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Short-term comparative and follow-up study of two high frequency chest wall oscillation techniques in patients with bronchiectasis (Respin 11 and Smart Vest )
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注册号:

Registration number:

ChiCTR1800017369 

最近更新日期:

Date of Last Refreshed on:

2018-07-26 

注册时间:

Date of Registration:

2018-07-26 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

Short-term comparative and follow-up study of two high frequency chest wall oscillation techniques in patients with bronchiectasis (Respin 11 and Smart Vest ) 

Public title:

Short-term comparative and follow-up study of two high frequency chest wall oscillation techniques in patients with bronchiectasis (Respin 11 and Smart Vest ) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

Short-term comparative and follow-up study of two high frequency chest wall oscillation techniques in patients with bronchiectasis (Respin 11 and Smart Vest ) 

Scientific title:

Short-term comparative and follow-up study of two high frequency chest wall oscillation techniques in patients with bronchiectasis ( Respin 11 and Smart Vest ) 

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:

Antonello Nicolini 

研究负责人:

Antonello Nicolini 

Applicant:

Antonello Nicolini 

Study leader:

Antonello Nicolini 

申请注册联系人电话:

Applicant telephone:

+39 01 85329145 

研究负责人电话:

Study leader's telephone:

+39 01 85329145 

申请注册联系人传真 :

Applicant Fax:

+390185329121 

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:

antonellonicolini@gmail.com 

研究负责人电子邮件:

Study leader's E-mail:

antonellonicolini@gmail.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:

via Terzi 43 Sestri Levante, Italy 

研究负责人通讯地址:

via Terzi 43 Sestri Levante, Italy 

Applicant address:

via Terzi 43 Sestri Levante, Italy 

Study leader's address:

via Terzi 43 Sestri Levante, Italy 

申请注册联系人邮政编码:

Applicant postcode:

16039 

研究负责人邮政编码:

Study leader's postcode:

16039 

申请人所在单位:

Respiratory Diseases Unit, General Hospital 

Applicant's institution:

Respiratory Diseases Unit, General Hospital 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

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:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

ASL4, Chiavari, Italy 

Primary sponsor:

ASL4, Chiavari, Italy 

研究实施负责(组长)单位地址:

via GB ghio 9 16043 Chiavari, Italy 

Primary sponsor's address:

via GB ghio 9 16043 Chiavari, Italy 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

Italy

省(直辖市):

Genova

市(区县):

sestri levante

Country:

Italy

Province:

Genova

City:

sestri levante

单位(医院):

general Hospital

具体地址:

via Terzi 43 Sestri Levante, Italy

Institution
hospital:

general Hospital

Address:

via Terzi 43 Sestri Levante, Italy

经费或物资来源:

Internal funding 

Source(s) of funding:

Internal funding 

研究疾病:

Bronchiectasis 

Target disease:

Bronchiectasis 

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:

Comparison of the effectiveness between two high frequency chest wall oscillation tools (RESPIN 11 and SMART VEST) in patient with bronchiectasis compared with a group of patient treated only with standard medical therapy 

Objectives of Study:

Comparison of the effectiveness between two high frequency chest wall oscillation tools (RESPIN 11 and SMART VEST) in patient with bronchiectasis compared with a group of patient treated only with standard medical therapy  

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:

Patients aging 18 to 80 year with computed tomography confirmed bronchiectasis  

Inclusion criteria

Patients aging 18 to 80 year with computed tomography confirmed bronchiectasis  

排除标准:

Patients with tracheostomy; diagnosis of bronchial asthma; respiratory allergy; patient treated with long term oxygen therapy or non invasive ventilation  

Exclusion criteria:

Patients with tracheostomy; diagnosis of bronchial asthma; respiratory allergy; patient treated with long term oxygen therapy or non invasive ventilation  

研究实施时间:

Study execute time:

From2017-03-01To 2018-03-01 

征募观察对象时间:

Recruiting time:

From2016-09-01To 2017-02-28 

干预措施:

Interventions:

组别:

Group 1

样本量:

21

Group:

Group 1

Sample size:

干预措施:

respin 11 treatment

干预措施代码:

Intervention:

respin 11 treatment

Intervention code:

组别:

Group 2

样本量:

22

Group:

Group 2

Sample size:

干预措施:

smart vest treatment

干预措施代码:

Intervention:

smart vest treatment

Intervention code:

组别:

Group 3

样本量:

20

Group:

Group 3

Sample size:

干预措施:

medical therapy

干预措施代码:

Intervention:

medical therapy

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

Italy 

省(直辖市):

genova 

市(区县):

 

Country:

Italy 

Province:

genova 

City:

sestri levante 

单位(医院):

genral hospital 

单位级别:

secondary 

Institution
hospital:

genral hospital  

Level of the institution:

secondary 

测量指标:

Outcomes:

指标中文名:

exaCERBATIONS

指标类型:

主要指标 

Outcome:

exaCERBATIONS

Type:

Primary indicator 

测量时间点:

3 -6-12 MONTHS

测量方法:

NUMBER

Measure time point of outcome:

3 -6-12 MONTHS

Measure method:

NUMBER

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

N/A

组织:

Sample Name:

NA

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:

结束

Completed

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 85 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):

A randomization schedule has been generated by a statistician not involved in the study using a online htpp.//www.randomization.com.The randomization assigment is provided to the recruiting physician in sealed envelopes.The staticians who performs the statistical analysis is blinded

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

A randomization schedule has been generated by a statistician not involved in the study using a online htpp.//www.randomization.com.The randomization assigment is provided to the recruiting physician in sealed envelopes.The staticians who performs the statistical analysis is blinded

盲法:

The randomization assigment was provided to the recruiting physician in sealed envelopes.The staticians who performed the statical analysis was blindrd to the assignment

Blinding:

The randomization assigment was provided to the recruiting physician in sealed envelopes.The staticians who performed the statical analysis was blindrd to the assignment

试验完成后的统计结果(上传文件):

点击下载

Calculated Results after
the Study Completed(upload file):

download

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

metadata and protocol

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

metadata and protocol

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:

Database of Reespiratory Diseases Unit is of public available

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

Database of Reespiratory Diseases Unit is of public available

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2018-07-26
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