ChiCTR2000031836 版本V1.3 版本创建时间2020/04/11 23:06:47 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：

 ChiCTR2000031836 

最近更新日期：

Date of Last Refreshed on：

 2020-04-11 23:05:08 

注册时间：

Date of Registration：

 2020-04-11 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

2019新型冠状病毒肺炎(COVID-19)致ARDS病例临床特点分析

Public title：

Clinical Characteristics Of Hospitalized Novel Coronavirus Pneumonia (COVID-19) Patients With Acute Respiratory Distress Syndrome

注册题目简写：

English Acronym：

研究课题的正式科学名称：

45例新冠肺炎(COVID-19)致ARDS病例的临床特点：一个单中心回顾性观察研究

Scientific title：

Clinical Characteristics Of 45 Hospitalized Novel Coronavirus Pneumonia (COVID-19) Patients With Acute Respiratory Distress Syndrome: A Single-Centered, Retrospective, Observational 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：

鲁锦志 

研究负责人：

鲁锦志 

Applicant：

Jinzhi Lu 

Study leader：

Jinzhi Lu 

申请注册联系人电话：

Applicant telephone：

 +86 1816313926

研究负责人电话：

Study leader's
telephone：

+86 18163138632

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：

 jinzhilu2015@163.com

研究负责人电子邮件：

Study leader's E-mail：

 jinzhilu2015@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：

中国湖北省荆州市沙市区航空路8号

研究负责人通讯地址：

中国湖北省荆州市沙市区航空路8号

Applicant address：

Department of Laboratory Medicine, The First Affiliated Hospital of Yangtze University, Jingzhou 434400, Hubei, People’s Republic of China

Study leader's address：

Department of Laboratory Medicine, The First Affiliated Hospital of Yangtze University, Jingzhou 434400, Hubei, People’s Republic of China

申请注册联系人邮政编码：

Applicant postcode：

 434000

研究负责人邮政编码：

Study leader's postcode：

 434000

申请人所在单位：

长江大学附属第一医院

Applicant's institution：

The First Affiliated Hospital of Yangtze University

研究负责人所在单位：

长江大学附属第一医院

Affiliation of the Leader：

The First Affiliated Hospital of Yangtze 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：

 K20200102

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：

荆州市第一人民医院医学伦理委员会

Name of the ethic committee：

Medical ethics committee of The First Affiliated Hospital of Yangtze University

伦理委员会批准日期：

Date of approved by ethic committee：

 2020-01-15 00:00:00

伦理委员会联系人：

徐澄

Contact Name of the ethic committee：

Chen Xu

伦理委员会联系地址：

中国湖北省荆州市沙市区航空路8号

Contact Address of the ethic committee：

The First Affiliated Hospital of Yangtze University, Jingzhou 434400, Hubei, People’s Republic of China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 1816313926

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：

长江大学附属第一医院

Primary sponsor：

The First Affiliated Hospital of Yangtze University

研究实施负责（组长）单位地址：

中国湖北省荆州市沙市区航空路8号

Primary sponsor's address：

The First Affiliated Hospital of Yangtze University, Jingzhou 434400, Hubei, People’s Republic of 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)：

荆州

Country：

China

Province：

Hubei

City：

Jingzhou

单位(医院)：

长江大学附属第一医院

具体地址：

中国湖北省荆州市沙市区航空路8号

Institution
hospital：

The First Affiliated Hospital of Yangtze University

Address：

8 Hangkong Road, Shashi District

经费或物资来源：

荆州市第一人民医院院内科研项目,湖北省自然科学基金项目 (2018CFB775).

Source(s) of funding：

Support by The First Affiliated Hospital of Yangtze University and Hubei Provincial Natural Science Foundation of China (2018CFB775).

研究疾病：

新型冠状病毒肺炎所致ARDS  

Target disease：

NCP-related ARDS

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：

队列研究 

Study design：

Cohort study 

研究目的：

根据柏林定义描述不同严重程度ARDS的住院NCP患者的临床特征。本研究报告的ARDS发病率和死亡率对于早期识别重度ARDS的个体具有相当大的价值，严重的ARDS患者，可能从进一步治疗中获益的患者。  

Objectives of Study：

The objective of this case series was to describe the clinical characteristics of hospitalized NCP patients that had different severity ARDS according to the Berlin definition. The baseline ARDS morbidity and mortality reported in this study will be of considerable value for the early identification of individuals who are at risk of developing severe ARDS and who are most likely to benefit from further treatment.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.回顾性分析2020年1月23日至3月6日期间发生ARDS的所有NCP患者的数据。
2.长江大学第一附属医院根据WHO暂行指南对NCP进行实验室确认，根据柏林定义进行ARDS诊断。
3.所有发生ARDS和接受机械通气的NCP患者的数据。
4.纳入病例均根据医学图表确诊为ARDS患者，连续两次动脉血气分析（ABGA），氧合指数（OI），动脉氧分压（PaO2）/吸入氧分数（FiO2）<300 mmHg（呼气末正压，PEEP≥5cm H2O），双侧放射学不透明在计算机断层扫描（CT）上，不能用渗出液、肺塌陷或结节来解释，也不能用心源性肺水肿来解释呼吸衰竭

Inclusion criteria

Laboratory confirmation of NCP was performed at The First Affiliated Hospital of Yangtze University according to WHO interim guidelines,10 while ARDS diagnosis was performed according to the Berlin definitions.
all NCP patients who developed ARDS and who received mechanical ventilation. Included cases were confirmed ARDS patients according to their medical charts, had two consecutive arterial blood gas analysis (ABGA) with oxygenation index (OI), partial pressure of arterial oxygen (PaO2)/fraction of inspired oxygen (FiO2) < 300 mmHg (with positive end-expiratory pressure, PEEP ≥ 5 cm H2O), had bilateral radiographic opacities on computed tomography (CT) that could not be explained by effusions, pulmonary collapse, or nodules, and had respiratory failure that could not be explained by cardiogenic pulmonary edema.

排除标准：

排除了脉搏血氧饱和度（SpO2）大于95%的病例
氧疗后脉搏血氧饱和度（SpO2）超过95%（以每分钟3升的流速）的患者被排除在研究之外。
氧合指数高于300 mmHg的患者也被排除在研究之外

Exclusion criteria：

cases were excluded as they sustained a pulse oxygen saturation (SpO2) more than 95%. Additionally, patients with pulse oxygen saturation (SpO2) of more than 95% after oxygen therapy ( at a flow rate of 3 liters per minute) were excluded from the study. Patients with oxygenation index higher than 300 mmHg were also excluded from the study.

研究实施时间：

Study execute time：

从 From 2020-02-01 00:00:00至 To 2020-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2013-01-23 00:00:00 至 To 2020-03-06 00:00:00

干预措施：

Interventions：

组别：

轻、中、重度ARDS

样本量：

 45

Group：

mild, moderate, severe ARDS

Sample size：

干预措施：

Nil

干预措施代码：

Intervention：

Nil

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)：

 荆州 

Country：

China

Province：

Hubei

City：

Jingzhou

单位(医院)：

 长江大学附属第一医院 

单位级别：

 三甲医院 

Institution
hospital：

The First Affiliated Hospital of Yangtze University

Level of the institution：

Tertiary A Hospital

测量指标：

Outcomes：

指标中文名：

氧分压

指标类型：

主要指标

Outcome：

partial pressure of arterial oxygen

Type：

Primary indicator

测量时间点：

诊断为ARDS 24小时内

测量方法：

呼吸机测量

Measure time point of outcome：

it was obtained within 24 hours of ARDS diagnosis

Measure method：

show on mechanical ventilation

采集人体标本：

Collecting sample(s)
from participants：

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 88 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）：

长江大学第一附属医院根据WHO暂行指南对NCP进行实验室确认，根据柏林定义进行ARDS诊断。我们的分析包括了所有发生ARDS和接受机械通气的NCP患者的数据。

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

Laboratory confirmation of NCP was performed at The First Affiliated Hospital of Yangtze University according to WHO interim guidelines,10 while ARDS diagnosis was performed according to the Berlin definitions.9The severity of the ARDS was determined based on the degree of hypoxemia as mild (200 mmHg < PF ratio

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：

Blinding：

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）：

支持本研究结果的数据可根据合理要求从通讯作者处获得。没有姓名和识别码的参与者数据将在相应作者和国家卫生委员会批准后提供。研究结果公布后，可根据要求将数据提供给其他人。一旦数据共享获得批准，将提供电子邮件地址用于通信。在评估相应作者和国家卫生委员会的数据共享请求时，需要一份详细说明研究目标和统计分析的提案。在此过程中，还可能需要额外的材料。

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

The data that support the findings of this study are available from the corresponding author upon reasonable request. Participant data without names and identifiers will be made availabl

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：

我们回顾了所有实验室确诊的NCP患者的电子病历。记录的数据包括人口统计信息、病史、暴露史、共病、症状、体征、实验室检查结果、胸部CT扫描、治疗和结果。在诊断ARDS的24小时内，获得了有关收缩压、呼吸频率、血常规、凝血、生化检查、胸部CT扫描、动脉血氧分压（PaO2）/吸入氧分压（FIO2）等临床资料。休克是根据世卫组织2019年新型冠状病毒病（COVID-19）指南定义的，而急性肾损伤是根据血清肌酐水平诊断的。如果血清超敏肌钙蛋白I（hsTNI）浓度高于参考范围的上限（34.2pg/mL），则诊断为心脏损伤。所有的临床数据都由一个经验丰富的医生团队进行审查。通过与相关医疗保健提供者和患者家属的直接沟通，收集并澄清任何缺失或不确定的记录。

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

We reviewed the electronic medical records of all patients with laboratory-confirmed NCP. Recorded data included demographic information, medical history, exposure history, comorbidities, symptoms, signs, laboratory findings, chest CT scans, treatments, and outcomes. The majority of clinical data regarding systolic pressure, respiratory rate, blood routine blood test, coagulation, biochemical tests, chest CT scans, as well as partial pressure of arterial oxygen (PaO2)/fraction of inspired oxygen (FIO2) were obtained within 24 hours of ARDS diagnosis. Shock was defined according to the guidelines of WHO for novel coronavirus disease 2019 (COVID-19), while acute kidney injury was diagnosed based on serum creatinine levels. Cardiac injury was diagnosed if the serum concentration of hypersensitive cardiac troponin I (hsTNI) was above the upper limit of the reference range (34.2 pg/mL). All clinical data were reviewed by an experienced team of physicians. Any missing or uncertain records were collected and clarified through direct communication with involved health-care providers and the families of the patients.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2020-04-11 23:02:18