ChiCTR2600122677 版本V1.0 版本创建时间2026/04/16 11:12:25 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:

ChiCTR2600122677 

最近更新日期:

Date of Last Refreshed on:

2026-04-16 11:12:20 

注册时间:

Date of Registration:

2026-04-16 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

基于胜任力导向教育的麻醉科住院医师危机资源管理能力分层培养模式构建研究

Public title:

Research on the Construction of a Competency-Based Hierarchical Training Model for Crisis Resource Management Skills of Anesthesiology Residents in Training

注册题目简写:

基于胜任力导向的麻醉住培医师危机资源管理能力分层培养模式构建研究

English Acronym:

Research on the Construction of a Competency-Based Hierarchical Training Model for Crisis Resource Management Skills of Anesthesiology Residents in Training

研究课题的正式科学名称:

基于胜任力导向教育的麻醉科住院医师危机资源管理能力分层培养模式构建研究

Scientific title:

Research on the Construction of a Competency-Based Hierarchical Training Model for Crisis Resource Management Skills of Anesthesiology Residents in Training

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:

蒋婧妍 

研究负责人:

蒋婧妍 

Applicant:

JiangJingyan 

Study leader:

Jiang Jingyan 

申请注册联系人电话:

Applicant telephone:

+86 574 87016852

研究负责人电话:

Study leader's
telephone:

+86 574 87016852

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:

rmjiangjingyan@nbu.edu.cn

研究负责人电子邮件:

Study leader's E-mail:

rmjiangjingyan@nbu.edu.cn

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:

浙江省宁波市鄞州区百丈东路251号

研究负责人通讯地址:

宁波市百丈东路251号

Applicant address:

No. 251, Baizhang East Road, Yinzhou District, Ningbo City, Zhejiang province

Study leader's address:

No. 251 Bai Zhang east road , Ningbo

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:

宁波大学附属人民医院

Applicant's institution:

People's Hospital affiliated to Ningbo University

研究负责人所在单位:

宁波大学附属人民医院

Affiliation of the Leader:

The affiliated people's hospital of Ningbo University

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:

宁大附人伦审2026研第052号

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:

宁波大学附属人民医院医学伦理委员会

Name of the ethic committee:

Medical Ethics Committee of Ningbo University Affiliated People's Hospital

伦理委员会批准日期:

Date of approved by ethic committee:

2026-04-13 00:00:00

伦理委员会联系人:

陈丹丹

Contact Name of the ethic committee:

Chen DanDan

伦理委员会联系地址:

宁波市百丈东路251号

Contact Address of the ethic committee:

No. 251 Bai Zhang east road , Ningbo

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 574 87017385

伦理委员会联系人邮箱:

Contact email of the ethic committee:

497274513@qq.com

研究实施负责(组长)单位:

宁波大学附属人民医院

Primary sponsor:

The affiliated people's hospital of Ningbo University

研究实施负责(组长)单位地址:

宁波市百丈东路251号

Primary sponsor's address:

No. 251 Bai Zhang east road , Ningbo

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

浙江省

市(区县):

Country:

China

Province:

Zhejiang

City:

单位(医院):

宁波大学附属人民医院

具体地址:

宁波市百丈东路251号

Institution
hospital:

The affiliated people's hospital of Ningbo University

Address:

No. 251 Bai Zhang east road , Ningbo

经费或物资来源:

宁波大学教学研究项目

Source(s) of funding:

Teaching and Research Project of Ningbo University

研究疾病:

无  

Target disease:

None

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:

队列研究 

Study design:

Cohort study 

研究目的:

通过本研究,将探索出一套标准明确、课程体系完善、评估科学的标准化培养范式,为实现住院医师临床胜任力的螺旋式上升提供坚实的实证依据,最终服务于围术期患者安全质量的整体提升。  

Objectives of Study:

Through this research, a standardized training model with clear standards, a complete curriculum system, and scientific assessment will be explored. This will provide solid empirical evidence for the spiral improvement of clinical competence of resident physicians, ultimately contributing to the overall enhancement of perioperative patient safety and quality.

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.取得执业医师资格或拟申请执业医师资格的全日制规培学员;

Inclusion criteria

1.Full-time standardized training trainees who have obtained or intend to apply for the physician qualification.

排除标准:

1.中途退培、休学超过 3 个月或无法全程参与教学考核的学员。为控制偏倚,两组学员在年龄、性别、初始学历及入学考试成绩等基线资料上将进行统计学均衡性检验,确保组间具有可比性。

Exclusion criteria:

1.The students who withdraw from the training midway, take a leave of absence for more than 3 months, or are unable to participate fully in the teaching assessments will be excluded. To control for bias, a statistical balance test will be conducted on baseline data such as age, gender, initial education level, and entrance exam scores between the two groups of students to ensure comparability.

研究实施时间:

Study execute time:

From 2026-01-22 00:00:00 To 2026-12-31 00:00:00  

征募观察对象时间:

Recruiting time:

From 2026-04-16 00:00:00 To 2026-10-31 00:00:00

干预措施:

Interventions:

组别:

观察组

样本量:

20

Group:

Observation 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):

浙江省 

市(区县):

 

Country:

China

Province:

Zhejiang

City:

单位(医院):

宁波大学附属人民医院 

单位级别:

三级甲等 

Institution
hospital:

The affiliated people's hospital of Ningbo University

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

规范化行为重塑

指标类型:

主要指标

Outcome:

Standardized Behavior Reshaping

Type:

Primary indicator

测量时间点:

案例全程

测量方法:

发现危机征兆时,能够准确发出求助信号并执行标准化的初步处理流程

Measure time point of outcome:

Full case process

Measure method:

When signs of crisis are detected, one can accurately send a distress signal and execute standardized initial response procedures.

指标中文名:

团队协作与资源管理

指标类型:

主要指标

Outcome:

Team Collaboration and Resource Management

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

领导力与复杂决策

指标类型:

主要指标

Outcome:

Leadership and Complex Decision-Making

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:

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 20 years
最大 Max age 35 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):

不共享

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

Not shared

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:

数据采集并记录

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

Data collection and recording

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2026-04-16 11:12:20