Postoperative DeliriumNCT02513537
Postoperative Delirium - European Society of Anaesthesiology Survey
An observational study of Postoperative Delirium, run by Charite University, Berlin, Germany at 4 sites in 4 countries.
Trial summary
The ESA is currently preparing a guideline on the management of postoperative delirium (POD), which attempts to reduce the impact of postoperative delirium and provide recommendations for prevention, diagnostics and treatment of delirium outside the intensive care unit. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Delirium
- How many people
- 564 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Aug 2015to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Anaesthesists , nursing statt and students (Members of the European Society of Anaesthesiology)
Who may be able to join
- Anaesthesists, nursing staff, which are invited to the online - Survey of the European Society of Anaesthesiology
Who cannot join
None listed.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Germany1 site
Department of Anaesthesiolgy and Intensive Care Medicine CVK/CCM, Charité - Univeristy Medicine Berlin
Berlin, 13355
Spain1 site
Department of Anaesthesiology, Faculdad de medicina de Valladloid, Hospital Universitario Rio Hortega
Valladolid, 47012
United Kingdom1 site
Department of Anaesthesia, Imperial College NHS Healthcare Trust
London, SW7 2 AZ
About this study
The ESA is currently preparing a guideline on the management of postoperative delirium (POD), which attempts to reduce the impact of postoperative delirium and provide recommendations for prevention, diagnostics and treatment of delirium outside the intensive care unit. The guidelines are going to be published during 2015.
While the guideline provides recommendations for daily practice, assessment of current practice and knowledge is of utmost importance, because the implementation and the measurement of a change in clinical practice will be dependent on these measurements.
This Survey has been approved by the Scientific and Research Committees of the European Society of Anaesthesiology (ESA), the Media Committee of the ESA, as well as the institutional ethical committee of Charité - Universitätsmedizin Berlin.
- 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.
Status of diagnosis of delirium
Answers of ESA-members regarding diagnosis instruments of Delirium. Survey: Multiple Chioce Question. Plus short Essay question to describe prevention (non-structured, non mandatory).
Measured: Up to 6 months
Status of prevention of delirium
Answers of ESA-members regarding prevention measurements of Delirium Survey: Multiple Chioce Question. Plus short Essay question to describe prevention (non-structured, non mandatory).
Measured: Up to 6 months
Status of therapy of delirium
Answers of ESA-members regarding therapy of Delirium. Survey: Multiple Chioce Question. Plus short Essay question to describe prevention (non-structured, non-mandatory).
Measured: Up to 6 months
Secondary outcomes (3)
Status of diagnosis of delirium
Answers of ESA-members regarding diagnosis instruments of Delirium. Survey: Multiple Chioce Question. Plus short Essay question to describe prevention (non-structured, non-mandatory).
Measured: Up to one, two and five years
Status of prevention of delirium
Answers of ESA-members regarding prevention measurements of Delirium. Survey: Multiple Chioce Question. Plus short Essay question to describe prevention (non-structured, non-mandatory).
Measured: Up to one, two and five years
Status of therapy of delirium
Answers of ESA-members regarding therapy of Delirium. Survey: Multiple Chioce Question. Plus short Essay question to describe prevention (non-structured, non-mandatory).
Measured: Up to one, two and five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2020
- Study completionDec 2020
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
- 564 participants (actual)
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, Charité - Univeristy Medicine Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02513537
- Sponsor's protocol ID
- PODESAS
- Status last verified
- Feb 2025
- First submitted
- 20 Mar 2015
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Delirium - European Society of Anaesthesiology Survey
- ClinicalTrials.gov ID
- NCT02513537
- Acronym / sponsor ID
- PODESAS
- Conditions
- Postoperative Delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 564 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 31 Jul 2015 (estimated)
- 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.
The ESA is currently preparing a guideline on the management of postoperative delirium (POD), which attempts to reduce the impact of postoperative delirium and provide recommendations for prevention, diagnostics and treatment of delirium outside the intensive care unit. The guidelines are going to be published during 2015.
While the guideline provides recommendations for daily practice, assessment of current practice and knowledge is of utmost importance, because the implementation and the measurement of a change in clinical practice will be dependent on these measurements.
This Survey has been approved by the Scientific and Research Committees of the European Society of Anaesthesiology (ESA), the Media Committee of the ESA, as well as the institutional ethical committee of Charité - Universitätsmedizin Berlin.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Anaesthesists , nursing statt and students (Members of the European Society of Anaesthesiology)
Key inclusion criteria (1 listed)
- Anaesthesists, nursing staff, which are invited to the online - Survey of the European Society of Anaesthesiology
Key exclusion criteria (0 listed)
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
Status of diagnosis of delirium
Time frame: Up to 6 months
Answers of ESA-members regarding diagnosis instruments of Delirium. Survey: Multiple Chioce Question. Plus short Essay question to describe prevention (non-structured, non mandatory).
Status of prevention of delirium
Time frame: Up to 6 months
Answers of ESA-members regarding prevention measurements of Delirium Survey: Multiple Chioce Question. Plus short Essay question to describe prevention (non-structured, non mandatory).
Status of therapy of delirium
Time frame: Up to 6 months
Answers of ESA-members regarding therapy of Delirium. Survey: Multiple Chioce Question. Plus short Essay question to describe prevention (non-structured, non-mandatory).
3 secondary outcomes
Status of diagnosis of delirium
Time frame: Up to one, two and five years
Status of prevention of delirium
Time frame: Up to one, two and five years
Status of therapy of delirium
Time frame: Up to one, two and five years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
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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. This study is not recruiting at the moment.
Claudia Spies, MD, Prof. study director
Charité - Univeristy Medicine Berlin
4 sites in 4 countries: 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 4 sites in 4 countries.
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 1 inclusion and 0 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: finished, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Italy, Spain, United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Status of diagnosis of delirium (time frame: Up to 6 months). The study lists 3 primary outcomes in all. 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 11 Feb 2025.