Validation of the 3D-CAM to Detect Postoperative Delirium

Postoperative Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02992717
• Other study ID #: 3D_CAM
• Status: Completed
• Phase: N/A
• First received: December 8, 2016
• Last updated: January 16, 2018
• Start date: January 9, 2017
• Est. completion date: January 5, 2018

Study information

• Verified date: January 2018
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 5, 2018
• Est. primary completion date: January 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Postoperative Delirium

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Duration of postoperative delirium		Up to three days
Secondary	Duration of stay in recovery room		Up to three days
Secondary	Duration of performance of the delirium testings		Up to three days
Secondary	Pain level		Participants will be followed up until the third postoperative day
Secondary	Postoperative complications	Postoperative complications according to Clavien-Dindo classification	Up to three days
Secondary	Duration of hospital stay		Participants will be followed for the duration of hospital stay an expected average of 3 weeks
Secondary	In-house mortality		Participants will be followed for the duration of hospital stay an expected average of 3 weeks
Secondary	Follow-up care		Participants will be followed for the duration of hospital stay an expected average of 3 weeks