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基于物联网的家庭吸氧联合无创正压通气治疗慢阻肺合并慢性呼吸衰竭的随机对照前瞻性研究
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注册号:

Registration number:

ChiCTR1800019536 

最近更新日期:

Date of Last Refreshed on:

2018-11-17 

注册时间:

Date of Registration:

2018-11-17 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

基于物联网的家庭吸氧联合无创正压通气治疗慢阻肺合并慢性呼吸衰竭的随机对照前瞻性研究 

Public title:

A randomized controlled trial for IOT-based family oxygen therapy and NIPPV treatment in COPD with chronic respiratory failure 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于物联网的家庭吸氧联合无创正压通气治疗慢阻肺合并慢性呼吸衰竭的随机对照前瞻性研究 

Scientific title:

A randomized controlled trial for IOT-based family oxygen therapy and NIPPV treatment in COPD with chronic respiratory failure 

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:

宋元林 

研究负责人:

宋元林 

Applicant:

Song Yuanlin 

Study leader:

Song Yuanlin 

申请注册联系人电话:

Applicant telephone:

+86 15021757762 

研究负责人电话:

Study leader's telephone:

+86 15021757762 

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:

ylsong70@163.com 

研究负责人电子邮件:

Study leader's E-mail:

ylsong70@163.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:

上海市枫林路180号,复旦大学附属中山医院,9号楼4楼 

研究负责人通讯地址:

上海市枫林路180号,复旦大学附属中山医院,9号楼4楼 

Applicant address:

180 Fenglin Road, Shanghai, China 

Study leader's address:

180 Fenglin Road, Shanghai, China 

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:

复旦大学附属中山医院 

Applicant's institution:

Zhongshan Hospital affiliated to Fudan 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:

B2017-176R 

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:

复旦大学附属中山医院伦理委员会 

Name of the ethic committee:

Medical ethics committee of Zhongshan Hospital Affiliated to Fudan University  

伦理委员会批准日期:

Date of approved by ethic committee:

2018-02-06 

伦理委员会联系人:

秦新裕 

Contact Name of the ethic committee:

Qin Xinyu 

伦理委员会联系地址:

上海市枫林路180号 5号楼412室 

Contact Address of the ethic committee:

Room 412, 5th Building, 180 Fenglin Road, Shanghai, 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:

复旦大学附属中山医院 

Primary sponsor:

Zhongshan Hospital Affiliated to Fudan University  

研究实施负责(组长)单位地址:

上海市枫林路180号 

Primary sponsor's address:

180 Fenglin Road, Shanghai, 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):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

复旦大学附属中山医院

具体地址:

上海市枫林路180号

Institution
hospital:

Zhongshan Hospital Affiliated to Fudan University

Address:

180 Fenglin Road, Shanghai

经费或物资来源:

法液空医疗用品(北京)有限公司资助 

Source(s) of funding:

Finicanced by Air Liquide Medical Supplies (Beijing) Co., Ltd 

研究疾病:

慢性阻塞性肺疾病 

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:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

应用基于物联网的长期家庭吸氧联合无创正压通气治疗合并慢性呼吸衰竭的慢阻肺居家患者进行疾病管理,评价其健康相关的生存质量方面的有效性和安全性。 

Objectives of Study:

To evaluate the effectiveness (in terms of Health related Quality of Life) and safety of the home patients management based on internet of things of long-term home oxygen inhalation combined with noninvasive positive pressure ventilation for the treatment of chronic obstructive pulmonary disease patients with chronic respiratory failure. 

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:

1. 40岁~80岁,性别不限; 2. 明确诊断的重度或极重度慢阻肺患者:吸入支气管舒张剂后,FEV1/FVC<70%,FEV1%预计值<50%; 3. 合并有慢性呼吸衰竭:慢阻肺稳定期吸空气状态、静息状态下下列其中一条, a.I型呼吸衰竭:动脉血气分析PaO2 ≤55mmHg 或指脉氧饱和度SpO2 ≤88%;或者动脉血气分析PaO2 55mmHg~60mmHg,或指脉氧饱和度SpO2 88%,伴有右心衰竭或红细胞增多症(红细胞比容>55%);经鼻导管或面罩吸氧治疗仍无法纠正低氧血症者。 b.II型呼吸衰竭:动脉血气分析PaCO2>50mmHg。 

Inclusion criteria

1. Aged 40 to 80 years old, male or female; 2. Clearly diagnosed patients with severe or very severe COPD: FEV1 / FVC <70% and FEV1% <50% predicted value after bronchodilator inhalation; 3. Combined with chronic respiratory failure: patients in the steady state of COPD, breathing ambient air at rest, have one of the following: (1) Type I respiratory failure: arterial blood gas analysis PaO2 ≤ 55mmHg or pulse oxygen saturation SpO2 ≤ 88%; or arterial blood gas analysis PaO2 55mmHg ~ 60mmHg, or pulse oxygen saturation SpO2 88%, with right heart failure or polycythemia (hematocrit> 55%); and nasal catheter or mask oxygen therapy can not correct hypoxemia; (2) Type II respiratory failure: Arterial blood gas analysis PaCO2> 50mmHg. 

排除标准:

1. 心脏血流动力学不稳定患者,如急性左心衰,不稳定型心绞痛; 2. 合并有典型肺纤维化、气道内肿瘤、结核后遗症(毁损肺)等肺病疾病; 3. 患有神经肌肉疾病及严重脑血管意外后遗症者。 

Exclusion criteria:

1. Unstable cardiac hemodynamics, such as acute left heart failure, unstable angina,etc; 2. Combined with typical pulmonary fibrosis, airway tumors, tuberculosis sequelae (lung damage) and other lung diseases; 3. Combined with neuromuscular diseases and or severe cerebrovascular accident sequelae. 

研究实施时间:

Study execute time:

From2018-12-01To 2021-08-31 

征募观察对象时间:

Recruiting time:

From2018-12-01To 2019-12-31 

干预措施:

Interventions:

组别:

无创机械通气+氧疗组

样本量:

100

Group:

NIPPV+Oxygen group

Sample size:

干预措施:

无创正压通气联合家庭氧疗

干预措施代码:

Intervention:

Noninvasive positive pressure ventilation and family oxygen therapy

Intervention code:

组别:

无创机械通气+氧疗+物联网组

样本量:

100

Group:

NIPPV+Oxygen+IOT group

Sample size:

干预措施:

无创正压通气、家庭氧疗和物联网

干预措施代码:

Intervention:

Noninvasive positive pressure ventilation, family oxygen therapy and Internet of thing

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海市浦东医院 

单位级别:

二级甲等 

Institution
hospital:

Shanghai Pudong Hosptial  

Level of the institution:

Secondary A Hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海市青浦区中心医院 

单位级别:

三级乙等 

Institution
hospital:

Shanghai Qingpu District Central Hospital  

Level of the institution:

Tertiary B Hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海市嘉定区中心医院 

单位级别:

二级甲等 

Institution
hospital:

Shanghai Jiading District Central Hospital  

Level of the institution:

secondary A Hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shnaghai 

City:

 

单位(医院):

上海市闵行区中心医院 

单位级别:

二级甲等 

Institution
hospital:

Shanghai Minhang District Central Hospital  

Level of the institution:

Secondary A Hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

SHanghai 

City:

 

单位(医院):

上海市徐汇区中心医院 

单位级别:

二级甲等 

Institution
hospital:

Shanghai Xuhui District Central Hospital  

Level of the institution:

Secondary A Hospital 

测量指标:

Outcomes:

指标中文名:

严重呼吸功能不全问卷

指标类型:

主要指标 

Outcome:

Severe respiratory insufficieny questionaire

Type:

Primary indicator 

测量时间点:

测量方法:

问卷

Measure time point of outcome:

Measure method:

questionnaire survey

指标中文名:

血气分析

指标类型:

次要指标 

Outcome:

Blood gas analysis

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺功能

指标类型:

次要指标 

Outcome:

Pulmonary function

Type:

Secondary indicator 

测量时间点:

测量方法:

肺功能测定

Measure time point of outcome:

Measure method:

spirometry

指标中文名:

CAT 评分

指标类型:

次要指标 

Outcome:

CAT score

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

mMRC评分

指标类型:

次要指标 

Outcome:

mMRC score

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

cNAT 评分

指标类型:

次要指标 

Outcome:

cNAT score

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

6 分钟步行距离及Borg 评分

指标类型:

次要指标 

Outcome:

6 minute walk distance and Borg score

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

短期无创通气耐受率

指标类型:

次要指标 

Outcome:

Short term non-invasive ventilation tolerance rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

急性加重次数

指标类型:

次要指标 

Outcome:

number of acute exacerbation

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

急性加重需要接受住院治疗的次数和天数

指标类型:

次要指标 

Outcome:

The number and duration of hospitalization required for acute exacerbation

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

急性发作需要接受ICU 治疗的次数和天数

指标类型:

次要指标 

Outcome:

The number and duration of ICU treatment required for acute exacerbation

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生存率

指标类型:

次要指标 

Outcome:

survival rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

急性加重需接受住院治疗费用

指标类型:

次要指标 

Outcome:

Hospitalization costs for acute exacerbation

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

急性加重需接受ICU 治疗费用

指标类型:

次要指标 

Outcome:

ICU treatment costs for acute exacerbation

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

各访视时间点患者脱落率

指标类型:

次要指标 

Outcome:

Patients' drop off rate at each visit time point

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:

血液

组织:

Sample Name:

blood

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 40 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):

统计师运用统计软件,生成随机数字分组表。

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

Statistists use statistical software to generate random number table.

盲法:

未说明

Blinding:

Not stated

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

是Yes

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):

专用电子数据收集数据库,在论文发表后6月内公布。

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

A dedicated EDC database within six month after the publication of the papers

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:

建立专用电子数据平台,进行数据保存与管理。

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

Establish a dedicated electronic data platform for data storage and management.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2018-11-17
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