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请填写伦理审批日期,文件中未标注。 超声双显影线声影引导下桡动脉穿刺置管在麻醉科住院医师规范化培训中的应用
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注册号:

Registration number:

ChiCTR2100046833 

最近更新日期:

Date of Last Refreshed on:

2022-01-10 

注册时间:

Date of Registration:

2021-05-28 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

请填写伦理审批日期,文件中未标注。 超声双显影线声影引导下桡动脉穿刺置管在麻醉科住院医师规范化培训中的应用 

Public title:

Application of Acoustic Shadowing Facilitates Ultrasound-guided Radial Artery Puncture Technique in Standardized Training of Residents in Anesthesiology Department 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

超声双显影线声影引导下桡动脉穿刺置管在麻醉科住院医师规范化培训中的应用 

Scientific title:

Application of Acoustic Shadowing Facilitates Ultrasound-guided Radial Artery Puncture Technique in Standardized Training of Residents in Anesthesiology Department 

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:

陈静燕 

研究负责人:

孙立新 

Applicant:

Chen Jingyan 

Study leader:

Sun Lixin 

申请注册联系人电话:

Applicant telephone:

+86 15797722308 

研究负责人电话:

Study leader's telephone:

+86 15621022955 

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:

691777890@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

sunlixin1221@sina.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:

山东省青岛市市南区东海中路5号 

研究负责人通讯地址:

山东省青岛市市南区东海中路5号 

Applicant address:

5 Donghai Road Middle, Shinan District, Qingdao, Shandong 

Study leader's address:

5 Donghai Road Middle, Shinan District, Qingdao, Shandong 

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:

山东省青岛市市立医院东院区麻醉科 

Applicant's institution:

Department of Anesthesiology, Eastern Compus of Qingdao City Hospital, Shandong  

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:

2021临审字Y第042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:

青岛市市立医院伦理委员会 

Name of the ethic committee:

Clinical Trial Ethics Committee of Qingdao Municipal Hospital  

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

杨九龙 

Contact Name of the ethic committee:

Yang Jiulong 

伦理委员会联系地址:

山东省青岛市市北区胶州路1号 

Contact Address of the ethic committee:

1 Jiaozhou Road, Shibei District, Qingdao, Shandong, 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:

青岛市市立医院 

Primary sponsor:

Qingdao Municipal Hospital  

研究实施负责(组长)单位地址:

山东省青岛市市南区东海中路5号 

Primary sponsor's address:

5 Donghai Road Middle, Shinan District, Qingdao, Shandong  

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

山东

市(区县):

青岛

Country:

China

Province:

Shandong

City:

Qingdao

单位(医院):

青岛市市立医院

具体地址:

市南区东海中路5号

Institution
hospital:

Qingdao Municipal Hospital

Address:

5 DongHai Center Road, Shinan District

经费或物资来源:

国家自然科学基金青年项目(82001132),贝朗麻醉科研基金(BBDF-2019-010) 

Source(s) of funding:

National Natural Science Foundation Youth Project (82001132) and B.Braun Anesthesia Research Fund(BBDF-2019-010) 

研究疾病:

桡动脉穿刺置管 

Target disease:

Radial Artery Puncture Technique 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

评价超声双显影线声影引导下桡动脉穿刺置管在麻醉科住院医师规范化培训中的教学效果。 

Objectives of Study:

To investigate the application of acoustic shadowing facilitates ultrasound-guided radial artery puncture in the standardized training of residents in anesthesiology. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1.在青岛市市立医院住院医师规范化培训基地的第一年住院医师; 2.每位住院医师入科前从未接触或操作过超声引导下桡动脉穿刺置管。 

Inclusion criteria

1. Resident doctors in their first year of the standardized training from Qingdao Municipal Hospital; 2. Each resident that had never received any ultrasound-guided radial artery puncture and catheterization training before admission. 

排除标准:

有工作经验的第一年住院医师。 

Exclusion criteria:

Resident physician for the first year with work experience. 

研究实施时间:

Study execute time:

From2021-07-01To 2022-12-31 

征募观察对象时间:

Recruiting time:

From2021-07-01To 2022-12-31 

干预措施:

Interventions:

组别:

新型超声教学组

样本量:

40

Group:

new ultrasound-guided teaching group

Sample size:

干预措施:

穿刺方法

干预措施代码:

Intervention:

Puncture method

Intervention code:

组别:

传统超声教学组

样本量:

40

Group:

traditional ultrasound-guided group

Sample size:

干预措施:

穿刺方法

干预措施代码:

Intervention:

Puncture method

Intervention code:

组别:

盲探穿刺组

样本量:

40

Group:

blind agent puncture group

Sample size:

干预措施:

采用传统触摸定位

干预措施代码:

Intervention:

Traditional touch positioning

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

山东 

市(区县):

青岛 

Country:

China 

Province:

Shandong 

City:

Qingdao 

单位(医院):

青岛市市立医院 

单位级别:

三级甲等 

Institution
hospital:

Qingdao Municipal Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

年龄

指标类型:

次要指标 

Outcome:

Age

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

性别

指标类型:

次要指标 

Outcome:

Gender

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

入科考试成绩

指标类型:

主要指标 

Outcome:

The success case of cannulation at the first attempt

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

置管成功例数

指标类型:

主要指标 

Outcome:

The success case of catherterization

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

超声定位时间(s)

指标类型:

主要指标 

Outcome:

Ultrasound localization time (s)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

穿刺时间(s)

指标类型:

主要指标 

Outcome:

Puncture time(s)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

局部血肿发生例数

指标类型:

主要指标 

Outcome:

The cases of local hematoma

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:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 22 years
最大 Max age 24 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):

随机数字表

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

Random number table

盲法:

Not stated

Blinding:

Not stated

是否共享原始数据:

IPD sharing

是Yes

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):

通过发表期刊文章公开原始数据 请阅读网页注册指南中关于 原始数据共享 的内容。

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

by publication

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:

以文件方式保存

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

Data will be deposited in paper form and stored in the safe.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2021-05-28
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