Today is 2019-12-08

Epidemiology, diagnosis and treatment of perioperative severe allergic reactions in China
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注册号:

Registration number:

ChiCTR1900025956 

最近更新日期:

Date of Last Refreshed on:

2019-09-15 

注册时间:

Date of Registration:

2019-09-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

全国围术期严重过敏反应流行病学及诊治现状调查 

Public title:

Epidemiology, diagnosis and treatment of perioperative severe allergic reactions in China 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

全国围术期严重过敏反应流行病学及诊治现状调查 

Scientific title:

Epidemiology, diagnosis and treatment of perioperative severe allergic reactions in China 

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:

宫瑞松 

研究负责人:

赵晶 

Applicant:

Gong Ruisong 

Study leader:

Zhao Jing 

申请注册联系人电话:

Applicant telephone:

+86 18811155832 

研究负责人电话:

Study leader's telephone:

+86 13901048114 

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:

gongruisongjnu@163.com 

研究负责人电子邮件:

Study leader's E-mail:

zhaojing1009@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:

北京市朝阳区樱花东街2号中日友好医院手术麻醉科 

研究负责人通讯地址:

北京市朝阳区樱花东街2号中日友好医院手术麻醉科 

Applicant address:

2 East Yinghua Road, Chaoyang District, Beijing, China 

Study leader's address:

2 East Yinghua Road, Chaoyang 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:

中日友好医院 

Applicant's institution:

China-Japan Friendship 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:

2019-108-K76 

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:

中日友好医院临床研究伦理委员会 

Name of the ethic committee:

China-Japan Friendship Hospital Clinical Research Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-08-30 

伦理委员会联系人:

陈燕芬 

Contact Name of the ethic committee:

Chen Yanfen 

伦理委员会联系地址:

北京市朝阳区樱花东街2号中日友好医院 

Contact Address of the ethic committee:

China-Japan Friendship Hospital, 2 East Yinghua Road, 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:

中日友好医院 

Primary sponsor:

China-Japan Friendship Hospital 

研究实施负责(组长)单位地址:

北京市朝阳区樱花东街2号 

Primary sponsor's address:

2 East Yinghua Road, 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(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中日友好医院

具体地址:

北京市朝阳区樱花东街2号

Institution
hospital:

China-Japan Friendship Hospital

Address:

2 East Yinghua Road, Chaoyang District, Beijing

经费或物资来源:

国家医疗数据中心框架体系建设和综合评价应用试点项目 

Source(s) of funding:

National Medical Data Center Framework System Construction and Comprehensive Evaluation Application Pilot Project 

研究疾病:

围术期严重过敏反应 

Target disease:

perioperative severe allergic reactions 

研究疾病代码:

 

Target disease code:

 

研究类型:

流行病学研究 

Study type:

Epidemilogical research 

研究所处阶段:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

完成全国围术期严重过敏反应流行病学调查,建立中国围术期过敏反应数据库: ①收集我国围术期过敏反应患者流行病学数据,如总体发生率、各地区发生率、死亡率、就医百分比等,分析我国围术期过敏反应流行病学特点; ②了解疑似围手术期过敏反应患者被转诊、调查的比例,其诊治过程与指南相符程度如何; ③了解救治过程中使用的药物,如肾上腺素、α受体激动剂、血管加压素等,以及严重过敏患者的预后; ④收集我国不同地区围术期严重过敏反应患者的临床医疗安全数据,发现临床救治围术期过敏反应过程中存在的医疗质量安全问题。 

Objectives of Study:

To complete the national investigation on the epidemiology of perioperative severe allergic reactions and establish the Chinese perioperative allergic reactions database: ①To collect epidemiological data of perioperative allergic reactions in China, such as the overall incidence rate, incidence rate by region, mortality rate, and percentage of medical treatment in China, and analyze the epidemiological characteristics of perioperative allergic reactions in China; ②To find out the proportion of patients with suspected perioperative allergic reactions being referred and investigated, and how the diagnosis and treatment process is consistent with the guidelines; ③To find out the medications used in the treatment, such as adrenaline, alpha receptor agonists, vasopressin, etc., as well as the prognosis of patients with severe allergies; ④To collect clinical safety data of patients with perioperative severe allergic reactions in different regions of China, and find out the medical quality and safety problems in the treatment of perioperative allergic reactions. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

1、符合可疑围术期严重过敏反应病例初筛标准,且事件发生于2018年9月1日至2019年8月31日之间。 2、所有成人和儿科病例均为在入选医院进行全身麻醉、监护下镇静、局麻或神经阻滞、椎管内麻醉或镇痛,产科病例包括分娩镇痛。 

Inclusion criteria

1. The patient met the initial screening criteria for suspected perioperative severe anaphylaxis and the incident occurred between September 1, 2018 and August 31, 2019; 2. All adult and pediatric cases were performed under general anesthesia, monitored anesthesia care, local anesthesia or nerve block, spinal anesthesia or analgesia in the selected hospital. Obstetric cases included labor analgesia. 

排除标准:

1、病历资料不完整或明显错误,无法用于病例分析。 2、由非麻醉医师提供的镇静或局部麻醉的病例,重症监护中的常规镇静。 

Exclusion criteria:

1. The medical records are incomplete or obviously incorrect and cannot be used for case analysis; 2. Cases of sedation or local anesthesia weren't provided by anesthesiologists, routine sedation in intensive unit care. 

研究实施时间:

Study execute time:

From2019-10-01To 2019-12-31 

干预措施:

Interventions:

组别:

Case series

样本量:

1000000

Group:

Case series

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):

北京市 

市(区县):

朝阳区 

Country:

China 

Province:

Beijing 

City:

Chaoyang District 

单位(医院):

中日友好医院 

单位级别:

三级甲等 

Institution
hospital:

China-Japan Friendship Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

围术期严重过敏反应

指标类型:

主要指标 

Outcome:

perioperative severe allergic reactions

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:

尚未开始

Not yet recruiting

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):

连续入组

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

N/A

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Within six months after the trial complete

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):

http://47.93.47.51:9999/; ResMan

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

http://47.93.47.51:9999/; ResMan

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:

Case Record Form

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-09-15
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