Validation of the 3D-CAM to Detect Postoperative Delirium

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

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).

Study Overview

• Status: Completed
• Conditions: Postoperative Delirium

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 Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow - Klinikum, Charite University, Berlin, Germany

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Male and female adult patients undergoing elective general anaesthesia.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients undergoing elective general anaesthesia; Male and female adult patients undergoing elective general anaesthesia.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2017
• Primary Completion (Actual): January 4, 2018
• Study Completion (Actual): January 5, 2018

Study Registration Dates

• First Submitted: December 8, 2016
• First Submitted That Met QC Criteria: December 12, 2016
• First Posted (Estimate): December 14, 2016

Study Record Updates

• Last Update Posted (Actual): January 18, 2018
• Last Update Submitted That Met QC Criteria: January 16, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: 3D_CAM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No