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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04853706
Other study ID # 2021/28
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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