Postoperative DeliriumNCT02992717
Validation of the 3D-CAM to Detect Postoperative Delirium
An observational study of Postoperative Delirium, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The 3D-CAM is a new 3-minute diagnostic assessment for Confusion Assessment Method-defined Delirium. The primary objective of this study is to translate the 3D-CAM into the German language, as well as to validate its use to detect postoperative delirium in the recovery room. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Delirium
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 9 Jan 2017to 5 Jan 2018
- 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: Male and female adult patients undergoing elective general anaesthesia.
Who may be able to join
- Male and female patients with age ≥ 18 years
- Admission to recovery room (RR) or post anaesthesia care unit (PACU) following elective general anaesthesia and scheduled
- Inpatient treatment not less than 24 hours.
Who cannot join
- Patients with psychiatric diseases and mental retardation
- Analphabetism
- Anacusis or Hypoacusis with hearing aid device,
- Amaurosis
- Lacking willingness to save and hand out data within the study
- Accommodation in an institution due to an official or judicial order
Show all 9Show fewer
- Patients with unability speaking German or English language
- Participation in other clinical studies during the study period
- Coworker in the study site
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow - Klinikum, Charite University, Berlin, Germany
Berlin, 13353
About this study
Official title: Validation of the 3D-CAM in the Recovery Room to Detect Postoperative Delirium Compared to Nu-DESC, CAM and DSM-5 Criteria
The 3D-CAM is a new 3-minute diagnostic assessment for Confusion Assessment Method-defined Delirium. The primary objective of this study is to translate the 3D-CAM into the German language, as well as to validate its use to detect postoperative delirium in the recovery room. The validation will be based on comparisons to the Nu-DESC (Nursing Delirium Screening Scale), CAM (Confusion Assessment Method), and DSM-5 criteria (Diagnostic and Statistical Manual of Mental Disorders).
Read the detailed description
Approximately 200 patients will be enrolled in the study. They will followed up until the third postoperative day.
Calculation and analysis of demographic and perioperative influencing factors on postoperative delirium according to routine parameters (age, sex, body height, body weight, diagnosis, physical status according to the American Society of Anaesthesiologists (ASA PS), duration of surgery, Physiological and Operative Severity Score (POSSUM), type of anesthesia, medication against pain and delirium) will be performed.
- Conditions
- Postoperative Delirium
- Medical subject headings
- Emergence 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 |
|---|---|---|
| Patients undergoing elective general anaesthesia | Male and female adult patients undergoing elective general anaesthesia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the delirium screening/diagnosing tool "3D Confusion Assessment Method (3D-CAM)
Sensitivity of the delirium screening/diagnosing tool "3D Confusion Assessment Method (3D-CAM)" to detect postoperative delirium (POD) in the recovery room - Used reference standard: DSM-5 criteria
Measured: Up to three days
Specificity of the delirium screening/diagnosing tool "3D Confusion Assessment Method (3D-CAM)
Specificity of the delirium screening/diagnosing tool "3D Confusion Assessment Method (3D-CAM) to detect postoperative delirium (POD) in the recovery room - Used reference standard: DSM-5 criteria
Measured: Up to three days
Secondary outcomes (9)
Test Quality Level
Comparison of test Quality level between 3D-CAM, Nu-DESC and CAM to detect POD in the recovery room.
Measured: Up to three days
Duration of postoperative delirium
Measured: Up to three days
Duration of stay in recovery room
Measured: Up to three days
Duration of performance of the delirium testings
Measured: Up to three days
Pain level
Measured: Participants will be followed up until the third postoperative day
Postoperative complications
Postoperative complications according to Clavien-Dindo classification
Measured: Up to three days
Duration of hospital stay
Measured: Participants will be followed for the duration of hospital stay an expected average of 3 weeks
In-house mortality
Measured: Participants will be followed for the duration of hospital stay an expected average of 3 weeks
Follow-up care
Measured: Participants will be followed for the duration of hospital stay an expected average of 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study start9 Jan 2017
- Primary completion4 Jan 2018
- Study completion5 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 200 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, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02992717
- Sponsor's protocol ID
- 3D_CAM
- Status last verified
- Jan 2018
- First submitted
- 8 Dec 2016
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Olbert M, Eckert S, Morgeli R, Kruppa J, Spies CD. Validation of 3-minute diagnostic interview for CAM-defined Delirium to detect postoperative delirium in the recovery room: A prospective diagnostic study. Eur J Anaesthesiol. 2019 Sep;36(9):683-687. doi: 10.1097/EJA.0000000000001048.
PubMed 31306183
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the 3D-CAM in the Recovery Room to Detect Postoperative Delirium Compared to Nu-DESC, CAM and DSM-5 Criteria
- ClinicalTrials.gov ID
- NCT02992717
- Acronym / sponsor ID
- 3D_CAM
- Conditions
- Postoperative Delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 9 Jan 2017 (actual)
- Primary completion
- 4 Jan 2018 (actual)
- Study completion
- 5 Jan 2018 (actual)
- First posted
- 14 Dec 2016 (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 3D-CAM is a new 3-minute diagnostic assessment for Confusion Assessment Method-defined Delirium. The primary objective of this study is to translate the 3D-CAM into the German language, as well as to validate its use to detect postoperative delirium in the recovery room. The validation will be based on comparisons to the Nu-DESC (Nursing Delirium Screening Scale), CAM (Confusion Assessment Method), and DSM-5 criteria (Diagnostic and Statistical Manual of Mental Disorders).
Detailed description
Approximately 200 patients will be enrolled in the study. They will followed up until the third postoperative day.
Calculation and analysis of demographic and perioperative influencing factors on postoperative delirium according to routine parameters (age, sex, body height, body weight, diagnosis, physical status according to the American Society of Anaesthesiologists (ASA PS), duration of surgery, Physiological and Operative Severity Score (POSSUM), type of anesthesia, medication against pain and delirium) will be performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing elective general anaesthesia | – | –Male and female adult patients undergoing elective general anaesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female adult patients undergoing elective general anaesthesia.
Key inclusion criteria (3 listed)
- Male and female patients with age ≥ 18 years
- Admission to recovery room (RR) or post anaesthesia care unit (PACU) following elective general anaesthesia and scheduled
- Inpatient treatment not less than 24 hours.
Key exclusion criteria (9 listed)
- Patients with psychiatric diseases and mental retardation
- Analphabetism
- Anacusis or Hypoacusis with hearing aid device,
- Amaurosis
- Lacking willingness to save and hand out data within the study
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
Sensitivity of the delirium screening/diagnosing tool "3D Confusion Assessment Method (3D-CAM)
Time frame: Up to three days
Sensitivity of the delirium screening/diagnosing tool "3D Confusion Assessment Method (3D-CAM)" to detect postoperative delirium (POD) in the recovery room - Used reference standard: DSM-5 criteria
Specificity of the delirium screening/diagnosing tool "3D Confusion Assessment Method (3D-CAM)
Time frame: Up to three days
Specificity of the delirium screening/diagnosing tool "3D Confusion Assessment Method (3D-CAM) to detect postoperative delirium (POD) in the recovery room - Used reference standard: DSM-5 criteria
9 secondary outcomes
Test Quality Level
Time frame: Up to three days
Duration of postoperative delirium
Time frame: Up to three days
Duration of stay in recovery room
Time frame: Up to three days
Duration of performance of the delirium testings
Time frame: Up to three days
Pain level
Time frame: Participants will be followed up until the third postoperative day
Postoperative complications
Time frame: Up to three days
Duration of hospital stay
Time frame: Participants will be followed for the duration of hospital stay an expected average of 3 weeks
In-house mortality
Time frame: Participants will be followed for the duration of hospital stay an expected average of 3 weeks
Follow-up care
Time frame: Participants will be followed for the duration of hospital stay an expected average of 3 weeks
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 18 Jan 2018.
- Derived from this study: PubMed 31306183Olbert M, Eckert S, Morgeli R, Kruppa J, Spies CD. Validation of 3-minute diagnostic interview for CAM-defined Delirium to detect postoperative delirium in the recovery room: A prospective diagnostic study. Eur J Anaesthesiol. 2019 Sep;36(9):683-687. doi: 10.1097/EJA.0000000000001048.
- 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.
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 3 inclusion and 9 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 18 Jan 2018. 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?
Sensitivity of the delirium screening/diagnosing tool "3D Confusion Assessment Method (3D-CAM) (time frame: Up to three days). 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?
On the ClinicalTrials.gov record for NCT02992717, which also lists 1 linked publication.
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 18 Jan 2018.