ChiCTR2000029371 版本V1.0 版本创建时间2020/01/26 10:45:13 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2000029371 

最近更新日期：

Date of Last Refreshed on：

 2020-01-26 10:43:25 

注册时间：

Date of Registration：

 2020-01-25 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Effectiveness of the Expiratory flow acceleration technique in the reduction of bronchial exacerbations in patients with Parkinson's disease and swallowing deficiency: a preliminary study

Public title：

Effectiveness of the Expiratory flow acceleration technique in the reduction of bronchial exacerbations in patients with Parkinson's disease and swallowing deficiency: a preliminary study

注册题目简写：

English Acronym：

EFA in Parkinson

研究课题的正式科学名称：

Effectiveness of the Expiratory flow acceleration technique in the reduction of bronchial exacerbations in patients with Parkinson's disease and swallowing deficiency : a preliminary study

Scientific title：

Effectiveness of the Expiratory flow acceleration technique in patients with Parkinson's disease and swallowing deficiency : a preliminary study

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：

Nicolini Antonello 

研究负责人：

Nicolini Antonello 

Applicant：

Nicolini Antonello 

Study leader：

Nicolini Antonello 

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：

 +39 01 85329866

研究负责人传真：

Study leader's fax：

 +39 01 85329866

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：

意大利塞斯特利瓦特总医院呼吸疾病科

Applicant's institution：

Respiratory Diseases Unit, General Hospital Sestri Levante

研究负责人所在单位：

意大利塞斯特利瓦特总医院呼吸疾病科

Affiliation of the Leader：

Respiratory Diseases Unit, General Hospital Sestri Levante

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：

 N/A

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：

COMITATO ETICO, General Hospital Sestri Levante

Name of the ethic committee：

COMITATO ETICO, General Hospital Sestri Levante

伦理委员会批准日期：

Date of approved by ethic committee：

 2013-06-17 00:00:00

伦理委员会联系人：

Dott. Francesco Brunetti

Contact Name of the ethic committee：

Dott. Francesco Brunetti

伦理委员会联系地址：

AZIENDA UNITA’ SANITARIA LOCALE 4 CHIAVARESE Via G.B. Ghio, 9 16043 CHIAVARI

Contact Address of the ethic committee：

AZIENDA UNITA’ SANITARIA LOCALE 4 CHIAVARESE Via G.B. Ghio, 9 16043 CHIAVARI

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：

ASL 4 Chiavarese

Primary sponsor：

ASL 4 Chiavarese

研究实施负责（组长）单位地址：

via GB Ghio 9

Primary sponsor's address：

via GB Ghio 9

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

意大利

省(直辖市)：

Genova

市(区县)：

sestri levante

Country：

Italia

Province：

Genova

City：

sestri levante

单位(医院)：

Hospital Sestri levante

具体地址：

via Terzi 43 Sestri Levante, Italy

Institution
hospital：

Hospital Sestri levante

Address：

via Terzi 43 Sestri Levante, Italy

经费或物资来源：

N/A

Source(s) of funding：

not applicable

研究疾病：

Parkinson's disease  

Target disease：

parkinson's disease

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 回顾性研究 

Study phase：

Retrospective study

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

To investigate the efficacy of the Expiratory Flow Acceleration (EFA) technique, applied using the device Free Aspire, to reduce the incidence of bronchopulmonary infections . Moreover, changes in respiratory function parameters, cough and encumbrance and quality of life scores  

Objectives of Study：

To investigate the efficacy of the Expiratory Flow Acceleration (EFA) technique, applied using the device Free Aspire, to reduce the incidence of bronchopulmonary infections . Moreover, changes in respiratory function parameters, cough and encumbrance and quality of life scores

药物成份或治疗方案详述：

Material and Method Initial assessment - Logeman Protocol - FEES (Fiberoptic Endoscopic Evaluation of Swallowing) - DOSS 

Description for medicine or protocol of treatment in detail：

Material and Method Initial assessment - Logeman Protocol - FEES (Fiberoptic Endoscopic Evaluation of Swallowing) - DOSS - PAS - Pooling Score Treatment 13 patients treated by standard therapy + 12 patients treated by standard therapy EFA? (EFA group) (control group) Final assessment 30 – 60 – 180 days from the first treatment 

纳入标准：

Parkinson's disease in stage III / IV of the Hoehn and
Yahr scale; aged <=80 years, presence at least one of the predictors of the risk of aspiration: dysphagia, dysphonia, abnormal reflex of swallowing, abnormal reflex of cough, cough after swallowing and change of voice after
swallowing ;Dysphagia outcome and severity scale ( DOSS ) score 3-4; Pooling score 5-12; Penetration and Aspiration (PA) scale 4-7;
With ability to collaborate with the study procedures.

Inclusion criteria

Parkinson's disease in stage III / IV of the Hoehn and
Yahr scale; aged <=80 years, presence at least one of the predictors of the risk of aspiration: dysphagia, dysphonia, abnormal reflex of swallowing, abnormal reflex of cough, cough after swallowing and change of voice after
swallowing ;Dysphagia outcome and severity scale ( DOSS ) score 3-4; Pooling score 5-12; Penetration and Aspiration (PA) scale 4-7;
With ability to collaborate with the study procedures.

排除标准：

Unstable clinical conditions that in the opinion of the specialist may invalidate participation in the study; use of non-invasive diurnal and / or nocturnal mechanical ventilation; absence of caregiver; inability to cooperate with the procedures set out in the protocol;
The criteria for drop-out were: therapeutic adherence <=80%, refusal or failure to complete the daily diary, worsening of clinical conditions, withdrawal of consent.

Exclusion criteria：

Unstable clinical conditions that in the opinion of the specialist may invalidate participation in the study; use of non-invasive diurnal and / or nocturnal mechanical ventilation; absence of caregiver; inability to cooperate with the procedures set out in the protocol;
The criteria for drop-out were: therapeutic adherence <=80%, refusal or failure to complete the daily diary, worsening of clinical conditions, withdrawal of consent.

研究实施时间：

Study execute time：

从 From 2015-12-30 00:00:00至 To 2019-12-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2015-12-30 00:00:00 至 To 2019-01-01 00:00:00

干预措施：

Interventions：

组别：

EFA

样本量：

 13

Group：

EFA

Sample size：

干预措施：

EFA and standard therapy

干预措施代码：

Intervention：

EFA and standard therapy

Intervention code：

组别：

standard therapy

样本量：

 12

Group：

Standard therapy

Sample size：

干预措施：

standard therapy

干预措施代码：

Intervention：

standard therapy

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 意大利

省(直辖市)：

 Genova 

市(区县)：

 sestri levante 

Country：

Italia

Province：

Genova

City：

sestri levante

单位(医院)：

 hospital of sestri levante 

单位级别：

 三级医院 

Institution
hospital：

hospital of sestri levante

Level of the institution：

Tertiary Hospital

测量指标：

Outcomes：

指标中文名：

nuber of respiratory infection and quality of life PDQ39s

指标类型：

主要指标

Outcome：

nuber of respiratory infection and quality of life PDQ39s

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Respiratory function tests (FVC, FEV1) , Cough capacity test (PCEF)Questionnaires on quality of life (QoL) (Euro-QOL, ) ,VAS (Visual Analogue Scale) for cough and bronchial encumbrance.,

指标类型：

次要指标

Outcome：

Respiratory function tests (FVC, FEV1) , Cough capacity test (PCEF)Questionnaires on quality of life (QoL) (Euro-QOL, ) ,VAS (Visual Analogue Scale) for cough and bronchial encumbrance.,

Type：

Secondary indicator

测量时间点：

1-3-6 months

测量方法：

Measure time point of outcome：

1-3-6 months

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

No

组织：

Sample Name：

not applicable

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 岁 years
最大 Max age 85 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）：

A randomization schedule was generated by a statistician not involved in the study using an online random permutation generator from htpp://www.randomization.com.The randomization assignment was provided to the recruiting physicians in sealed envelopes. The patients and the investigators who carried out the study

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

A randomization schedule was generated by a statistician not involved in the study using an online random permutation generator from htpp://www.randomization.com.The randomization assignment was provided to the recruiting physicians in sealed envelopes. The patients and the investigators who carried out the study

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

The randomization assignment was provided to the recruiting physicians in sealed envelopes. The patients and the investigators who carried out the study data analysis were blinded to the patients' treatment assignments

Blinding：

The randomization assignment was provided to the recruiting physicians in sealed envelopes. The patients and the investigators who carried out the study data analysis were blinded to the patients' treatment assignments

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

否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）：

Real time access

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

Data collection and metadata available after request to the responsible of the study

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 collection and metadata available after request to the responsible of the study

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

Electronic data available after request

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2020-01-26 10:43:25