Validation of the 3D-CAM Turkish Version

Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04853706
• Other study ID #: 2021/28
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 18, 2021
• Est. completion date: December 18, 2021

Study information

• Verified date: April 2021
• Source: Aydin Adnan Menderes University
• Contact: SINEM S OZTURK
• Phone: 4441256
• Email: sarisinem[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 245
• Est. completion date: December 18, 2021
• Est. primary completion date: October 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Validity

Intervention

Diagnostic Test:
• 3d cam
The 3D-CAM is a short interview that uses verbal responses and allows completion of the Confusion Assessment Method (CAM) diagnostic algorithm
• DSM 5
The DSM-5 is the gold standard for diagnosing delirium. But proper use requires professional psychiatric background and training.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aydin Adnan Menderes University

References & Publications (1)

Mu DL, Ding PP, Zhou SZ, Liu MJ, Sun XY, Li XY, Wang DX. Cross-cultural adaptation and validation of the 3D-CAM Chinese version in surgical ICU patients. BMC Psychiatry. 2020 Mar 24;20(1):133. doi: 10.1186/s12888-020-02544-w. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of delirium	Delirium will be evaluated using the 3D CAM every each morning and evening (18:00-20:00) for postoperative 3 days. The psychiatrist investigator who will be 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.	3 days