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NCT Number: NCT05847010

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.

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Key information

Conditions

Postoperative Delirium Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Berlin, 13353, Germany

Location status: Recruiting

Location contact

Alexander Ilchmann

SUB_INVESTIGATOR

Antje Kirchstein, MD

SUB_INVESTIGATOR

Christiaan Nils Richter

SUB_INVESTIGATOR

Claudia Spies, MD

CONTACT

[email protected]

+49 30 450 55 11 02

Claudia Spies, MD, Prof.

PRINCIPAL_INVESTIGATOR

Florian Lammers, MD

SUB_INVESTIGATOR

Maria Heinrich, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of postoperative Delirium

    Time frame: 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 outcomes

  1. Duration of Delirium

    Time frame: 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.

  2. Bodytime

    Time frame: Before surgery

    Bodytime is determined from monocytes on the morning of surgery.

  3. Chronotype 1

    Time frame: Up to three months

    "Munich ChronoType Questionnaire" (MCTQ), modified for seniors is measured preoperatively and 3 months postoperatively

  4. Chronotype 2

    Time frame: Up to three months

    "Morningness-Eveningness-Questionnaire" (D-MEQ) is measured preoperatively and 3 months postoperatively

  5. Heart rate variability 1

    Time frame: 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.

  6. Heart rate variability 2

    Time frame: 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.

  7. Body core temperature

    Time frame: 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.

  8. Electroencephalography signatures

    Time frame: During surgery, an expected time of two hours.

    Electroencephalography signatures are measured during surgery.

  9. Sleep monitoring 1

    Time frame: Up to the third postoperative day

    Sleep should be measured with a "Sleep Profiler" that generates electrooculography data.

  10. Sleep monitoring 2

    Time frame: Up to the third postoperative day

    Sleep should be measured with a "Sleep Profiler" that generates electroencephalography data.

  11. Sleep monitoring 3

    Time frame: Up to the third postoperative day

    Sleep should be measured with a "Sleep Profiler" that generates electromyogram data.

  12. Insomnia Severity Index

    Time frame: Up to three months

    Patients will assess their sleep quality by Insomnia Severity Index questionnaire.

Other outcomes

  1. Proteomics

    Time frame: At the morning of surgery

    Biomarkers of delirium based on proteomics, measured by analysis of a plasma sample.

  2. Metabolomics

    Time frame: At the morning of surgery

    Biomarkers of delirium based on metabolomics, measured by analysis of a plasma sample.

  3. Bodytime

    Time frame: At the morning of surgery

    Biomarkers of chrono type based on body time, measured by analysis of monocytes.

Study contacts

Contact information is provided by the study sponsor or research team.

Claudia Spies, MD, Prof.

CONTACT

[email protected]

+49 30 450 55 11 02

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 6, 2023
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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