Validation of the 3D-CAM to Detect Postoperative Delirium

NCT02992717 | Completed

• 1 other identifier: 3D_CAM
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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).

Conditions

Postoperative Delirium

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Test Quality Level

  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

Study Arms (1)

Patients undergoing elective general anaesthesia

Male and female adult patients undergoing elective general anaesthesia.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male and female adult patients undergoing elective general anaesthesia.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

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

Berlin, 13353, Germany

Location

Related Publications (1)

• 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.

  PMID: 31306183 DERIVED

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Claudia Spies, MD, Prof.

  Charite University, Berlin, Germany

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine Berlin

Study Record Dates

• First Submitted: December 8, 2016
• First Posted: December 14, 2016
• Study Start: January 9, 2017
• Primary Completion: January 4, 2018
• Study Completion: January 5, 2018
• Last Updated: January 18, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)