Validation of the 3D-CAM to Detect Postoperative Delirium

NCT ID: NCT02992717

Last Updated: 2018-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-09

Study Completion Date

2018-01-05

Brief Summary

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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

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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

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Postoperative Delirium

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients undergoing elective general anaesthesia

Male and female adult patients undergoing elective general anaesthesia.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
* Patients with unability speaking German or English language
* Participation in other clinical studies during the study period
* Coworker in the study site
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Claudia Spies

Head of the Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine Berlin

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claudia Spies, MD, Prof.

Role: STUDY_DIRECTOR

Charite University, Berlin, Germany

Locations

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Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow - Klinikum, Charite University, Berlin, Germany

Berlin, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 31306183 (View on PubMed)

Other Identifiers

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3D_CAM

Identifier Type: -

Identifier Source: org_study_id

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