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验证中文版3D-CAM的敏感性和特异性
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注册号:

Registration number:

ChiCTR-OOC-17011887 

最近更新日期:

Date of Last Refreshed on:

2020-03-15 

注册时间:

Date of Registration:

2017-07-06 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

验证中文版3D-CAM的敏感性和特异性 

Public title:

Validation of the sensitivity and specialty of Chinese version 3D-CAM 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

验证中文版3D-CAM的敏感性和特异性 

Scientific title:

Validation of the sensitivity and specialty of Chinese version 3D-CAM 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

穆东亮 

研究负责人:

王东信 

Applicant:

Mu Dongliang 

Study leader:

Wang Dongxin 

申请注册联系人电话:

Applicant telephone:

+86 010 83575138 

研究负责人电话:

Study leader's telephone:

+86 010 83575138 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

mudongliang@icloud.com 

研究负责人电子邮件:

Study leader's E-mail:

wangdongxin@hotmail.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

北京市西城区西什库大街8号北京大学第一医院第二住院部麻醉科 

研究负责人通讯地址:

北京市西城区西什库大街8号北京大学第一医院第二住院部麻醉科 

Applicant address:

Department of anesthesiology, Peking University FIrst Hospital, 8 Xishiku Street, Beijing 

Study leader's address:

Department of anesthesiology, Peking University FIrst Hospital, 8 Xishiku Street, Beijing 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

北京大学第一医院 

Applicant's institution:

Peking University First Hospital 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

2017[1321] 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

北京大学第一医院临床研究伦理委员会 

Name of the ethic committee:

Clinical research ethics committee of Peking Univeristy First Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-04-12 

伦理委员会联系人:

朱烟朦 

Contact Name of the ethic committee:

Zhu Yanmeng 

伦理委员会联系地址:

北京市西城区西什库大街8号 

Contact Address of the ethic committee:

8 Xishiku Street, Xicheng District, Beijing 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

北京大学第一医院 

Primary sponsor:

Peking University First Hospital 

研究实施负责(组长)单位地址:

北京市西城区西什库大街8号 

Primary sponsor's address:

8 Xishiku Street, Beijing 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京大学第一医院

具体地址:

北京市西城区西什库大街8号

Institution
hospital:

Peking University First Hospital

Address:

8 Xishiku Street, Beijing

经费或物资来源:

北京大学第一医院麻醉科科研基金 

Source(s) of funding:

Research fund of department of anesthesiology, Peking University First Hosptial 

研究疾病:

谵妄 

Target disease:

Delirium 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

验证中文版3D-CAM的敏感性和特异性 

Objectives of Study:

Validation of the sensitivity and specialty of Chinese version 3D-CAM 

药物成份或治疗方案详述:

3D-CAM (3 minutes confusion assessment method)是一种用于评估患者谵妄的量表,我们将其英文版内容进行了中文翻译。本研究主要是验证3D-CAM中文版的敏感性和特异性。两名非精神科医生负责使用3D-CAM评估患者是否发生了谵妄。一名精神科医生负责使用美国精神疾病诊断手册评估患者是否发生了谵妄。我们将精神科医生的评估结果作为金标准,比较两名非精神科医生使用3D-CAM评估谵妄与金标准之间的敏感性和特异性。 

Description for medicine or protocol of treatment in detail:

3D-CAM is designedd for diagnosis of delirium. We translated its original version into Chinese. This study was designed to validate the sensitivity and spelciaty of Chinese version 3D-CAM in surgical ICU patients. Two non-psyhciatric residents will evaluate if patients suffer delirium by 3D-CAM. A special psyhiatrist will evaluated patietns at the same time by American psychiatric disease diagnostic and statistic mannual, and this result will be considered as "gold standard". The evaluation result of two non-psychiatric resident and sepcial psychiatrist will be compared to analyze sensitivity and specialty. 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

1)ICU内患者;2)年龄大于18岁;3)预期住院时间大于48小时 

Inclusion criteria

1. admission in ICU; 2. aged>18 years; 3. expect in-hospital length >48 hours. 

排除标准:

1)拒绝参加本研究;2)既往有严重痴呆、精神分裂症、癫痫、帕金森病或其他影响交流的脑部疾病;3)视力障碍、听力障碍、气管插管等影响交流;4)昏迷和深度镇静无法进行交流 

Exclusion criteria:

1. refuse to participatation; 2. history of dementia, eclipse, Pakinson's disease or other disease impeding communication; 3. poor vision/hearing or endotracheal intubation impeding communication; 4. coma or deep sedation. 

研究实施时间:

Study execute time:

From2017-04-12To 2017-12-31 

征募观察对象时间:

Recruiting time:

From2017-07-06To 2017-12-31 

干预措施:

Interventions:

组别:

样本量:

245

Group:

No

Sample size:

干预措施:

干预措施代码:

Intervention:

No

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京大学第一医院 

单位级别:

三级甲等 

Institution
hospital:

Peking University First Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

谵妄

指标类型:

主要指标 

Outcome:

Delirium

Type:

Primary indicator 

测量时间点:

术后3天

测量方法:

3D-CAM 和 DSM

Measure time point of outcome:

Postopertive 3 days

Measure method:

3D-CAM and DSM

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

No

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

未使用

Randomization Procedure (please state who generates the random number sequence and by what method):

Not used

盲法:

所有评估者均独立完成谵妄评估,研究期间互相不知道对方的结果

Blinding:

All researchers have to complete evaluation independently, and they don't know each other's result during study period

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

2018年6月以论文方式公布

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

Data and protocol will be shared by thesis at June 2018

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

所有数据由北京大学第一医院麻醉科保管

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

All data will be saved by department of anesthesiology, Peking University First Hospital

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2017-07-06
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