Validation of the 3D-CAM to Detect Postoperative Delirium

Charite University, Berlin, Germany200 enrolled

Overview

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).

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 Type

OBSERVATIONAL

Enrollment

200

Conditions

Postoperative Delirium

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

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

Berlin, Germany

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: Up to three days

Secondary Outcomes

Test Quality Level

Comparison of test Quality level between 3D-CAM, Nu-DESC and CAM to detect POD in the recovery room.

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

Postoperative complications according to Clavien-Dindo classification

Time frame: Up to three days

Data from ClinicalTrials.gov

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