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Comparison of two mechanical insufflation-exsufflation techniques in patients with amyotrophic lateral sclerosis : a
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注册号：

Registration number：

 ChiCTR2000030385 

最近更新日期：

Date of Last Refreshed on：

 2020-03-01 02:50:29 

注册时间：

Date of Registration：

 2020-03-01 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Comparison of two mechanical insufflation-exsufflation techniques in patients with amyotrophic lateral sclerosis : a

Public title：

Comparison of two mechanical insufflation-exsufflation techniques in patients with amyotrophic lateral sclerosis : a preliminary study

注册题目简写：

English Acronym：

MI in ALS

研究课题的正式科学名称：

Comparison of two mechanical insufflation-exsufflation techniques in patients with amyotrophic lateral sclerosis : a preliminary study

Scientific title：

Comparison of two mechanical insufflation-exsufflation techniques in patients with amyotrophic lateral sclerosis : 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@alice.it

研究负责人电子邮件：

Study leader's E-mail：

 antonellonicolini@alice.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：

na

研究负责人通讯地址：

na

Applicant address：

via terzi 47 sestri levante

Study leader's address：

via terzi 47 sestri levante

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：

via terzi 47 sestri levante

Applicant's institution：

respiratory diseases unit hospital of sestri levante

研究负责人所在单位：

Affiliation of the Leader：

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：

 597

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 AZIENDA SANITARIA LOCALE N

Name of the ethic committee：

Comitato Etico AZIENDA SANITARIA LOCALE N

伦理委员会批准日期：

Date of approved by ethic committee：

 2017-08-26 00:00:00

伦理委员会联系人：

Dott Faol Cavagnaro

Contact Name of the ethic committee：

Dott Faol Cavagnaro

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：

ASL 4 chiavarese regione liguria

Primary sponsor：

ASL 4 chiavarese regione liguria

研究实施负责（组长）单位地址：

via gb ghio 9 chiavari

Primary sponsor's address：

via gb ghio 9 chiavari

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 47

Institution
hospital：

general hospital

Address：

via terzi 47

经费或物资来源：

na

Source(s) of funding：

na

研究疾病：

amyotrophic lateral sclerosis  

Target disease：

ALS

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：

 上市后药物 

Study phase：

4

研究设计：

半随机对照 

Study design：

Quasi-randomized controlled 

研究目的：

comparison of the effectiveness of two devices for cough assisting in patients with ALS  

Objectives of Study：

comparison of the effectiveness of two devices for cough assisting in patients with ALS

药物成份或治疗方案详述：

PROTOCOL This is a preliminary parallel randomized controlled study comparing two cough- assisting devices. The aim of the study was to verify their effectiveness, safety and the patients' preference regarding the two devices. Patients who met inclusion criteria following a screening visit and were enrolled and randomized in two groups: ? a group was treated with cough assistor with EFA ( Kalos? MPR-Legnano, Italy) ( k group ) ? a group was treated with cough assistor ( mechanical insufflator/exsufflator ) (MI/E group ) (see flow-chart - fig.1) A randomization schedule was generated by a statistician not involved in the study using an online random permutation generator from http.//www.randomization.com. The randomization assignment was provided to the recruiting physician in sealed envelopes.To guarantee the highest blindness, each group of patients were treated by a different chest physiotherapist ignorant about the other assigned treatment. Moreover, the statistician, not involved in the study, as well as the chest physicians were blinded to treatment assignments. Treatment protocol Cough assisting was delivered by a respiratory physiotherapist using cough assistor Insufflation / exsufflation via a breathing tube, a bacterial filter and a face mask. Both the devices were set initially in an automatic mode with the following parameters : insufflation pressure +40 cmH2O , exsufflation pressure -40 cmH2O,insufflation time 3 seconds, exsufflation time 2 seconds with pause 3 seconds . Moreover both insufflatory and exsufflatory pressure were titrated to patient comfort. Each treatment lasted 5 cycles. In addition, in the Kalos group the treatment was preceding by a 30 minutes cycle with EFA set al level 5. Cough assisting treatment was repeated three times every day. In addition the comfort and distress caused by the interventions together with perceived strength of cough were evaluated using a Visual Analogue Scale (VAS) rating comfort of the intervention, distress and strength of cough produced ( 0 .least 10 . most ) The study lasted 36 months and patients were monitored at 1,6,12 months after starting the treatment. The primary outcome was the changes in respiratory function testing, respiratory muscle function tests, gas exchange, and peak cough expiratory flow as indicator of cough efficacy. The secondary outcome was exacerbations after 1, 6 and 12 months, and comfort and distress caused by the interventions together with perceived strength of cough. Acute exacerbation was defined as deterioration of respiratory symptoms (cough, sputum purulence ) , increased dyspnea for >24 h, systemic complaints, such as fever, and an episode of acute respiratory failure. The number of exacerbations were assessed prospectively using patient's clinical records. Pulmonary function testing (PFT) included: forced vital capacity (FVC), forced expiratory volume 1 second (FEV1), FEV1/FVC%, maximal inspiratory pressure (MIP),maximal expiratory pressure (MEP),sniff nasal inspiratory pressure (SNIP) peak cough expiratory flow (PCEF), arterial blood gas (ABG) analysis (paO2, paCO2, pH). PFT was performed with a computerized body plethysmography (VMAX 20 PFT Sensor Medics, Yorba Linda, CA, USA), according to the ATS/ERS Guidelines. Inspiratory muscle strength was assessed by measuring the MIP at RV. Expiratory muscle strength was assessed by measuring the MEP at TLC. The value obtained from the best of at least three efforts was used. All the measurements were obtained in upright position. ABG was measured at rest. Blood samples were analyzed for pH, PaCO2, PaO2 . All the tests were assessed at start of the treatment (T0) a and then one (T1), six (T6) and twelve (T12) month after the start of the treatment (during a follow-up visit). At each follow-up visit a physiotherapist recorded exacerbations and adherence to each cough assistor . 

Description for medicine or protocol of treatment in detail：

PROTOCOL This is a preliminary parallel randomized controlled study comparing two cough- assisting devices. The aim of the study was to verify their effectiveness, safety and the patients' preference regarding the two devices. Patients who met inclusion criteria following a screening visit and were enrolled and randomized in two groups: ? a group was treated with cough assistor with EFA ( Kalos? MPR-Legnano, Italy) ( k group ) ? a group was treated with cough assistor ( mechanical insufflator/exsufflator ) (MI/E group ) (see flow-chart - fig.1) A randomization schedule was generated by a statistician not involved in the study using an online random permutation generator from http.//www.randomization.com. The randomization assignment was provided to the recruiting physician in sealed envelopes.To guarantee the highest blindness, each group of patients were treated by a different chest physiotherapist ignorant about the other assigned treatment. Moreover, the statistician, not involved in the study, as well as the chest physicians were blinded to treatment assignments. Treatment protocol Cough assisting was delivered by a respiratory physiotherapist using cough assistor Insufflation / exsufflation via a breathing tube, a bacterial filter and a face mask. Both the devices were set initially in an automatic mode with the following parameters : insufflation pressure +40 cmH2O , exsufflation pressure -40 cmH2O,insufflation time 3 seconds, exsufflation time 2 seconds with pause 3 seconds . Moreover both insufflatory and exsufflatory pressure were titrated to patient comfort. Each treatment lasted 5 cycles. In addition, in the Kalos group the treatment was preceding by a 30 minutes cycle with EFA set al level 5. Cough assisting treatment was repeated three times every day. In addition the comfort and distress caused by the interventions together with perceived strength of cough were evaluated using a Visual Analogue Scale (VAS) rating comfort of the intervention, distress and strength of cough produced ( 0 .least 10 . most ) The study lasted 36 months and patients were monitored at 1,6,12 months after starting the treatment. The primary outcome was the changes in respiratory function testing, respiratory muscle function tests, gas exchange, and peak cough expiratory flow as indicator of cough efficacy. The secondary outcome was exacerbations after 1, 6 and 12 months, and comfort and distress caused by the interventions together with perceived strength of cough. Acute exacerbation was defined as deterioration of respiratory symptoms (cough, sputum purulence ) , increased dyspnea for >24 h, systemic complaints, such as fever, and an episode of acute respiratory failure. The number of exacerbations were assessed prospectively using patient's clinical records. Pulmonary function testing (PFT) included: forced vital capacity (FVC), forced expiratory volume 1 second (FEV1), FEV1/FVC%, maximal inspiratory pressure (MIP),maximal expiratory pressure (MEP),sniff nasal inspiratory pressure (SNIP) peak cough expiratory flow (PCEF), arterial blood gas (ABG) analysis (paO2, paCO2, pH). PFT was performed with a computerized body plethysmography (VMAX 20 PFT Sensor Medics, Yorba Linda, CA, USA), according to the ATS/ERS Guidelines. Inspiratory muscle strength was assessed by measuring the MIP at RV. Expiratory muscle strength was assessed by measuring the MEP at TLC. The value obtained from the best of at least three efforts was used. All the measurements were obtained in upright position. ABG was measured at rest. Blood samples were analyzed for pH, PaCO2, PaO2 . All the tests were assessed at start of the treatment (T0) a and then one (T1), six (T6) and twelve (T12) month after the start of the treatment (during a follow-up visit). At each follow-up visit a physiotherapist recorded exacerbations and adherence to each cough assistor . 

纳入标准：

Inclusion criteria

排除标准：

Diagnosis of neuromuscular disorders other than ALS presence of tracheostomy severe bulbar involvement inability to perform cough assisting hemoptysis or pneumothorax in the six months preceding the enrollment

Exclusion criteria：

Diagnosis of neuromuscular disorders other than ALS presence of tracheostomy severe bulbar involvement inability to perform cough assisting hemoptysis or pneumothorax in the six months preceding the enrollment

研究实施时间：

Study execute time：

从 From 2017-08-01 00:00:00至 To 2019-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2016-07-29 00:00:00 至 To 2017-07-31 00:00:00

干预措施：

Interventions：

组别：

kalos group

样本量：

 30

Group：

kalos group

Sample size：

干预措施：

cough assisting + expiratory flow accelerator

干预措施代码：

Intervention：

cough assisting + expiratory flow accelerator

Intervention code：

组别：

MI/E group

样本量：

 30

Group：

MI/E GRoup

Sample size：

干预措施：

cough mechanical assisting

干预措施代码：

Intervention：

cough mechanical assisting

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：

单位(医院)：

 respiratory diseases unit hospital sestri levante 

单位级别：

 tertiary 

Institution
hospital：

respiratory diseases unit hospital sestri levante

Level of the institution：

tertiary

测量指标：

Outcomes：

指标中文名：

respiratory function tests

指标类型：

主要指标

Outcome：

respiratory function tests

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

exacerbations

指标类型：

次要指标

Outcome：

exacerbations

Type：

Secondary 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：

na

组织：

na

Sample Name：

na

Tissue：

na

人体标本去向

 使用后销毁  

说明

na

Fate of sample：

Destruction after use  

Note：

na

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）：

Randomization schedule was generated by a statistician not involved in the study using an online random permutation generator from www.randomization.com The assignment was provided to the recruiting physician in sailed envelopes.to guarantee the highest blindness each group of patients were treated by a different physiothe

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

Randomization schedule was generated by a statistician not involved in the study using an online random permutation generator from www.randomization.com The assignment was provided to the recruiting physician in sailed envelopes.to guarantee the highest blindness each group of patients were treated by a different physiothe

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：

see above

Blinding：

see above

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）：

data are available by request

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

data are available by request

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：

an electronic data collection is available

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

an electronic data collection is available

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2020-03-01 02:50:29
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