Postoperative DeliriumPADE-DICNCT04978870
Diagnosis, Incidence and Consequences of PACU-Delirium
An observational study of Postoperative Delirium and Elderly Patient, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
This study aims to 1. determine sensitivity and specificity of the Confusion Assessment Method for Postanesthesia Care Unit (CAM-PACU) 2. examine the effect of postanesthesia care unit delirium (PACU delirium) on the emergence of later onset postoperative delirium (POD) as well as cognitive recovery until one month… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Delirium, Elderly Patient, Cognitive Decline
- How many people
- 450 participants
- Where
- 1 siteGermany
- Study dates
- 29 Jul 2021to 1 Aug 2024
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients meeting inclusion criteria and presenting for sheduled surgery at the University Medical Centre Hamburg, Germany.
Who may be able to join
- planned surgery in the near future
- surgery time at least 60min
Who cannot join
- intracranial surgery
- expected postoperative transfer to ICU and stay exceeding 24h
- length of postoperative stay in hospital below 24h
- insufficient German language skills
- current alcohol or drug misuse
- manifest mental illness
Trial locations and contacts
1 site in 1 country.
Germany1 site
Hamburg University Medical Centre Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20251
About this study
Official title: Diagnosis, Incidence and Consequences of Postoperative Delirium in Elderly Patients in the Post-anaesthetic Care Unit
This study aims to
- determine sensitivity and specificity of the Confusion Assessment Method for Postanesthesia Care Unit (CAM-PACU)
- examine the effect of postanesthesia care unit delirium (PACU delirium) on the emergence of later onset postoperative delirium (POD) as well as cognitive recovery until one month postoperatively
- Conditions
- Postoperative Delirium, Elderly Patient, Cognitive Decline
- Keywords
- Post-anesthetic care, Cognitive recovery, Delirium
- Medical subject headings
- Emergence Delirium, Cognitive Dysfunction, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 - Validation | Group 1 will be screened for delirium during the PACU stay using the CAM-PACU. Delirium criteria as defined by ICD-10 will be assessed in comparison. A subgroup of patients will receive an additional delirium screening using the CAM-PACU. This screening will be performed by another operator blinded for the results from the initial delirium screening. | |
| 2 - Cognition | Group 2 will be screened for delirium during the PACU stay using the CAM-PACU. Delirium criteria as defined by ICD-10 will be assessed in comparison. This group will undergo additional assessment of preoperative and postoperative cognitive function as well as a POD screening using the 3D-CAM starting at postoperative day 1 until discharge from hospital but no longer than postoperative day 5. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Group 1: Sensitivity and specificity of "Confusion Assessment Method - Postanesthetic Care Unit" (CAM-PACU)
in reference to International Classification of Diseases-Version 10 (ICD-10)
Measured: 15-240 minutes postoperatively
Group 2: postoperative delirium after discharge from Postanesthetic Care Unit
3D CAM and/or medical record
Measured: 0-5 days postoperatively
Secondary outcomes (4)
re-test reliability
CAM-PACU
Measured: 15-240 minutes postoperatively
cognitive performance
Montreal Cognitive Assessment (MoCA, 0-30 points, higher score = better outcome), Cognitive Telephone Screening Instrument (COGTEL), Patient Reported Outcomes Measurement Information System (PROMIS Neuro QoL)
Measured: before, 7 and 30 days postoperatively
postoperative complications
European Perioperative Clinical Outcome (EPCO) definitions; Standardised Endpoints in Perioperative Medicine - Core Outcome Measures in Perioperative and Anaesthetic Care (Step-COMPAC) definitions
Measured: 30 days postoperatively
feasibility of delirium screening by questioning of medical staff
self-designed questionnaire
Measured: before, 3 and 12 months after implementation of CAM-PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start29 Jul 2021
- Primary completion30 Sep 2023
- Study completion1 Aug 2024
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 Universitätsklinikum Hamburg-EppendorfThe 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
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04978870
- Sponsor's protocol ID
- 2020-10331-BO-ff
- Acronym
- PADE-DIC
- Status last verified
- Feb 2025
- First submitted
- 25 Jun 2021
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis, Incidence and Consequences of Postoperative Delirium in Elderly Patients in the Post-anaesthetic Care Unit
- ClinicalTrials.gov ID
- NCT04978870
- Acronym / sponsor ID
- PADE-DIC / 2020-10331-BO-ff
- Conditions
- Postoperative Delirium, Elderly Patient, Cognitive Decline
- Keywords
- Post-anesthetic care, Cognitive recovery, Delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 29 Jul 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 27 Jul 2021 (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.
This study aims to
- determine sensitivity and specificity of the Confusion Assessment Method for Postanesthesia Care Unit (CAM-PACU)
- examine the effect of postanesthesia care unit delirium (PACU delirium) on the emergence of later onset postoperative delirium (POD) as well as cognitive recovery until one month postoperatively
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 - Validation | – | –Group 1 will be screened for delirium during the PACU stay using the CAM-PACU. Delirium criteria as defined by ICD-10 will be assessed in comparison. A subgroup of patients will receive an additional delirium screening using the CAM-PACU. This screening will be performed by another operator blinded for the results from the initial delirium screening. |
| 2 - Cognition | – | –Group 2 will be screened for delirium during the PACU stay using the CAM-PACU. Delirium criteria as defined by ICD-10 will be assessed in comparison. This group will undergo additional assessment of preoperative and postoperative cognitive function as well as a POD screening using the 3D-CAM starting at postoperative day 1 until discharge from hospital but no longer than postoperative day 5. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients meeting inclusion criteria and presenting for sheduled surgery at the University Medical Centre Hamburg, Germany.
Key inclusion criteria (2 listed)
- planned surgery in the near future
- surgery time at least 60min
Key exclusion criteria (6 listed)
- intracranial surgery
- expected postoperative transfer to ICU and stay exceeding 24h
- length of postoperative stay in hospital below 24h
- insufficient German language skills
- current alcohol or drug misuse
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
Group 1: Sensitivity and specificity of "Confusion Assessment Method - Postanesthetic Care Unit" (CAM-PACU)
Time frame: 15-240 minutes postoperatively
in reference to International Classification of Diseases-Version 10 (ICD-10)
Group 2: postoperative delirium after discharge from Postanesthetic Care Unit
Time frame: 0-5 days postoperatively
3D CAM and/or medical record
4 secondary outcomes
re-test reliability
Time frame: 15-240 minutes postoperatively
cognitive performance
Time frame: before, 7 and 30 days postoperatively
postoperative complications
Time frame: 30 days postoperatively
feasibility of delirium screening by questioning of medical staff
Time frame: before, 3 and 12 months after implementation of CAM-PACU
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 21 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Elderly Patient, run by Universitätsklinikum Hamburg-Eppendorf 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 2 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: finished, as of the sponsor's last update on 21 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 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?
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?
Group 1: Sensitivity and specificity of "Confusion Assessment Method - Postanesthetic Care Unit" (CAM-PACU) (time frame: 15-240 minutes postoperatively). The study lists 2 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 21 Feb 2025.