DeliriumPACUD-EEGNCT03287401
Prediction of PACU Delirium Using EEG - German Validation Study
An observational study of Delirium, run by Technical University of Munich at 1 site in Germany.
Trial summary
Aim of this observational study is to investigate whether frontal electroencephalogram analysis is able to predict increased risk for PACU delirium. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium
- What is being tested?
- Electroencephalography
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 19 Sep 2017to 6 Dec 2019
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All patients above the age of 18 years undergoing general anaesthesia
Who may be able to join
- age: 18 years or older
- surgery in general anaesthesia
Who cannot join
- emergency surgery
- general anaesthesia within 30 days before
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction of Postoperative Anesthesia Care Unit Delirium Using Electroencephalography - German Validation Study
Aim of this observational study is to investigate whether frontal electroencephalogram analysis is able to predict increased risk for PACU delirium.
Read the detailed description
Delirium in the postoperative anaesthesia care unit (PACU), a special of form of postoperative delirium, is associated with increased hospital stay and an elevated hospital re-admission rate. First studies investigating the patients' electroencephalogram (EEG) on emergence from anaesthesia were able to show that an abrupt change of predominant EEG-rhythm is associated with an increased rate of PACU delirium. Therefore, it seems possible to use frontal EEG in order to identify patients being at elevated risk for PACU delirium.
Aim of this observational study is to validate the results of an international collaboration in a German population of patients undergoing general anaesthesia. EEG in these patients is recorded from start of anaesthesia until emergence. Rate of PACU delirium is assessed using the CAM-ICU score 15 and 60 minutes after emergence in the recovery room.
In a pilot study in 626 patients from 2013 to 2015 in 5 international study centres the rate of PACU delirium was 20%. As it is planned to investigate 5 co-factors using regression analysis 50 cases of delirium will be necessary for a sufficient analysis. Therefore, in total 250 patients will be included.
Due to an additional study centre that included 50 patients enrolment of the german validation group was completed after 200 patients.
- Conditions
- Delirium
- Being tested
- Electroencephalography
- Keywords
- EEG, PACU Delirium
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroencephalographyDevice
Patients electroencephalogram will be recorded
| Study group | Role | What they receive |
|---|---|---|
| Patients with general anesthesia | Patients with general anaesthesia are monitored with electroencephalography and the results will be associated with the risk for PACU delirium Receives: Device: Electroencephalography |
What is being measured
The primary outcome is the main question the study is designed to answer.
PACU Delirium
Detection of delirium in the postoperative anaesthesia care unit using CAM-ICU score
Measured: Emergence from anaesthesia until discharge from postoperative anaesthesia care unit (60 minutes)
Secondary outcomes (2)
Pain in the PACU (NRS)
Pain assessed with numeric rating scale
Measured: Emergence from anaesthesia until discharge from postoperative anaesthesia care unit (60 minutes)
Electroencephalography
Electroencephalography recording
Measured: Pre-induction until emergence from anaesthesia (average of 3 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start19 Sep 2017
- Primary completion6 Dec 2019
- Study completion6 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University
- Responsible party
- Sponsor
- Investigators
- Sebastian Schmid, MD, Principal investigator, Klinikum rechts der Isar - Dept. of Anaesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03287401
- Sponsor's protocol ID
- PACUD-EEG
- Acronym
- PACUD-EEG
- Status last verified
- Jan 2020
- First submitted
- 15 Sep 2017
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ely EW, Truman B, Shintani A, Thomason JW, Wheeler AP, Gordon S, Francis J, Speroff T, Gautam S, Margolin R, Sessler CN, Dittus RS, Bernard GR. Monitoring sedation status over time in ICU patients: reliability and validity of the Richmond Agitation-Sedation Scale (RASS). JAMA. 2003 Jun 11;289(22):2983-91. doi: 10.1001/jama.289.22.2983.
PubMed 12799407Lutz R, Muller C, Dragovic S, Schneider F, Ribbe K, Anders M, Schmid S, Garcia PS, Schneider G, Kreuzer M, Kratzer S. The absence of dominant alpha-oscillatory EEG activity during emergence from delta-dominant anesthesia predicts neurocognitive impairment- results from a prospective observational trial. J Clin Anesth. 2022 Nov;82:110949. doi: 10.1016/j.jclinane.2022.110949. Epub 2022 Aug 29.
PubMed 36049381
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Postoperative Anesthesia Care Unit Delirium Using Electroencephalography - German Validation Study
- ClinicalTrials.gov ID
- NCT03287401
- Acronym / sponsor ID
- PACUD-EEG / PACUD-EEG
- Conditions
- Delirium
- Keywords
- EEG, PACU Delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- Emory University
- Study start
- 19 Sep 2017 (actual)
- Primary completion
- 6 Dec 2019 (actual)
- Study completion
- 6 Dec 2019 (actual)
- First posted
- 19 Sep 2017 (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.
Aim of this observational study is to investigate whether frontal electroencephalogram analysis is able to predict increased risk for PACU delirium.
Detailed description
Delirium in the postoperative anaesthesia care unit (PACU), a special of form of postoperative delirium, is associated with increased hospital stay and an elevated hospital re-admission rate. First studies investigating the patients' electroencephalogram (EEG) on emergence from anaesthesia were able to show that an abrupt change of predominant EEG-rhythm is associated with an increased rate of PACU delirium. Therefore, it seems possible to use frontal EEG in order to identify patients being at elevated risk for PACU delirium.
Aim of this observational study is to validate the results of an international collaboration in a German population of patients undergoing general anaesthesia. EEG in these patients is recorded from start of anaesthesia until emergence. Rate of PACU delirium is assessed using the CAM-ICU score 15 and 60 minutes after emergence in the recovery room.
In a pilot study in 626 patients from 2013 to 2015 in 5 international study centres the rate of PACU delirium was 20%. As it is planned to investigate 5 co-factors using regression analysis 50 cases of delirium will be necessary for a sufficient analysis. Therefore, in total 250 patients will be included.
Due to an additional study centre that included 50 patients enrolment of the german validation group was completed after 200 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with general anesthesia | – | Device: ElectroencephalographyPatients with general anaesthesia are monitored with electroencephalography and the results will be associated with the risk for PACU delirium |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients above the age of 18 years undergoing general anaesthesia
Key inclusion criteria (2 listed)
- age: 18 years or older
- surgery in general anaesthesia
Key exclusion criteria (2 listed)
- emergency surgery
- general anaesthesia within 30 days before
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectroencephalographyPatients electroencephalogram will be recorded | Device | Patients with general anesthesia |
Primary outcome
PACU Delirium
Time frame: Emergence from anaesthesia until discharge from postoperative anaesthesia care unit (60 minutes)
Detection of delirium in the postoperative anaesthesia care unit using CAM-ICU score
2 secondary outcomes
Pain in the PACU (NRS)
Time frame: Emergence from anaesthesia until discharge from postoperative anaesthesia care unit (60 minutes)
Electroencephalography
Time frame: Pre-induction until emergence from anaesthesia (average of 3 hours)
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 14 Jan 2020.
- Background: PubMed 12799407Ely EW, Truman B, Shintani A, Thomason JW, Wheeler AP, Gordon S, Francis J, Speroff T, Gautam S, Margolin R, Sessler CN, Dittus RS, Bernard GR. Monitoring sedation status over time in ICU patients: reliability and validity of the Richmond Agitation-Sedation Scale (RASS). JAMA. 2003 Jun 11;289(22):2983-91. doi: 10.1001/jama.289.22.2983.
- Derived from this study: PubMed 36049381Lutz R, Muller C, Dragovic S, Schneider F, Ribbe K, Anders M, Schmid S, Garcia PS, Schneider G, Kreuzer M, Kratzer S. The absence of dominant alpha-oscillatory EEG activity during emergence from delta-dominant anesthesia predicts neurocognitive impairment- results from a prospective observational trial. J Clin Anesth. 2022 Nov;82:110949. doi: 10.1016/j.jclinane.2022.110949. Epub 2022 Aug 29.
- 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. This study is not recruiting at the moment.
Sebastian Schmid, MD principal investigator
Klinikum rechts der Isar - Dept. of Anaesthesiology
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 Delirium, run by Technical University of Munich 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 2 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 14 Jan 2020. 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?
PACU Delirium (time frame: Emergence from anaesthesia until discharge from postoperative anaesthesia care unit (60 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03287401, which also lists 2 linked publications.
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 14 Jan 2020.