Postoperative DeliriumNCT05847010
Accompanying Scientific Program for the Quality Contract Prevention of Postoperative Delirium in the Care of Older Patients (WB-QC-POD)
An observational study of Postoperative Delirium, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Postoperative Delirium
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 22 Jun 2023to Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients aged ≥70 years, male and female, who are receiving surgery
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Anaesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum (CVK) and Campus Charite Mitte (CCM), Charite - Universitätsmedizin Berlin
Berlin, 13353
Claudia Spies, MD, +49 30 450 55 11 02, claudia.spies@charite.de
Claudia Spies, MD, Prof.
About this study
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.
Read the 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
- Medical subject headings
- Emergence Delirium
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to the fifth postoperative day
Secondary outcomes (12)
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.
Measured: 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.
Measured: Before surgery
Chronotype 1
"Munich ChronoType Questionnaire" (MCTQ), modified for seniors is measured preoperatively and 3 months postoperatively
Measured: Up to three months
Chronotype 2
"Morningness-Eveningness-Questionnaire" (D-MEQ) is measured preoperatively and 3 months postoperatively
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to the third postoperative day
Electroencephalography signatures
Electroencephalography signatures are measured during surgery.
Measured: During surgery, an expected time of two hours.
Sleep monitoring 1
Sleep should be measured with a "Sleep Profiler" that generates electrooculography data.
Measured: Up to the third postoperative day
Sleep monitoring 2
Sleep should be measured with a "Sleep Profiler" that generates electroencephalography data.
Measured: Up to the third postoperative day
Sleep monitoring 3
Sleep should be measured with a "Sleep Profiler" that generates electromyogram data.
Measured: Up to the third postoperative day
Insomnia Severity Index
Patients will assess their sleep quality by Insomnia Severity Index questionnaire.
Measured: Up to three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start22 Jun 2023
- Primary completionJul 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, MD, Prof., Study director, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847010
- Sponsor's protocol ID
- WB-QC-POD
- Status last verified
- Jan 2025
- First submitted
- 14 Apr 2023
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accompanying Scientific Program for the Quality Contract Prevention of Postoperative Delirium in the Care of Older Patients (WB-QC-POD)
- ClinicalTrials.gov ID
- NCT05847010
- Acronym / sponsor ID
- WB-QC-POD
- Conditions
- Postoperative Delirium
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 22 Jun 2023 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients aged ≥70 years, male and female, who are receiving surgery
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- Moribund patients (palliative situation)
- Insufficient knowledge of the German language
- Cardiac arrhythmia (e.g. atrial fibrillation)
- Presence of a pacemaker
- Condition after heart transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
12 secondary outcomes
Duration of Delirium
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days
Bodytime
Time frame: Before surgery
Chronotype 1
Time frame: Up to three months
Chronotype 2
Time frame: Up to three months
Heart rate variability 1
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days.
Heart rate variability 2
Time frame: The participants are followed up until the end of hospital stay, an expected average of 7 days.
Body core temperature
Time frame: Up to the third postoperative day
Electroencephalography signatures
Time frame: During surgery, an expected time of two hours.
Sleep monitoring 1
Time frame: Up to the third postoperative day
Sleep monitoring 2
Time frame: Up to the third postoperative day
Sleep monitoring 3
Time frame: Up to the third postoperative day
Insomnia Severity Index
Time frame: Up to three months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Claudia Spies, MD, Prof. study director
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Delirium, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claudia Spies, MD, Prof. (+49 30 450 55 11 02, claudia.spies@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative Delirium (time frame: Up to the fifth postoperative day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.