今天是:2020-09-28 星期一

高压氧治疗新型冠状病毒肺炎(COVID-19)的有效性和安全性研究
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注册号:

Registration number:

ChiCTR2000032011 

最近更新日期:

Date of Last Refreshed on:

2020-04-17 

注册时间:

Date of Registration:

2020-04-17 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

高压氧治疗新型冠状病毒肺炎(COVID-19)的有效性和安全性研究 

Public title:

Effecacy and Safety of Hyperbaric Oxygen Therapy to patients with novel coronavirus pneumonia (COVID-19) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

高压氧治疗新型冠状病毒肺炎(COVID-19)的有效性和安全性研究 

Scientific title:

Effecacy and Safety of Hyperbaric Oxygen Therapy to patients with novel coronavirus pneumonia (COVID-19) 

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:

郭大志 

研究负责人:

潘树义 

Applicant:

Dazhi Guo 

Study leader:

Shuyi Pan 

申请注册联系人电话:

Applicant telephone:

+86 18600317342 

研究负责人电话:

Study leader's telephone:

+86 18600310183 

申请注册联系人传真 :

Applicant Fax:

+86 010 66957586 

研究负责人传真:

Study leader's fax:

+86 010 66957586 

申请注册联系人电子邮件:

Applicant E-mail:

guodazhigod1983@163.com 

研究负责人电子邮件:

Study leader's E-mail:

psy9992011@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:

北京市海淀区阜成路6号 

研究负责人通讯地址:

北京市海淀区阜成路6号 

Applicant address:

6 Fucheng Road, Haidian District, Beijing, China 

Study leader's address:

6 Fucheng Road, Haidian District, Beijing, 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:

中国人民解放军总医院第六医学中心 

Applicant's institution:

Sixth Medical Center of PLA General 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:

HSSLL018 

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:

武汉火神山医院伦理委员会 

Name of the ethic committee:

Wuhan Huoshenshan Hospital Medical Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-03-18 

伦理委员会联系人:

郭玉峰 

Contact Name of the ethic committee:

Yufeng Guo 

伦理委员会联系地址:

湖北省武汉市火神山医院 

Contact Address of the ethic committee:

Wuhan Huoshenshan Hospital, Zhi-Yin-Hu Avenue, Caidian District, Wuhan, Hubei, 050035, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 18629593177 

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:

中国人民解放军总医院第六医学中心 

Primary sponsor:

Sixth Medical Center of PLA General Hospital 

研究实施负责(组长)单位地址:

北京市海淀区阜成路6号 

Primary sponsor's address:

6 Fucheng Road, Haidian District, Beijing, 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):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中国人民解放军总医院第六医学中心

具体地址:

北京市海淀区阜成路6号

Institution
hospital:

Sixth Medical Center of PLA General Hospital

Address:

6 Fucheng Road, Haidian District

国家:

中国

省(直辖市):

湖北省

市(区县):

武汉市

Country:

China

Province:

Hubei Province

City:

Wuhan City

单位(医院):

武汉火神山医院

具体地址:

湖北省武汉市火神山医院,050035

Institution
hospital:

Wuhan Huoshenshan Hospital

Address:

Zhi-Yin-Hu Avenue, Caidian District

经费或物资来源:

后勤科研课题 

Source(s) of funding:

Logistics research Project 

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:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

通过高压氧治疗纠治缺氧患者组织缺氧,纠正继发病理生理损害,促进病人恢复。 

Objectives of Study:

To correct tissue hypoxia and secondary pathophysiological damage in patients with COVID-2019 by hyperbaric oxygen therapy, and promote patient's recovery.  

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、年龄大于18岁; 2、疑似新冠病毒肺炎患者同时具备以下病原学或血清学证据之一者: (1)实时荧光RT-PCR检测新型冠状病毒核酸阳性; (2)病毒基因测序,与已知的新型冠状病毒高度同源; (3)血清新型冠状病毒特异性IgM抗体和IgG抗体阳性;血清新型冠状病毒特异性IgG抗体由阴性转为阳性或恢复期较急性期4倍及以上升高。 3、普通型患者具有发热、呼吸道等症状,影像学可见肺炎表现。 4、重症患者符合下列任何一条: (1)出现气促,RR330次/分; (2)静息状态下,指氧饱和度≤93%; (3)动脉血氧分压(PaO2)/吸氧浓度(Fi02)≤300mmHg (1mmHg=O. 133kPa); (4)肺部影像学显示24-48小时内病灶明显进展>50%者按重型管理。 5、无高压氧治疗禁忌症。 6、患者本人和家属能够签署知情同意书。 

Inclusion criteria

1. Aged >=18 years old; 2. Patients suspected of having COVID-2019 pneumonia who also have one of the following etiological or serological evidence: (1) Real-time fluorescent RT-PCR detection of COVID-2019 nucleic acid positive; (2) viral gene sequencing, and Known novel coronaviruses are highly homologous; (3) Serum novel coronavirus-specific IgM antibodies and IgG antibodies are positive; serum novel coronavirus-specific IgG antibodies change from negative to positive or the recovery period is 4 times higher than the acute period and increased high; 3. Ordinary patients have fever, respiratory tract and other symptoms, and imaging shows pneumonia; 4. Severe patients meet any of the following criterias: (1) Shortness of breath, RR330 times / min; (2) At rest, refers to oxygen saturation <=93%; (3) Arterial blood oxygen partial pressure (PaO2) / aspiration Oxygen concentration (Fi02) <=300 mmHg (1 mmHg = 0.133 kPa); (4) Pulmonary imaging showed that the lesions significantly progressed within 24-48 hours> 50% were managed as heavy. 5. No contraindications to hyperbaric oxygen therapy; 6. The patient and his family can sign the informed consent. 

排除标准:

(1)妊娠或哺乳期妇女; (2)有肝、肾、内分泌、血液等重大疾病史; (3)有凝血功能异常; (4)有明确的肿瘤病史; (6)有营养状况不良,恶液质病史;(7)合并高压氧治疗禁忌症,如气胸、咽鼓管调压不良、内出血等;(8)危重型新冠肺炎患者; 

Exclusion criteria:

1. pregnancy or lactation; 2. having a history of major diseases such as disorders of liver, kidney, endocrine or hematological systems; 3. coagulation disorder; 4. explicit history of tumors; 5. having a history of malnutrition and cachexia; 6. contraindicated by HBOT, such as pneumothorax, poor pressure adjustment of the eustachian tube, and internal hemorrhage; 7. Critically ill patients. 

研究实施时间:

Study execute time:

From2020-04-17To 2020-05-17 

征募观察对象时间:

Recruiting time:

From2020-04-17To 2020-05-10 

干预措施:

Interventions:

组别:

1.5ATA

样本量:

15

Group:

1.5ATA

Sample size:

干预措施:

1.5ATA 高压氧

干预措施代码:

Intervention:

1.5ATA HBO

Intervention code:

组别:

2.5ATA

样本量:

15

Group:

2.5ATA

Sample size:

干预措施:

2.5ATA 高压氧

干预措施代码:

Intervention:

2.5ATA HBO

Intervention code:

组别:

对照组

样本量:

15

Group:

Control group

Sample size:

干预措施:

Routine treatment

干预措施代码:

Intervention:

Routine treatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖北省 

市(区县):

武汉市 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

火神山医院 

单位级别:

 

Institution
hospital:

Huoshenshan Hospital  

Level of the institution:

 

测量指标:

Outcomes:

指标中文名:

氧合指数

指标类型:

主要指标 

Outcome:

Oxygenation index

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

活动耐力

指标类型:

次要指标 

Outcome:

Activity endurance

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

IL-6水平

指标类型:

次要指标 

Outcome:

IL-6 level

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血常规生化指标

指标类型:

次要指标 

Outcome:

Blood routine biochemical indicators

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CT

指标类型:

次要指标 

Outcome:

LUNG CT scan

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

微颗粒

指标类型:

次要指标 

Outcome:

microparticle

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

C反应蛋白

指标类型:

次要指标 

Outcome:

CRP

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:

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 18 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):

研究人员采用随机数字表将患者随机分为三组,分别为对照组,1.5ATA高压氧组,2.5ATA高压氧组。

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

The researchers used a random number table to randomly divide the patients into three groups, namely the control group, the 1.5ATA hyperbaric oxygen group, and the 2.5ATA hyperbaric oxygen group.

盲法:

Not stated

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):

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

pubmed,https://pubmed.ncbi.nlm.nih.gov/

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

pubmed,https://pubmed.ncbi.nlm.nih.gov/

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(Case Record Form, CRF)和电子采集和管理系统(Electronic Data Capture, EDC)

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

Case Record Form (CRF) and Electronic Data Capture (EDC)

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-04-17
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