ChiCTR2200066749 版本V1.2 版本创建时间2023/07/15 19:21:00 中国临床试验注册中心

审核状态:

Project audit state:

通过审核

Successful

注册号:

Registration number:

ChiCTR2200066749 

最近更新日期:

Date of Last Refreshed on:

2023-05-19 18:59:45 

注册时间:

Date of Registration:

2022-12-15 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

麻醉医师对术后认知功能障碍的认识、态度与实践

Public title:

Knowledge, attitude and practice(KAP) of anesthesiologists on postoperative cognitive dysfunction(POCD)

注册题目简写:

English Acronym:

研究课题的正式科学名称:

麻醉医师对术后认知功能障碍的认识、态度与实践

Scientific title:

Knowledge, attitude and practice(KAP) of anesthesiologists on postoperative cognitive dysfunction(POCD)

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:

胡立 

研究负责人:

胡立 

Applicant:

Hu Li 

Study leader:

Hu Li 

申请注册联系人电话:

Applicant telephone:

13967370064

研究负责人电话:

Study leader's
telephone:

18257333506

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:

253282605@qq.com

研究负责人电子邮件:

Study leader's E-mail:

253282605@qq.com

申请单位网址(自愿提供):

Applicant website(voluntary supply):

嘉兴学院附属第二医院

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:

嘉兴市环城北路1518号

研究负责人通讯地址:

嘉兴市环城北路1518号

Applicant address:

No. 1518, Huancheng North Road, Jiaxing

Study leader's address:

No. 1518, Huancheng North Road, Jiaxing

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:

嘉兴学院附属第二医院

Applicant's institution:

The Second Affiliated Hospital of Jiaxing University

研究负责人所在单位:

嘉兴学院附属第二医院

Affiliation of the Leader:

The Second Affiliated Hospital of Jiaxing University

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

JXEYSW003

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:

嘉兴学院附属第二医院伦理委员会

Name of the ethic committee:

Ethics Committee of the Second Affiliated Hospital of Jiaxing University

伦理委员会批准日期:

Date of approved by ethic committee:

2022-12-07 00:00:00

伦理委员会联系人:

刘冬梅

Contact Name of the ethic committee:

Liu Dongmei

伦理委员会联系地址:

嘉兴市环城北路1518号

Contact Address of the ethic committee:

No. 1518, Huancheng North Road, Jiaxing

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:

嘉兴学院附属第二医院

Primary sponsor:

The Second Affiliated Hospital of Jiaxing University

研究实施负责(组长)单位地址:

嘉兴市环城北路1518号

Primary sponsor's address:

No. 1518, Huancheng North Road, Jiaxing

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

浙江省

市(区县):

Country:

china

Province:

zhejiang

City:

单位(医院):

嘉兴学院附属第二医院

具体地址:

嘉兴市环城北路1518号

Institution
hospital:

The Second Affiliated Hospital of Jiaxing University

Address:

No. 1518, Huancheng North Road, Jiaxing

经费或物资来源:

浙江省医药卫生科技计划

Source(s) of funding:

Zhejiang medical and health science and technology plan

研究疾病:

术后认知功能障碍  

Target disease:

postoperative cognitive dysfunction(POCD)

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:

探索性研究/预试验 

Study phase:

0

研究设计:

横断面 

Study design:

Cross-sectional 

研究目的:

探究麻醉医师对术后认知功能障碍的认识、态度与实践  

Objectives of Study:

To explore the knowledge, attitude and practice of anesthesiologists on postoperative cognitive dysfunction

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

1)从事的专业为麻醉科医师

Inclusion criteria

1) Specializing in anesthesiologists

排除标准:

1)拒绝参加研究;2)完成问卷时间低于1分钟;3)漏项或者逻辑错误。

Exclusion criteria:

1) Refusing to participate in the study; 2) The time to complete the questionnaire is less than 1 minute; 3) Missing item or logic error.

研究实施时间:

Study execute time:

From 2022-12-19 00:00:00 To 2024-01-14 00:00:00  

征募观察对象时间:

Recruiting time:

From 2022-12-19 00:00:00 To 2023-01-14 00:00:00

干预措施:

Interventions:

组别:

观察组

样本量:

400

Group:

Observation group

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

浙江 

市(区县):

 

Country:

china

Province:

Zhejiang

City:

单位(医院):

嘉兴学院附属第二医院 

单位级别:

三级甲等 

Institution
hospital:

The Second Affiliated Hospital of Jiaxing University

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

麻醉医师对POCD的知识

指标类型:

主要指标

Outcome:

Knowledge of anesthesiologists on POCD

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

Online questionnaire

指标中文名:

麻醉医师对POCD的态度

指标类型:

主要指标

Outcome:

attitude of anesthesiologists on POCD

Type:

Primary indicator

测量时间点:

测量方法:

网络问卷

Measure time point of outcome:

Measure method:

Online questionnaire

指标中文名:

麻醉医师对POCD的实践

指标类型:

主要指标

Outcome:

practice of anesthesiologists on POCD

Type:

Primary indicator

测量时间点:

测量方法:

网络问卷

Measure time point of outcome:

Measure method:

Online questionnaire

指标中文名:

基线资料

指标类型:

次要指标

Outcome:

Baseline data of respondents

Type:

Secondary indicator

测量时间点:

测量方法:

网络问卷

Measure time point of outcome:

Measure method:

Online questionnaire

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

none

Tissue:

人体标本去向

使用后销毁  

说明

Fate of sample:

Destruction after use  

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 80 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):

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

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法:

Blinding:

是否共享原始数据:

IPD sharing

否No

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):

问卷星网站

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

https://www.wjx.cn/login.aspx

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:

-

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

-

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2022-12-15 17:21:30