术中体温管理现状临床调查

注册号:

Registration number:

ChiCTR2100042565 

最近更新日期:

Date of Last Refreshed on:

2021-01-23 13:13:22 

注册时间:

Date of Registration:

2021-01-23 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

术中体温管理现状临床调查

Public title:

Survey of current clinical practice in intraoperative thermal management

注册题目简写:

English Acronym:

研究课题的正式科学名称:

术中体温管理现状临床调查

Scientific title:

Survey of current clinical practice in intraoperative thermal management

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:

石贇 

研究负责人:

石贇 

Applicant:

Yun Shi 

Study leader:

Yun Shi 

申请注册联系人电话:

Applicant telephone:

13918268351

研究负责人电话:

Study leader's
telephone:

13918268351

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:

imulashi@yahoo.com

研究负责人电子邮件:

Study leader's E-mail:

imulashi@yahoo.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:

中国上海闵行区万源路399号

研究负责人通讯地址:

中国上海闵行区万源路399号

Applicant address:

#399 Wanyuan Road, Minhang District, Shanghai, China

Study leader's address:

#399 Wanyuan Road, Minhang District, Shanghai, China

申请注册联系人邮政编码:

Applicant postcode:

201102

研究负责人邮政编码:

Study leader's postcode:

201102

申请人所在单位:

复旦大学附属儿科医院

Applicant's institution:

Children's Hospital of Fudan University

研究负责人所在单位:

Affiliation of the Leader:

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:

复儿伦审(2020)510号

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:

复旦大学附属儿科医院伦理委员会

Name of the ethic committee:

Ethics Committee on Biomedical Research, Children's Hospital of Fudan University

伦理委员会批准日期:

Date of approved by ethic committee:

2020-12-22 00:00:00

伦理委员会联系人:

钱莉玲

Contact Name of the ethic committee:

Liling Qian

伦理委员会联系地址:

中国上海闵行区万源路399号

Contact Address of the ethic committee:

#399 Wanyuan Road, Minhang District, Shanghai, China

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:

复旦大学附属儿科医院

Primary sponsor:

Children's Hospital of Fudan University

研究实施负责(组长)单位地址:

复旦大学附属儿科医院

Primary sponsor's address:

Children's Hospital of Fudan University

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

复旦大学附属儿科医院

具体地址:

中国上海闵行区万源路399号

Institution
hospital:

Children's Hospital of Fudan University

Address:

#399 Wanyuan Road, Minhang District, Shanghai, China

国家:

中国

省(直辖市):

四川

市(区县):

Country:

China

Province:

Sichuan

City:

单位(医院):

四川大学华西医院

具体地址:

成都市武侯区国学巷37号

Institution
hospital:

West China Hospital of Sichuan University

Address:

#37 Guoxue Xiang,Houwu District,Chengdu,China

经费或物资来源:

国家自然科学基金

Source(s) of funding:

National Natural Science Foundation of China

研究疾病:

术中体温管理  

Target disease:

intraoperative temperature management

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

研究设计:

横断面 

Study design:

Cross-sectional 

研究目的:

医护人员对手术患者进行体温管理的现状;医护人员对术中体温管理的认知情况;影响术中体温管理的因素。  

Objectives of Study:

To investigate the current clinical practice in intraoperative thermal management. To investigate the knowledge of the health care workers on the intraoperative thermal management. To identify the factors that may affect the clinical practice in intraoperative thermal management.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

Inclusion criteria

排除标准:

非上述范围的工作人员

Exclusion criteria:

The health care workers who are not within the scope mentioned above.

研究实施时间:

Study execute time:

From 2021-01-01 00:00:00 To 2021-04-01 00:00:00  

征募观察对象时间:

Recruiting time:

From 2021-02-01 00:00:00 To 2021-04-01 00:00:00

干预措施:

Interventions:

组别:

受试者

样本量:

200

Group:

participant

Sample size:

干预措施:

干预措施代码:

Intervention:

NA

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

上海 

市(区县):

 

Country:

China

Province:

Shanghai

City:

单位(医院):

复旦大学附属儿科医院 

单位级别:

三级甲等医院 

Institution
hospital:

Children's Hospital of Fudan University

Level of the institution:

Class 3A

国家:

中国

省(直辖市):

四川 

市(区县):

 

Country:

China

Province:

Sichuan

City:

单位(医院):

四川大学华西医院 

单位级别:

成都市武侯区国学巷37号 

Institution
hospital:

West China Hospital of Sichuan University

Level of the institution:

#37 Guoxue Xiang,Houwu District,Chengdu,China

测量指标:

Outcomes:

指标中文名:

关于术中体温管理的知识储备

指标类型:

主要指标

Outcome:

the knowlege about intraoperative thermal management

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

NA

Tissue:

NA

人体标本去向

其它  

说明

不适用

Fate of sample:

0thers  

Note:

NA

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 20 years
最大 Max age 70 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):

不适用

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

NA

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

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):

临床试验原始数据共享平台

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

http://www.medresman.org.cn/pub/cn/proj/stat/secsponsor.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:

使用星问卷app进行数据采集,使用ResMan进行数据管理

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

Data is collected using the app, named "xingwenjuan", and managed using ResMan

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2021-01-23 13:13:22