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Effectiveness of the Temporary Positive Expiratory Pressure versus Positive Expiratory Pressure Mask in patients with severe and very severe Chronic obstructive pulmonary disease : a pilot study
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注册号：

Registration number：

 ChiCTR-IPR-17012885 

最近更新日期：

Date of Last Refreshed on：

 2017-10-04 

注册时间：

Date of Registration：

2017-10-04 

注册号状态：

预注册  

Registration Status：

Prospective registration  

注册题目：

Effectiveness of the Temporary Positive Expiratory Pressure versus Positive Expiratory Pressure Mask in patients with severe and very severe Chronic obstructive pulmonary disease : a pilot study  

Public title：

Effectiveness of the Temporary Positive Expiratory Pressure versus Positive Expiratory Pressure Mask in patients with severe and very severe Chronic obstructive pulmonary disease : a pilot study  

注册题目简写：

 

English Acronym：

TPEP versus PEP mask in COPD patients 

研究课题的正式科学名称：

Effectiveness of the Temporary Positive Expiratory Pressure versus Positive Expiratory Pressure Mask in patients with severe and very severe Chronic obstructive pulmonary disease : a pilot study  

Scientific title：

Effectiveness of the Temporary Positive Expiratory Pressure versus Positive Expiratory Pressure Mask in patients with severe and very severe Chronic obstructive pulmonary disease : a pilot study  

研究课题代号(代码)：

Study subject ID：

COPD 

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：

Nicolini Antonello 

研究负责人：

Petrilli Mario 

Applicant：

Nicolini Antonello 

Study leader：

Petrilli Mario 

申请注册联系人电话：

Applicant telephone：

+39 3495952294 

研究负责人电话：

Study leader's telephone：

+39 3495952294 

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：

antonellonicolini@alice.it 

研究负责人电子邮件：

Study leader's E-mail：

mpetrilli@dongnocchi.it 

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, Italy 

研究负责人通讯地址：

Santa Maria La Pineta, Marina di Massa, Italy 

Applicant address：

via terzi 43, Italy 

Study leader's address：

Santa Maria La Pineta, Marina di Massa, Italy 

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：

respiratory diseases unit hospital of sestri levante 

Applicant's institution：

respiratory diseases unit hospital of sestri levante 

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：

Don Gnocchi Foundation 

Primary sponsor：

Don Gnocchi Foundation 

研究实施负责（组长）单位地址：

santa maria La Pineta, Marina di Massa, Italy 

Primary sponsor's address：

santa maria La Pineta, Marina di Massa, Italy 

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

N/A 

Source(s) of funding：

na 

研究疾病：

Chronic obstructive pulmonary disease 

Target disease：

Chronic obstructive pulmonary disease 

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：

探索性研究/预试验 

Study phase：

0 

研究目的：

Comparison between two bronchial airway clearance techniques in patients with COPD. Study of safety and effectiveness 

Objectives of Study：

Comparison between two bronchial airway clearance techniques in patients with COPD. Study of safety and effectiveness 

药物成份或治疗方案详述：

No medicine protocol Twenty COPD patients are randomized and assigned to treatment with temporary expiratory pressure device ( T-PEP ) or positive expiratory pressure mask (PEP mask) Respiratory functional parameters,and dyspnea measurement are evaluated before and after treatment The treatment duration is 30 minutes twice a day and will last 4 weeks  

Description for medicine or protocol of treatment in detail：

No medicine protocol Twenty COPD patients are randomized and assigned to treatment with temporary expiratory pressure device ( T-PEP ) or positive expiratory pressure mask (PEP mask) Respiratory functional parameters,and dyspnea measurement are evaluated before and after treatment The treatment duration is 30 minutes twice a day and will last 4 weeks  

研究设计：

随机平行对照 

Study design：

Parallel 

纳入标准：

Patient with history of asthma, bronchiectasis, previously exacerbation of COPD (no hospital admissions in the previous 2 months or use of antibiotics). 

Inclusion criteria

Patient with history of asthma, bronchiectasis, previously exacerbation of COPD (no hospital admissions in the previous 2 months or use of antibiotics). 

排除标准：

Severe COPD patients (FEV1 1 <50% GOLD stage 3 and 4) with no exacerbation (stable COPD) not signed informed consent; respiratory allergy; tracheostomy; patients with long term oxygen therapy. 

Exclusion criteria：

Severe COPD patients (FEV1 1 <50% GOLD stage 3 and 4) with no exacerbation (stable COPD) not signed informed consent; respiratory allergy; tracheostomy; patients with long term oxygen therapy. 

研究实施时间：

Study execute time：

从From2017-10-04至To 2017-12-04 

征募观察对象时间：

Recruiting time：

从From2017-09-04至To 2017-10-04 

干预措施：

Interventions：

组别：

TPEP COPD

样本量：

 11

Group：

TPEP COPD

Sample size：

干预措施：

TPEP physiotherapy

干预措施代码：

Intervention：

TPEP physiotherapy

Intervention code：

组别：

PEP MASK

样本量：

 10

Group：

PEP MASK

Sample size：

干预措施：

PEP mask physiotherapy

干预措施代码：

Intervention：

PEP mask physiotherapy

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 Italy 

省(直辖市)：

  

市(区县)：

  

Country：

 Italy 

Province：

  

City：

 Massa 

单位(医院)：

 Don gnocchi foundation 

单位级别：

 Rehabilitation Institution 

Institution
hospital：

 Don gnocchi foundation  

Level of the institution：

 Rehabilitation Institution 

测量指标：

Outcomes：

指标中文名：

Respiratory functional parameters

指标类型：

主要指标 

Outcome：

Respiratory functional parameters

Type：

Primary indicator 

测量时间点：

at the end of the study

测量方法：

Measure time point of outcome：

at the end of the study

Measure method：

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

 其它 

说明

Fate of sample：

 Others 

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 35 岁 years
最大 Max age 80 岁 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）：

this is a single blind randomization A randomization schedule has been generated by a statiscian not involved in the study usig an online randomization assignment.The statician who will perform the statisticalk analysis is blinded to statistical patients' randomization

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

this is a single blind randomization A randomization schedule has been generated by a statiscian not involved in the study usig an online randomization assignment.The statician who will perform the statisticalk analysis is blinded to statistical patients' randomization

盲法：

Blinding：

A randomization schedule has been generated by a statician not involved in the study usig an online randomization assignment.The statician who will perform the statisticalk analysis is blinded to statistical patients' randomization

试验完成后的统计结果（上传文件）：

Calculated Results ater
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

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）：

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：

data will be manage on a excel sheet

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

data will be manage on a excel sheet

数据与安全监察委员会：

Data and Safety Monitoring Committee：

注册人：

Name of Registration：

 2017-10-04
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