Validation of the 3D-CAM Turkish Version

Validation of the 3D-CAM Turkish Version in Surgical ICU Patients

Sponsors

Lead Sponsor: Aydin Adnan Menderes University

Source Aydin Adnan Menderes University
Brief Summary

3D CAM into Turkish validity and reliability on postoperative delirium will be test as a prospective diagnostic study. After approval by Dr. Edward R. Marcantonio, (15) will translation and back-translation. The original 3D-CAM will translate into Turkish by two medical doctor .The two translational versions will be discussed and merged into a final version. Back translation will performed in regardless of any information from its original version by another two medical doctor. Both the translated and back translated versions will sent to Dr. Marcantonio for approval. Eligibility and the documentation of consent will be confirmed at the preoperative visit. During this visit, patients will provide demographic and historical medical information, including information regarding medication usage. The Mini-Mental State Exam (MMSE) will be performed. Delirium assessment Delirium assessment with the 3D-CAM Before the study period, all researchers will participate online training program on 3D CAM. Delirium will be evaluated using the 3D CAM every each morning and evening (18:00-20:00) for postoperative 3 days. Delirium assessment with the DSM-5 The psychiatrist investigator who was blinded to the 3D-CAM assessment results, will evaluate the patients according to the criteria of DSM-5 within 3 min after the 3D-CAM assessment.

Overall Status Not yet recruiting
Start Date 2021-04-18
Completion Date 2021-12-18
Primary Completion Date 2021-10-18
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Assessment of delirium 3 days
Enrollment 245
Condition
Intervention

Intervention Type: Diagnostic Test

Intervention Name: 3d cam

Description: The 3D-CAM is a short interview that uses verbal responses and allows completion of the Confusion Assessment Method (CAM) diagnostic algorithm

Arm Group Label: Delirium

Intervention Type: Diagnostic Test

Intervention Name: DSM 5

Description: The DSM-5 is the gold standard for diagnosing delirium. But proper use requires professional psychiatric background and training.

Arm Group Label: Delirium

Eligibility

Criteria:

Inclusion Criteria: - 18 years and older - ASA Physical Status 1-3 - Admitted to the ICU after surgery with a predicted length of stay for more than 48 h - MMSE ≥ 20 (to exclude dementia) Exclusion Criteria: - Refused to participate - Patients with severe visual or auditory disorder/handicaps or endotracheal intubation which might impede communication - Presence of a major psychiatric condition such as bipolar disorder, major depression, schizophrenia, Alzheimer or dementia, Parkinsonism - Deep sedation or coma - ASA physical status IV or V

Gender:

All

Minimum Age:

65 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Contact

Last Name: SINEM S OZTURK

Phone: 4441256

Email: [email protected]

Verification Date

2021-04-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Aydin Adnan Menderes University

Investigator Full Name: SINEM SARI

Investigator Title: Assoc Prof

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Delirium

Type: Other

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Other

Masking: None (Open Label)

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