Validation of the 3D-CAM to Detect Postoperative Delirium

Completed

• Conditions: Postoperative Delirium

• Registration Number: NCT02992717
• Lead Sponsor: Charite University, Berlin, Germany

Brief 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. 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 Timeline

• Study First Submitted: 2016-12-08
• Study First Submitted QC: 2016-12-12
• Study First Posted: 2016-12-14
• Study Start: 2017-01-09
• Status Verified: 2018-01
• Primary Completion: 2018-01-04
• Study Completion: 2018-01-05
• Last Update Submitted: 2018-01-16
• Last Update Posted: 2018-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Specificity of the delirium screening/diagnosing tool "3D Confusion Assessment Method (3D-CAM)	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
Sensitivity of the delirium screening/diagnosing tool "3D Confusion Assessment Method (3D-CAM)	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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