Validation of the 3D-CAM Turkish Version in Surgical ICU Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 245
- 主要终点
- Assessment of delirium
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Assessment of delirium
时间窗: 3 days
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.
次要结局
未报告次要终点
研究者
SINEM SARI
Assoc Prof
Aydin Adnan Menderes University