今天是:2019-09-17 星期二

成人外周静脉留置针集束化护理方案“Gets+PIVCs”的构建和实施:随机对照试验
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注册号:

Registration number:

ChiCTR1900025260 

最近更新日期:

Date of Last Refreshed on:

2019-08-18 

注册时间:

Date of Registration:

2019-08-18 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

成人外周静脉留置针集束化护理方案“Gets+PIVCs”的构建和实施:随机对照试验 

Public title:

The construction and implementation of 'Gets+PIVCs' care bundle in adult patients with peripheral intravenous catheter: a randomized controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

成人外周静脉留置针集束化护理方案的构建 

Scientific title:

Construction of the adult peripheral intravenous catheter care bundle 

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:

刘录 

研究负责人:

王薇 

Applicant:

Liu Lu 

Study leader:

Wang Wei 

申请注册联系人电话:

Applicant telephone:

+86 18758016364 

研究负责人电话:

Study leader's telephone:

+86 13777826581 

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:

18758016364@163.com 

研究负责人电子邮件:

Study leader's E-mail:

wangw2005@zju.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:

浙江省杭州市上城区庆春路79号 

研究负责人通讯地址:

浙江省杭州市上城区庆春路79号 

Applicant address:

79 Qingchun, Hangzhou, Zhejiang, China 

Study leader's address:

79 Qingchun, Hangzhou, Zhejiang, China 

申请注册联系人邮政编码:

Applicant postcode:

310003 

研究负责人邮政编码:

Study leader's postcode:

310003 

申请人所在单位:

浙江大学医学院附属第一医院 

Applicant's institution:

The First Affiliated Hospital, College of Medicine, Zhejiang 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:

2019 

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:

浙江大学医学院附属第一医院 科研伦理审查委员会 

Name of the ethic committee:

Approval Letter of Research Ethics Committee of the First Affiliated Hospital, College of Medicine, Zhejiang University  

伦理委员会批准日期:

Date of approved by ethic committee:

2019-05-03 

伦理委员会联系人:

殷琳 

Contact Name of the ethic committee:

Lin Yin 

伦理委员会联系地址:

浙江省杭州市上城区庆春路79号 

Contact Address of the ethic committee:

79 Qingchun, Hangzhou, Zhejiang, 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:

浙江大学医学院附属第一医院 

Primary sponsor:

The First Affiliated Hospital, College of Medicine, Zhejiang University 

研究实施负责(组长)单位地址:

浙江省杭州市上城区庆春路79号 

Primary sponsor's address:

79 Qingchun, Hangzhou, Zhejiang, China 

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):

杭州

Country:

China

Province:

Zhejiang

City:

hangzhou

单位(医院):

浙江大学医学院附属第一医院

具体地址:

浙江省杭州市上城区庆春路79号

Institution
hospital:

The First Affiliated Hospital, College of Medicine, Zhejiang University

Address:

79 Qingchun, Hangzhou

经费或物资来源:

浙江省公益基金 

Source(s) of funding:

Zhejiang Public Welfare Fund 

研究疾病:

不限制 

Target disease:

no limit 

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:

构建并实施成人外周静脉留置针集束化护理方案,改善成人外周静脉留置针的穿刺和维护过程。 

Objectives of Study:

The construction and implementation of "GETs+PIVCs" care bundle in adult patients with peripheral intravenous catheter to improve the insertion and maintenance process of adult peripheral intravenous catheter 

药物成份或治疗方案详述:

不涉及药物 

Description for medicine or protocol of treatment in detail:

No drugs involved 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1.患者大于18岁 2.患者有留置针怎需求 3.患者目标留置时长≥3天 4.自愿参本研究 

Inclusion criteria

1. Patients age >18 years; 2. Patients with PIVC needs; 3. PIVC target dwelling time >=3days 4. Volunteer to participate in this survey. 

排除标准:

1.精神疾病患者 2.凝血功能异常患者 

Exclusion criteria:

1. Mental illness patients; 2. Patients with abnormal coagulation 

研究实施时间:

Study execute time:

From2019-08-19To 2019-09-30 

干预措施:

Interventions:

组别:

Group 2

样本量:

150

Group:

Group 2

Sample size:

干预措施:

采用外周静脉留置针集束化护理方案

干预措施代码:

Intervention:

implementation of "GETs+PIVCs" care bundle in adult patients with peripheral intravenous catheter

Intervention code:

组别:

Group 1

样本量:

150

Group:

Group 1

Sample size:

干预措施:

常规护理方法

干预措施代码:

Intervention:

Conventional nursing

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江省 

市(区县):

杭州市 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

浙江大学医学院附属第一医院 

单位级别:

三甲医院 

Institution
hospital:

The First Affiliated Hospital, College of Medicine,Zhejiang University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

首次穿刺成功率

指标类型:

主要指标 

Outcome:

First PIVC attempt success rate

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:

Complications during indwelling

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

患者满意度

指标类型:

次要指标 

Outcome:

Patient's satisfaction about PIVC insertion and management

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

留置针的留置时长

指标类型:

主要指标 

Outcome:

PIVC indwelling time

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:

无需采集

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):

由科研人员采用随机数表生成随机序列

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

Random numbers generated by researchers using random numbers tables

盲法:

未说明

Blinding:

Not stated

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):

2021年

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

2021

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:

填写问卷采集信息

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

Fill in the questionnaire to collect information

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-08-18
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