Today is 2020-07-15

Clinical Application of ECMO in the Treatment of Patients with Very Serious Respiratory Failure due to novel Coronavirus Pneumonia (COVID-19)
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注册号:

Registration number:

ChiCTR2000029804 

最近更新日期:

Date of Last Refreshed on:

2020-02-14 

注册时间:

Date of Registration:

2020-02-14 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

体外膜肺氧合技术救治2019新型冠状病毒肺炎(COVID-19)极危重呼吸衰竭患者的临床应用研究 

Public title:

Clinical Application of ECMO in the Treatment of Patients with Very Serious Respiratory Failure due to novel Coronavirus Pneumonia (COVID-19) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

重症病人救治及诊疗方案优化 

Scientific title:

Optimization of treatment and diagnosis plan for critically ill patients 

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:

刘颖 

研究负责人:

吴文娟 

Applicant:

Liu Ying 

Study leader:

Wu Wenjuan 

申请注册联系人电话:

Applicant telephone:

+86 27-85509088 

研究负责人电话:

Study leader's telephone:

+86 13397192695 

申请注册联系人传真 :

Applicant Fax:

+86 27-85509002 

研究负责人传真:

Study leader's fax:

+86 27-85509002 

申请注册联系人电子邮件:

Applicant E-mail:

whsjytyy_gcp@163.com 

研究负责人电子邮件:

Study leader's E-mail:

1346801465@qq.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:

湖北省武汉市东西湖区银潭路1号 

研究负责人通讯地址:

湖北省武汉市东西湖区银潭路1号 

Applicant address:

1 Yintan Road, Dongxihu District, Wuhan, Hubei, China 

Study leader's address:

1 Yintan Road, Dongxihu District, Wuhan, Hubei, China 

申请注册联系人邮政编码:

Applicant postcode:

430023 

研究负责人邮政编码:

Study leader's postcode:

430023 

申请人所在单位:

武汉市金银潭医院(武汉市传染病医院) 

Applicant's institution:

Wuhan Jinyintan Hospital (Wuhan Infectious Diseases Hospital)  

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:

KY-2020-10.02 

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:

武汉市传染病医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Wuhan Infectious Disease Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-11 

伦理委员会联系人:

詹海燕 

Contact Name of the ethic committee:

Zhan Haiyan 

伦理委员会联系地址:

湖北省武汉市东西湖区银潭路1号 

Contact Address of the ethic committee:

1 Yintan Road, Dongxihu District, Wuhan, Hubei, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 27-85509839 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

whsjytyy_ec@163.com 

研究实施负责(组长)单位:

武汉市金银潭医院(武汉市传染病医院) 

Primary sponsor:

Wuhan Jinyintan Hospital (Wuhan Infectious Diseases Hospital) 

研究实施负责(组长)单位地址:

湖北省武汉市东西湖区银潭路1号 

Primary sponsor's address:

1 Yintan Road, Dongxihu District, Wuhan, Hubei, 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):

湖北

市(区县):

武汉

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

武汉市金银潭医院(武汉市传染病医院)

具体地址:

湖北省武汉市东西湖区银潭路1号

Institution
hospital:

Wuhan Jinyintan Hospital (Wuhan Infectious Diseases Hospital)

Address:

1 Yintan Road, Dongxihu District, Wuhan City, Hubei Province, China

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Bejing

City:

单位(医院):

首都医科大学附属北京朝阳医院

具体地址:

北京市朝阳区工体南路8号

Institution
hospital:

Bejing Chao-Yang Hospital,Capital Medical University

Address:

8 Workers stadiums Road South, Chaoyang District

经费或物资来源:

国家科学技术部 

Source(s) of funding:

Ministry of Science and Technology of China 

研究疾病:

新型冠状病毒肺炎(COVID-19) 

Target disease:

Novel Coronavirus Pneumonia (COVID-19) 

研究疾病代码:

 

Target disease code:

 

研究类型:

预后研究 

Study type:

Prognosis study 

研究所处阶段:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

通过收集2019年12月后因感染新型冠状病毒肺炎而使用ECMO患者的临床资料,比较早期使用ECMO与晚期使用ECMO患者的预后差异,评价早期应用ECMO是否获益,并分析与ECMO预后相关的危险因素(早期指符合有创通气,在高PEEP、规范俯卧位通气24小时后PaO2/FiO2仍小于100mmHg即给予ECMO治疗的病例,晚期指满足下述标准进而行ECMO治疗:严重的低氧性呼吸衰竭,经有创机械通气治疗后仍难以改善,动脉血气分析符合下列条件之一的患者[6]:i) PaO2/FiO2 < 50 mmHg大于3 小时;ii) PaO2/FiO2 < 80 mmHg 大于 6小时;iii) pH < 7.25 且 PaCO2≥60 mmHg 大于6小时)。 

Objectives of Study:

By collecting clinical data of patients using ECMO due to infection with the novel coronavirus pneumonia after December 2019, comparing the prognostic differences between patients using ECMO at an early stage and those using ECMO at an advanced stage, evaluating whether early application of ECMO benefits, and analyzing the risks associated with the prognosis of ECMO Factors (Early refers to the case of invasive ventilation, high PEEP, normative prone ventilation 24 hours after PaO2 / FiO2 is still less than 100mmHg is given to ECMO treatment, advanced stage refers to meet the following criteria for ECMO treatment: severe hypoxic breathing Failure, which is still difficult to improve after invasive mechanical ventilation, and arterial blood gas analysis meets one of the following conditions [6]: i) PaO2 / FiO2 <50 mmHg greater than 3 hours; ii) PaO2 / FiO2 <80 mmHg greater than 6 hours Iii) pH <7.25 and PaCO2 ≥ 60 mmHg for more than 6 hours). 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

1)符合国家卫生健康委办公厅印发《新型冠状病毒感染的肺炎诊疗方案(试行第四版)》的患者。 2)严重的低氧性呼吸衰竭给予ECMO治疗的患者。 

Inclusion criteria

1. Patients who meet the requirements of the "New Coronavirus Infected Pneumonia Diagnosis and Treatment Scheme (Trial Version 4)" which issued by the General Office of the National Health Commission. 2. ECMO-treated patients with severe hypoxic respiratory failure. 

排除标准:

1)年龄>75岁。 2)心肺复苏术后。 3)伴有其他严重的脏器功能不全(包括严重肝、肾功能不全、上消化道大出血、DIC等)。 

Exclusion criteria:

1. Age> 75 years. 2. After CPR. 3. Accompanied by other serious organ dysfunction (including severe liver and kidney dysfunction, upper gastrointestinal bleeding, DIC, etc.). 

研究实施时间:

Study execute time:

From2020-02-01To 2021-01-31 

干预措施:

Interventions:

组别:

Case series

样本量:

100

Group:

Case series

Sample size:

干预措施:

不涉及

干预措施代码:

Intervention:

NA

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖北 

市(区县):

武汉 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

武汉市金银潭医院(武汉市传染病医院) 

单位级别:

三级医院 

Institution
hospital:

Wuhan Jinyintan Hospital(Wuhan Infectious Diseases Hospital)  

Level of the institution:

Tertiary Hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

武汉 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

武汉市肺科医院 

单位级别:

三级医院 

Institution
hospital:

Wuhan Pulmonary Hospital  

Level of the institution:

Tertiary Hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

武汉 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

武汉大学人民医院 

单位级别:

三级甲等 

Institution
hospital:

Renmin Hospital of Wuhan University  

Level of the institution:

Tertiary Hospital 

测量指标:

Outcomes:

指标中文名:

住院病死率

指标类型:

主要指标 

Outcome:

Inpatient mortality

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

ICU住院时间

指标类型:

次要指标 

Outcome:

ICU hospital stay

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

总住院时间

指标类型:

次要指标 

Outcome:

Total hospital stay

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

ICU病死率

指标类型:

次要指标 

Outcome:

ICU fatality rate

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:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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 Procedure (please state who generates the random number sequence and by what method):

N/A

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

点击下载

Calculated Results ater
the Study Completed(upload file):

download

原始数据公开时间:

The time of sharing IPD:

Within six months after the trial complete

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):

试验完成后6个月内共享

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

Sharing within 6 months after trial completion

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:

病例记录表

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

CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-02-14
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