spies, MD

Role: primary

claudia.spies@charite.de

+49 30 450 55 11 02

Other Identifiers

WB-QC-POD

Identifier Type: -

Identifier Source: org_study_id