不同麻醉方式对75岁以上老年患者术后并发症的影响

注册号:

Registration number:

ChiCTR2200065094 

最近更新日期:

Date of Last Refreshed on:

2023-06-21 21:52:04 

注册时间:

Date of Registration:

2022-10-27 00:00:00 

注册号状态:

补注册

Registration Status:

Retrospective registration

注册题目:

不同麻醉方式对75岁以上老年患者术后并发症的影响

Public title:

Effects of different anesthesia methods on postoperative complications in elderly patients over 75 years old

注册题目简写:

English Acronym:

研究课题的正式科学名称:

不同麻醉方式对75岁以上老年患者术后并发症的影响

Scientific title:

Effects of different anesthesia methods on postoperative complications in elderly patients over 75 years old

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:

欧阳春磊 

研究负责人:

米卫东 

Applicant:

Chunlei Ouyang 

Study leader:

Weidong Mi 

申请注册联系人电话:

Applicant telephone:

+86 18810300815

研究负责人电话:

Study leader's
telephone:

+86 13381082966

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:

ouyangchunlei@gmail.com

研究负责人电子邮件:

Study leader's E-mail:

wwdd1962@aliyun.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:

北京市海淀区复兴路28号

研究负责人通讯地址:

北京市海淀区复兴路28号

Applicant address:

28 Fuxing Road, Haidian District, Beijing

Study leader's address:

28 Fuxing Road, Haidian District, Beijing

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:

解放军总医院

Applicant's institution:

Chinese PLA General Hospital

研究负责人所在单位:

解放军总医院

Affiliation of the Leader:

Chinese PLA General Hospital

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:

S2022-195-01

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:

中国人民解放军总医院医学伦理委员会

Name of the ethic committee:

Ethics Committee of Chinese PLA General Hospital

伦理委员会批准日期:

Date of approved by ethic committee:

2022-04-22 00:00:00

伦理委员会联系人:

曹江

Contact Name of the ethic committee:

Jiang Cao

伦理委员会联系地址:

北京市海淀区复兴路28号

Contact Address of the ethic committee:

28 Fuxing Road, Haidian District, Beijing

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 10 66937166

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:

解放军总医院

Primary sponsor:

Chinese PLA General Hospital

研究实施负责(组长)单位地址:

北京市海淀区复兴路28号

Primary sponsor's address:

28 Fuxing Road, Haidian District, Beijing

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):

海淀

Country:

China

Province:

Beijing

City:

Haidian

单位(医院):

解放军总医院

具体地址:

北京市海淀区复兴路28号

Institution
hospital:

Chinese PLA General Hospital

Address:

28 Fuxing Road, Haidian District, Beijing

经费或物资来源:

国家级科研课题《老年患者围手术期管理综合技术方案的研究》

Source(s) of funding:

National scientific research project

研究疾病:

术后并发症  

Target disease:

Postoperative complications

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:

病例研究 

Study design:

Case study 

研究目的:

研究不同麻醉方式对75岁以上老年患者术后并发症的影响  

Objectives of Study:

To study effects of different anesthesia methods on postoperative complications in elderly patients over 75 years old

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. 临床资料缺失;
2. ASA分级5级。

Exclusion criteria:

1. Lack of clinical data;
2. ASA level V.

研究实施时间:

Study execute time:

From 2022-04-01 00:00:00 To 2022-12-01 00:00:00  

征募观察对象时间:

Recruiting time:

From 2022-04-01 00:00:00 To 2022-05-31 00:00:00

干预措施:

Interventions:

组别:

全身麻醉组

样本量:

0

Group:

General anesthesia group

Sample size:

干预措施:

干预措施代码:

Intervention:

N/A

Intervention code:

组别:

非全身麻醉组

样本量:

0

Group:

Non general anesthesia group

Sample size:

干预措施:

干预措施代码:

Intervention:

N/A

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(区县):

海淀 

Country:

China

Province:

Beijing

City:

Haidian

单位(医院):

解放军总医院 

单位级别:

三甲 

Institution
hospital:

Chinese PLA General Hospital

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

术后并发症

指标类型:

主要指标

Outcome:

Postoperative complications

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

麻醉方法

指标类型:

主要指标

Outcome:

Anesthesia method

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

既往史

指标类型:

主要指标

Outcome:

Personal history

Type:

Primary 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

指标类型:

主要指标

Outcome:

Routine blood test

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

BMI

指标类型:

主要指标

Outcome:

BMI

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:

征募研究对象情况:

Recruiting status:

结束

/Completed

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):

none

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法:

Blinding:

none

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):

https://pan.baidu.com/s/1AVuPAnwaXSG6su-zXd5KeQ

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

https://pan.baidu.com/s/1AVuPAnwaXSG6su-zXd5KeQ

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:

电子采集

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

electric collection

数据与安全监察委员会:

Data and Safety Monitoring Committee:

无/No

注册人:

Name of Registration:

 2022-10-27 17:44:12