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

Postoperative Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05847010
• Other study ID #: WB-QC-POD
• Status: Recruiting
• Start date: June 21, 2023
• Est. completion date: December 2024

Study information

• Verified date: June 2023
• Source: Charite University, Berlin, Germany
• Contact: Claudia Spies, MD, Prof.
• Phone: +49 30 450 55 11 02
• Email: claudia.spies[@]charite.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium
• Postoperative Delirium

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Bodytime	Bodytime is determined from monocytes on the morning of surgery.	Before surgery
Secondary	Chronotype 1	"Munich ChronoType Questionnaire" (MCTQ), modified for seniors is measured preoperatively and 3 months postoperatively	Up to three months
Secondary	Chronotype 2	"Morningness-Eveningness-Questionnaire" (D-MEQ) is measured preoperatively and 3 months postoperatively	Up to three months
Secondary	Cholinesterase activity	Cholinesterase activity will be measured by "LISA-CHE" once preoperatively in the morning and in the evening, in the recovery room and on the 1st-3rd postoperative day in the morning and in the afternoon respectively.	Up to the third postoperative day
Secondary	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.
Secondary	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.
Secondary	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
Secondary	Electroencephalography signatures	Electroencephalography signatures are measured during surgery.	During surgery, an expected time of two hours.
Secondary	Sleep monitoring 1	Sleep should be measured with a "Sleep Profiler" that generates electrooculography data.	Up to the third postoperative day
Secondary	Sleep monitoring 2	Sleep should be measured with a "Sleep Profiler" that generates electroencephalography data.	Up to the third postoperative day
Secondary	Sleep monitoring 3	Sleep should be measured with a "Sleep Profiler" that generates electromyogram data.	Up to the third postoperative day
Secondary	Insomnia Severity Index	Patients will assess their sleep quality by Insomnia Severity Index questionnaire.	Up to three months