今天是:2019-08-22 星期四

刘立飞医师:该研究的伦理审批文件未上传,请尽快上传。 “改良动态针尖定位”法超声引导小儿下肢动脉穿刺置管
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注册号:

Registration number:

ChiCTR1900023403 

最近更新日期:

Date of Last Refreshed on:

2019-05-25 

注册时间:

Date of Registration:

2019-05-25 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

刘立飞医师:该研究的伦理审批文件未上传,请尽快上传。 “改良动态针尖定位”法超声引导小儿下肢动脉穿刺置管 

Public title:

Modified dynamic needle tip positioning ultrasound guided lower limb artery cannulation in children 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

“改良动态针尖定位”法超声引导小儿下肢动脉穿刺置管 

Scientific title:

Modified dynamic needle tip positioning ultrasound guided lower limb artery cannulation in children 

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:

刘立飞 

研究负责人:

刘立飞 

Applicant:

Lifei Liu 

Study leader:

Lifei Liu 

申请注册联系人电话:

Applicant telephone:

+86 023 63632143 

研究负责人电话:

Study leader's telephone:

+86 023 63632143 

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:

lifeiliu@hospital.cqmu.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

lifeiliu@hospital.cqmu.edu.cn 

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:

重庆市渝中区中山二路136号 

研究负责人通讯地址:

重庆市渝中区中山二路136号 

Applicant address:

136 Second Zhongshan Road, Yuzhong District, Chongqing, China  

Study leader's address:

136 Second Zhongshan Road, Yuzhong District, Chongqing, China  

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:

重庆医科大学附属儿童医院 

Applicant's institution:

Children's Hospital of Chongqing Medical University  

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:

137/2014 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

重庆医科大学附属儿童医院伦理审查委员会 

Name of the ethic committee:

The Institutional Review Board, Children's Hospital of Chongqing Medical University  

伦理委员会批准日期:

Date of approved by ethic committee:

2014-12-31 

伦理委员会联系人:

李映良 

Contact Name of the ethic committee:

The Institutional Review Board, Children's Hospital of Chongqing Medical University  

伦理委员会联系地址:

重庆市渝中区中山二路136号 

Contact Address of the ethic committee:

136 Second Zhongshan Road, Yuzhong District, Chongqing, 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:

重庆医科大学附属儿童医院 

Primary sponsor:

Children's Hospital of Chongqing Medical University  

研究实施负责(组长)单位地址:

重庆市渝中区中山二路136号 

Primary sponsor's address:

136 Second Zhongshan Road, Yuzhong District, Chongqing, China  

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

自筹 

Source(s) of funding:

self - raised funds 

研究疾病:

小儿下肢动脉穿刺 

Target disease:

lower limb artery cannulation 

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:

“改良动态针尖定位”超声引导能否有效引导小儿下肢动脉穿刺。 

Objectives of Study:

To make sure whether the "Modified dynamic needle tip position" can effectively guide the lower limb artery cannulation in children. 

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:

年龄不超过2岁,需行下肢动脉穿刺的患儿。  

Inclusion criteria

Children under 2 years of age who need lower limb artery puncture. 

排除标准:

穿刺部位感染者,穿刺部位有畸形,患儿家属拒绝参与本项研究。  

Exclusion criteria:

Infection at the puncture site, malformation at the puncture site, family members refuse to participate in the study. 

研究实施时间:

Study execute time:

From2019-06-01To 2021-05-31 

干预措施:

Interventions:

组别:

足背动脉组

样本量:

35

Group:

Dorsal pedis artery group

Sample size:

干预措施:

穿刺置管

干预措施代码:

Intervention:

cannulation

Intervention code:

组别:

胫后动脉组

样本量:

35

Group:

Posterior tibial artery group

Sample size:

干预措施:

穿刺置管

干预措施代码:

Intervention:

cannulation

Intervention code:

组别:

股动脉组

样本量:

35

Group:

Femoral artery group

Sample size:

干预措施:

穿刺置管

干预措施代码:

Intervention:

cannulation

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

重庆医科大学附属儿童医院 

单位级别:

三甲 

Institution
hospital:

Children's Hospital of Chongqing Medical University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

置管成功率

指标类型:

主要指标 

Outcome:

success rate of cannulation

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

穿刺耗时

指标类型:

主要指标 

Outcome:

time of cannulation

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

并发症发生率

指标类型:

主要指标 

Outcome:

incidence of complications

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:

No sample

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 0 years
最大 Max age 2 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):

随机数字表法 刘立飞医师:请说明何人使用随机数字表产生随机序列。

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

Table of random number

盲法:

open

Blinding:

open

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):

http://www.chictr.org.cn/searchproj.aspx

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

http://www.chictr.org.cn/searchproj.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:

病例记录表

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

Case Record Form

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-05-25
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