ChiCTR2600122603 版本V1.0 版本创建时间2026/04/15 16:59:43 中国临床试验注册中心

审核状态:

Project audit state:

通过审核

Successful

注册号:

Registration number:

ChiCTR2600122603 

最近更新日期:

Date of Last Refreshed on:

2026-04-15 16:59:38 

注册时间:

Date of Registration:

2026-04-15 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

血管活性药物堆积性冲击风险调查

Public title:

Investigation of Cumulative Shock Risk Associated with Vasoactive Drug Administration

注册题目简写:

English Acronym:

研究课题的正式科学名称:

血管活性药物堆积性冲击风险调查

Scientific title:

Investigation of Cumulative Shock Risk Associated with Vasoactive Drug Administration

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:

李瑛园 

研究负责人:

李瑛园 

Applicant:

Li Yingyuan 

Study leader:

Li Yingyuan 

申请注册联系人电话:

Applicant telephone:

+86 18845099380

研究负责人电话:

Study leader's
telephone:

+86 20 86832256

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:

liyingyuan0608@163.com

研究负责人电子邮件:

Study leader's E-mail:

liyingyuan0608@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:

中国广东省广州市花都区新华街新华路48号

研究负责人通讯地址:

中国广东省广州市花都区新华街新华路48号

Applicant address:

48 Xinhua Street, Xinhua District, Guangzhou, Guangdong, China

Study leader's address:

48 Xinhua Street, Xinhua District, Guangzhou, Guangdong, 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:

广州市花都区人民医院

Applicant's institution:

Guangzhou Huadu District People's Hospital

研究负责人所在单位:

广州市花都区人民医院

Affiliation of the Leader:

Huadu District Peoples Hospital of Guangzhou

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:

批件(2026)-0073

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:

广州市花都区人民医院临床试验伦理委员会

Name of the ethic committee:

Clinical Trial Ethics Committee of Guangzhou Huadu District People's Hospital

伦理委员会批准日期:

Date of approved by ethic committee:

2026-03-27 00:00:00

伦理委员会联系人:

张晓尉

Contact Name of the ethic committee:

Zhang Xiaowei

伦理委员会联系地址:

中国广东省广州市花都区新华街新华路48号

Contact Address of the ethic committee:

48 Xinhua Street, Xinhua District, Guangzhou, Guangdong, China

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 20 62935296

伦理委员会联系人邮箱:

Contact email of the ethic committee:

20xwzhang1@alumni.stu.edu.cn

研究实施负责(组长)单位:

广州市花都区人民医院

Primary sponsor:

Huadu District Peoples Hospital of Guangzhou

研究实施负责(组长)单位地址:

中国广东省广州市花都区新华街新华路48号

Primary sponsor's address:

48 Xinhua Street, Xinhua District, Guangzhou, Guangdong, 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):

广东

市(区县):

Country:

China

Province:

Guangdong

City:

单位(医院):

广州市花都区人民医院

具体地址:

中国广东省广州市花都区新华街新华路48号

Institution
hospital:

Huadu District Peoples Hospital of Guangzhou

Address:

48 Xinhua Street, Xinhua District, Guangzhou, Guangdong, China

经费或物资来源:

自筹

Source(s) of funding:

Self-funded

研究疾病:

手术室和重症监护室患者血管活性药物堆积性冲击现象  

Target disease:

Accumulation-induced vasopressor surge phenomenon in operating room and intensive care unit patients

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:

横断面 

Study design:

Cross-sectional 

研究目的:

旨在了解医务人员对血管活性药物堆积性冲击风险事件的认知现状。  

Objectives of Study:

Aimed at understanding healthcare professionals' current awareness of the risk of accumulation-related surge events from vasoactive drugs.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

1.临床麻醉医生和重症医学医生; 2.自愿参加

Inclusion criteria

1.Clinical anesthesiologist and critical care physician; 2.Voluntary participation

排除标准:

1.非相关专业人员; 2.明显重复填写问卷者; 3.关键题目缺失严重或回答明显不合理者

Exclusion criteria:

1.non-specialists; 2.Clearly duplicate questionnaire respondent; 3.Those with serious omissions of key questions or whose answers are clearly unreasonable

研究实施时间:

Study execute time:

From 2026-01-01 00:00:00 To 2026-07-31 00:00:00  

征募观察对象时间:

Recruiting time:

From 2026-04-20 00:00:00 To 2026-07-31 00:00:00

干预措施:

Interventions:

组别:

观察组

样本量:

300

Group:

Observational group

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):

广东 

市(区县):

 

Country:

China

Province:

Guangdong

City:

单位(医院):

广州市花都区人民医院 

单位级别:

三级甲等 

Institution
hospital:

Huadu District Peoples Hospital of Guangzhou

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

医务人员对堆积性冲击风险的认知分布

指标类型:

主要指标

Outcome:

Healthcare professionals' awareness of cumulative stress injury risk

Type:

Primary indicator

测量时间点:

测量方法:

问卷调查

Measure time point of outcome:

Measure method:

Questionnaire survey

指标中文名:

医务人员应对策略现状

指标类型:

主要指标

Outcome:

Current status of healthcare professionals' coping strategies

Type:

Primary indicator

测量时间点:

测量方法:

问卷调查

Measure time point of outcome:

Measure method:

Questionnaire survey

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

NA

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 NA years
最大 Max age NA 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

否No

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):

去标识化的个体参与者数据、研究方案等可在研究发表后,通过向通讯作者提交合理研究提案获取。

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

De-identified individual participant data, study protocols, and similar materials will be available after publication of the research upon submission of a reasonable research proposal to the corresponding author.

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:

在线问卷工具

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

Online survey tool

数据与安全监察委员会:

Data and Safety Monitoring Committee:

无/No

注册人:

Name of Registration:

 2026-04-15 16:59:38