Validation of the 3D-CAM to Detect Postoperative Delirium

Study Overview
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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.

Official Title
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Validation of the 3D-CAM in the Recovery Room to Detect Postoperative Delirium Compared to Nu-DESC, CAM and DSM-5 Criteria

Conditions
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Postoperative Delirium

Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing elective general anaesthesia<br>Male and female adult patients undergoing elective general anaesthesia. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Up to three days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test Quality Level | Comparison of test Quality level between 3D-CAM, Nu-DESC and CAM to detect POD in the recovery room. | Up to three days | 
| Duration of postoperative delirium |  | Up to three days | 
| Duration of stay in recovery room |  | Up to three days | 
| Duration of performance of the delirium testings |  | Up to three days | 
| Pain level |  | Participants will be followed up until the third postoperative day | 
| Postoperative complications | Postoperative complications according to Clavien-Dindo classification | Up to three days | 
| Duration of hospital stay |  | Participants will be followed for the duration of hospital stay an expected average of 3 weeks | 
| In-house mortality |  | Participants will be followed for the duration of hospital stay an expected average of 3 weeks | 
| Follow-up care |  | Participants will be followed for the duration of hospital stay an expected average of 3 weeks |