老年患者围手术期肺损伤危险因素的研究

注册号:

Registration number:

ChiCTR1900028651 

最近更新日期:

Date of Last Refreshed on:

2019-12-29 22:30:12 

注册时间:

Date of Registration:

2019-12-29 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

老年患者围手术期肺损伤危险因素的研究

Public title:

Study on the risk factors of perioperative lung injury in elderly patients

注册题目简写:

English Acronym:

研究课题的正式科学名称:

老年患者围手术期肺损伤危险因素的研究

Scientific title:

Study on the risk factors of perioperative lung injury in elderly 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:

武庆平 

研究负责人:

武庆平 

Applicant:

Qingping Wu 

Study leader:

Qingping Wu 

申请注册联系人电话:

Applicant telephone:

+86 13971605283

研究负责人电话:

Study leader's
telephone:

+86 13971605283

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:

wqp1968@163.com

研究负责人电子邮件:

Study leader's E-mail:

wqp1968@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:

湖北省武汉市江汉区解放大道1277号

研究负责人通讯地址:

湖北省武汉市江汉区解放大道1277号

Applicant address:

1277 Jiefang Road, Jianghan District, Wuhan, Hubei, China

Study leader's address:

1277 Jiefang Road, Jianghan District, Wuhan, Hubei, 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:

华中科技大学同济医学院附属协和医院

Applicant's institution:

Huazhong University of Science & Technology

研究负责人所在单位:

华中科技大学同济医学院附属协和医院

Affiliation of the Leader:

Huazhong University of Science & Technology

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

S1254

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:

华中科技大学同济医学院医学伦理委员会

Name of the ethic committee:

Ethics Committee of Tongji Medical College of Huazhong University of Science and Technology

伦理委员会批准日期:

Date of approved by ethic committee:

2019-12-18 00:00:00

伦理委员会联系人:

陈汇

Contact Name of the ethic committee:

Hui Chen

伦理委员会联系地址:

湖北省武汉市航空路13号同济医学院基础医学院二号教学楼16楼12号办公室

Contact Address of the ethic committee:

Room 12, 16th Floor, 2nd Teaching Building, Basic Medical College, Tongji Medical College, 13 Hangkong Road, Wuhan, Hubei, 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:

华中科技大学同济医学院附属协和医院

Primary sponsor:

Union Hospital, Tongji Medical College, Huazhong University of Science & Technology

研究实施负责(组长)单位地址:

湖北省武汉市江汉区解放大道1277号

Primary sponsor's address:

1277 Jiefang Road, Jianghan 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):

华中科技大学同济医学院附属协和医院

具体地址:

江汉区解放大道1277号

Institution
hospital:

Union Hospital, Tongji Medical College, Huazhong University of Science & Technology

Address:

1277 Jiefang Road, Jianghan District

经费或物资来源:

国家重点专项计划

Source(s) of funding:

National key special plan

研究疾病:

肺损伤  

Target disease:

lung injury

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:

其它 

Study phase:

N/A

研究设计:

连续入组 

Study design:

Sequential 

研究目的:

1、研究老年患者围手术期肺损伤发生率; 2、研究老年患者围手术期肺损伤相关危险因素。  

Objectives of Study:

1. To study the incidence of perioperative lung injury in elderly patients; 2. To study the risk factors related to perioperative lung injury in elderly patients.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

Inclusion criteria

排除标准:

1、患者因疾患因素无法完成相应评估;
2、不愿意配合的患者;
3、难以随访的患者。

Exclusion criteria:

1. Patients are unable to complete the corresponding evaluation due to disease factors;
2. Patients who are unwilling to cooperate;
3. Patients who are difficult to follow up.

研究实施时间:

Study execute time:

From 2020-01-01 00:00:00 To 2022-12-31 00:00:00  

征募观察对象时间:

Recruiting time:

From 2020-01-12 00:00:00 To 2022-12-31 00:00:00

干预措施:

Interventions:

组别:

Case Series

样本量:

1000

Group:

Case Series

Sample size:

干预措施:

干预措施代码:

Intervention:

none

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):

华中科技大学同济医学院附属协和医院 

单位级别:

三甲医院 

Institution
hospital:

Union Hospital, Tongji Medical College, Huazhong University of Science & Technology

Level of the institution:

Tertiary A

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 

单位级别:

三甲医院 

Institution
hospital:

Chinese PLA General Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China

Province:

Beijing

City:

单位(医院):

中日友好医院 

单位级别:

三甲医院 

Institution
hospital:

China-Japan Friendship Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

浙江 

市(区县):

 

Country:

China

Province:

Zhejiang

City:

单位(医院):

浙江大学 

单位级别:

三甲医院 

Institution
hospital:

Zhejiang University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

湖北 

市(区县):

 

Country:

China

Province:

Hubei

City:

单位(医院):

十堰市太和医院 

单位级别:

三甲医院 

Institution
hospital:

Shiyan Taihe Hospita

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

湖北 

市(区县):

 

Country:

China

Province:

Hubei

City:

单位(医院):

武汉市中心医院 

单位级别:

三甲医院 

Institution
hospital:

Wuhan Central Hospital

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

肺损伤危险因素

指标类型:

主要指标

Outcome:

risk factors of lung injury

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:

组织:

Sample Name:

N/A

Tissue:

人体标本去向

其它  

说明

Fate of sample:

0thers  

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 65 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

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:

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):

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):

中国临床试验中心等网络平台,时间为试验结束半年内

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

China clinical trial center and other network platforms, within half a year after the end of the trial

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:

病例报告表(CRF)由研究者及时填写,以保证内容准确,总结及时,每个入选病例必须完成CRF。

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

Case report form (CRF) should be completed by the investigator in time to ensure the accuracy of the content and timely summary. CRF must be completed for each enrolled case.

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:

 2019-12-29 22:30:12