今天是:2020-03-30 星期一

丁琳医师:该研究的伦理审批文件未上传,请尽快上传。 俯卧位联合经鼻高流量或无创机械通气在中重度ARDS患者中有效性及安全性的前瞻性多中心队列研究
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注册号:

Registration number:

ChiCTR1900023564 

最近更新日期:

Date of Last Refreshed on:

2019-06-02 

注册时间:

Date of Registration:

2019-06-02 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

丁琳医师:该研究的伦理审批文件未上传,请尽快上传。 俯卧位联合经鼻高流量或无创机械通气在中重度ARDS患者中有效性及安全性的前瞻性多中心队列研究 

Public title:

Efficacy and safety of early prone positioning combined with HFNC or NIV in moderate to severe ARDS: a pilot Multi-center prospective cohort study 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

俯卧位联合经鼻高流量或无创机械通气在中重度ARDS患者中有效性及安全性的前瞻性多中心队列研究 

Scientific title:

Efficacy and safety of early prone positioning combined with HFNC or NIV in moderate to severe ARDS: a pilot Multi-center prospective cohort 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:

丁琳 

研究负责人:

贺航咏 

Applicant:

Ding Lin 

Study leader:

He Hang-Yong 

申请注册联系人电话:

Applicant telephone:

+86 15810471620 

研究负责人电话:

Study leader's telephone:

+86 13693585722 

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:

dinglin20080302@sina.com 

研究负责人电子邮件:

Study leader's E-mail:

yonghang2004@sina.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:

北京朝阳区工人体育场南里8号 

研究负责人通讯地址:

北京朝阳区工人体育场南里8号 

Applicant address:

8 Worker Stadium Road South, Chaoyang District, Beijing, China 

Study leader's address:

8 Worker Stadium Road South, Chaoyang District, Beijing, China 

申请注册联系人邮政编码:

Applicant postcode:

100020 

研究负责人邮政编码:

Study leader's postcode:

100020 

申请人所在单位:

首都医科大学附属北京朝阳医院 

Applicant's institution:

Beijing Institute of Respiratory Medicine, Beijing Chao-Yang 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:

CY2018-018 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

首都医科大学附属北京朝阳医院伦理委员会 

Name of the ethic committee:

The Ethics Committee of Chaoyang Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

顾佳 

Contact Name of the ethic committee:

Gu Jia 

伦理委员会联系地址:

北京朝阳区工人体育场南里8号首都医科大学附属北京朝阳医院伦理委员会 

Contact Address of the ethic committee:

The Ethics Committee of Chaoyang Hospital, 8 Worker Stadium Road South, Chaoyang District, Beijing, 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:

首都医科大学附属北京朝阳医院 

Primary sponsor:

Beijing Chao-Yang Hospital affiliated to Capital Medical University 

研究实施负责(组长)单位地址:

北京朝阳区工人体育场南里8号 

Primary sponsor's address:

8 Worker Stadium Road South, Chaoyang 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

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

首都医科大学附属北京朝阳医院

具体地址:

朝阳区工人体育场南里8号

Institution
hospital:

Institute of Respiratory Medicine, Beijing Chao-Yang Hospital

Address:

8 Worker Stadium Road South, Chaoyang District

经费或物资来源:

朝阳新星1351项目 

Source(s) of funding:

This study is supported by a grant from Chao-Yang Novel Star of 1351 Program 

研究疾病:

ARDS 

Target disease:

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:

探索性研究/预试验 

Study phase:

研究目的:

本研究的目的为观察早期应用俯卧位联合经鼻高流量或无创正压通气是否能降低中重度ARDS患者的气管插管率及安全性。 

Objectives of Study:

The aim of the study was to determine whether the early use of prone positioning (PP) combined with non-invasive ventilation (NIV) or high-flow nasal cannula (HFNC) can avoid the need for intubation in moderate to severe ARDS patients. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

During January 2018 to April 2019, ARDS patients admitted to the two respiratory intensive care unit (ICU) in two hospitals were first evaluated with a PEEP of 5 cmH2O supported by NIV for half an hour. And patients were included when their PFR were less than 200mmHg. It is up to the clinician to choose HFNC or NIV first. If the patient was supported with HFNC at first, once whose SpO2 less than 90% with a flow of 60L/min and FiO2 more than 80%, the patient was put into a prone position. If the SpO2 still could not maintain more than 90%, the patient was supported with NIV or NIV combined with PP. If the patient was supported with NIV at first, once the SpO2 still could not maintain more than 90%, the patient was supported with NIV+PP.  

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

纳入标准:

ARDS诊断需符合柏林定义:(1)存在急性呼吸衰竭。(2)发病7天以内,或者7天内新出现或呼吸道症状加重。(3)胸片或CT提示双侧渗出影,不能完全通过胸腔积液、肺不张或结节影解释。(4)心功能不全不是导致急性呼吸衰竭的主要原因。但患者符合上述标准,且氧和指数低于200mmHg时纳入研究。 

Inclusion criteria

The diagnosis of ARDS was made when a patient met the Berlin definition criteria: (1) presence of acute hypoxemic respiratory failure; (2) onset within 7days of insult, or new (within 7days) or worsening respiratory symptoms; (3) bilateral opacities on chest x-ray or CT not fully explained by effusions, lobar or lung collapse, or nodules; and (4) cardiac failure not the primary cause of acute respiratory failure.patients were included when their PFR were less than 200mmHg. 

排除标准:

(1)患者拒绝参与该研究。(2)患者不能配合治疗。 

Exclusion criteria:

(1) The patients who do not agree to participate in the research. (2) The patients who can not cooperate with treatment. 

研究实施时间:

Study execute time:

From2019-09-01To 2020-09-01 

干预措施:

Interventions:

组别:

1

样本量:

25

Group:

1

Sample size:

干预措施:

经鼻高流量

干预措施代码:

Intervention:

HFNC

Intervention code:

组别:

2

样本量:

25

Group:

2

Sample size:

干预措施:

无创正压通气

干预措施代码:

Intervention:

NIV

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京市 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京呼吸病研究所,北京朝阳医院 

单位级别:

三级甲等医院 

Institution
hospital:

Beijing Institute of Respiratory Medicine, Beijing Chao-Yang Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

氧和指数

指标类型:

主要指标 

Outcome:

PaO2/FiO2

Type:

Primary 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 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):

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

none

盲法:

N/A

Blinding:

N/A

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):

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

no

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:

 2019-06-02
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