ChiCTR2500105325 版本V1.0 版本创建时间2025/07/02 08:33:13 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：

 ChiCTR2500105325 

最近更新日期：

Date of Last Refreshed on：

 2025-07-02 08:33:08 

注册时间：

Date of Registration：

 2025-07-02 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

基于儿科TEE模拟器训练对TEE技能提高的有效性研究

Public title：

Can simulation-based training on pediatric TEE simulator improve pediatric TEE skills?

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于儿科TEE模拟器训练对TEE技能提高的有效性研究

Scientific title：

Can simulation-based training on pediatric TEE simulator improve pediatric TEE skills?

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：

徐颖怡 

研究负责人：

徐颖怡 

Applicant：

Yingyi Xu 

Study leader：

Yingyi Xu 

申请注册联系人电话：

Applicant telephone：

 +86 136 3232 4394

研究负责人电话：

Study leader's
telephone：

+86 136 3232 4394

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：

 513438980@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 513438980@qq.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：

广东省广州市越秀区人民中路318号

研究负责人通讯地址：

广东省广州市越秀区人民中路318号

Applicant address：

318 Middle Renmin Road, Yuexiu District, Guangzhou, Guangdong, China

Study leader's address：

318 Middle Renmin Road, Yuexiu 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：

广州市妇女儿童医疗中心

Applicant's institution：

Guangzhou Women and Children’s Medical Center

研究负责人所在单位：

广州市妇女儿童医疗中心

Affiliation of the Leader：

Guangzhou Women and Children’s Medical Center

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：

 穗妇儿 科伦 批字[2022]第273A01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：

广州市妇女儿童医疗中心科研伦理委员会

Name of the ethic committee：

Guangzhou Women and Children's Medical Center Institutional Review Board

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-02-13 00:00:00

伦理委员会联系人：

李庆丰

Contact Name of the ethic committee：

Qingfeng Li

伦理委员会联系地址：

广州市金穗路9号

Contact Address of the ethic committee：

9 Jinsui Road, Tianhe District, Guangzhou, Guangdong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 20 3836 7270

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：

广州市妇女儿童医疗中心

Primary sponsor：

Guangzhou Women and Children's Medical Center

研究实施负责（组长）单位地址：

广东省广州市越秀区人民中路318号

Primary sponsor's address：

318 Middle Renmin Road, Yuexiu 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)：

广州市

Country：

China

Province：

Guangdong

City：

Guangzhou

单位(医院)：

广州市妇女儿童医疗中心

具体地址：

金穗路9号

Institution
hospital：

Guangzhou Women and Children's Medical Center

Address：

9 Jinsui Road, Tianhe District

经费或物资来源：

无

Source(s) of funding：

None

研究疾病：

无  

Target disease：

None

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

自2017年以来，中国体外循环学会(CHSECC)每年对18岁以下先天性心脏病(CHD)患者接受心脏手术的数据进行调查。虽然与前一年相比减少了16,433人，但未成年人冠心病患者总数仍为37,665人，其中高达60.1%的人在2020年完成了心脏手术[1-3]。经食道超声心动图(TEE)不仅在心脏手术的指导和评估中起着关键作用，而且能显著降低死亡率和发病率[4]。目前，儿科心脏麻醉师必须熟练掌握TEE技术，在围手术期正确解读TEE图像。在手术室进行TEE教学是传统的TEE学习方法[5]。但手术室是一个高压力环境，当受训人员执行TEE时，可能会给患者带来风险[6-7] ——特别是在儿科患者中。模拟医学教育可以作为一种可供选择的教学方法，它可以提高患者的安全性，而且比传统的教学培训更有效[7-8]。TEE模拟器复杂且昂贵，有必要以尽可能好的方式使用它们。因此，学员在TEE模拟器上练习直到达到预定的熟练程度的掌握学习可以确保每个学员在临床实践之前都做好了准备。为了实现掌握学习，我们需要一个基于模拟的测试，它可以告诉我们受训人员何时达到了所需的熟练程度。然而，这项测试并不存在，我们不知道学员在被允许在手术室执行程序之前需要在TEE模拟器上练习多长时间。开发一种基于模拟的测试，可以测量麻醉医生操作儿童TEE的能力。最重要的是，我们试图弄清楚，在临床中儿科TEE模拟器上进行基于模拟的培训是否会提高儿科TEE技能。  

Objectives of Study：

From 1990 to 2017, the incidence of congenital heart disease in children increased by 18.7%. According to Pediatric Cardiac Care Consortium (PCCC) data from 1982 to 2007, as many as 500 surgeries were performed each year. Since 2017, the Chinese Society of Extracorporeal Circulation (ChSECC) has surveyed the date about patients with congenital heart disease (CHD) who accepted cardiac surgery under the age of 18 annually. Although a decrease of 16,433 compared to the previous year, the total number of minors with CHD still was 37,665 and up to 60.1% of them completed cardiac surgery reported in 2020. Transesophageal Echocardiography (TEE) not only plays a key role in the guidance and evaluation of cardiac surgery, but also significantly reduces mortality and morbidity. Currently, it is important for pediatric cardiac anesthesiologists to be competent in TEE techniques and correctly interpret TEE images during perioperative period. TEE teaching in the operating room (OR) is the traditional method of learning TEE. But the OR is a high stress environment that can introduce risk to the patient when a trainee performs TEE - particularly in pediatric patients. Simulation-based medical education could be used as an alternative teaching method.?It could improve both patients’ safety and be more effective than traditional teaching training. TEE simulators are complicated and expensive and it is necessary to use them in the best possible way. So, mastery learning where trainees practice on the TEE simulator until they reach a pre-defined proficiency level could ensure that every trainee is ready before clinical practice. To implement mastery learning we need a simulation-based test that can tell us when our trainees have reached the desired level of proficiency. However, this test does not exist and we don’t know how much time trainees need to practice on the TEE simulator before being allowed to perform procedures in the OR. Develop a simulation-based test that can measure competence in pediatric TEE. Above all, we try to figure out whether simulation-based training on pediatric TEE simulator improve pediatric TEE skills in the clinical world.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

患儿纳入标准：(1)足月儿； (2)年龄为1岁-6岁拟行ASA I-III级择期手术患儿； 学员纳入标准：(1)1-3级住院医师培训生; (2)之前从未接受过心脏超声心动图培训和心脏麻醉轮转的住院医师，最初通过电子邮件自愿受邀参与研究。

Inclusion criteria

Inclusion criteria for children: (1) full-term infants; (2) children aged 1-6 years of age who were proposed for elective ASA class I-III surgery; Inclusion criteria for trainees: (1)grade 1-3 residency trainees; (2)previously experienced echocardiography training androtations in cardiac anesthesia, and residents were initially invited to participate in the study by email.

排除标准：

患儿排除标准： 1、术前有咳嗽、流涕或发热等呼吸道感染症状； 2、WBC＞12*10^9/L或CRP＞8.5mg/L等炎性指标升高； 3、Apgar评分小于9分； 4、有凝血功能障碍等禁忌； 5、有相关循环、呼吸系统疾病不能配合； 6、患儿家属无法理解及同意知情同意内容 学员排除标准：在最初的辅导后经上级医生评估不符合资质或课程时间安排上有冲突的学员

Exclusion criteria：

Exclusion criteria: 1, Preoperative symptoms of respiratory tract infection such as cough, runny nose or fever; 2, Elevated inflammatory indicators such as WBC>12*10^9/L or CRP>8.5mg/L; 3, Apgar score less than 9; 4, Contraindications such as coagulation dysfunction; 5, Related circulatory and respiratory diseases can not cooperate; 6, Family members of the child can not understand and agree to the content of the informed consent. Participants exclusion criteria: After the initial tutorial due to any difficulties

研究实施时间：

Study execute time：

从 From 2022-10-30 00:00:00至 To 2025-10-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-07-02 00:00:00 至 To 2025-10-30 00:00:00

干预措施：

Interventions：

组别：

干预组

样本量：

 22

Group：

Intervention group

Sample size：

干预措施：

采用基于人体模型的TEE模拟器进行一对一教学。干预组还将接受三期临床教学:第一期观看:观看教师在临床世界中操作儿科TEE;第2期指导:学员在指导老师的讲解和指导下，在实际患者身上进行TEE操作;第三阶段:行动:学员在实际患者中单独操作，没有教练的解释和指导。

干预措施代码：

Intervention：

The Intervention group received a one-on-one teaching session using the mannequin-based TEE simulator. Intervention Group will also receive three periods of teaching clinical: Period 1 WATCH: Watch the instructor operate the pediatrics TEE in the clinical world; Period 2 GUIDE: Trainees take the operation of TEE in the actual patient under the explanation and guidance of the instructor; Period 3:ACTION: Trainees operate alone in the actual patient without the explanation and guidance of the instructor.

Intervention code：

组别：

对照组

样本量：

 22

Group：

Control groups

Sample size：

干预措施：

在实际手术过程中，在手术室进行一对一教学。对照组进行三期临床教学:第一期观看:观看教师播放儿科学TEE模拟器;第二阶段指导:学员在指导老师的讲解和指导下进行TEE操作;第三阶段:行动:学员单独操作，没有教练的解释和指导。

干预措施代码：

Intervention：

The Control group had a one-on-one teaching session in the operating theatre during actual operations. Control group will receive three periods of teaching in clinical: Period 1 WATCH: Watch the instructor play the pediatrics TEE simulator; Period 2 GUIDE: Trainees take the operation of TEE under the explanation and guidance of the instructor; Period 3:ACTION: Trainees operate alone without the explanation and guidance of the instructor.

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)：

 广州 

Country：

China

Province：

Guangdong

City：

GuangZhou

单位(医院)：

 广州市妇女儿童医疗中心 

单位级别：

 三甲 

Institution
hospital：

Guangzhou Women and Children Medical Center

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

11个TEE标准切面的评分

指标类型：

主要指标

Outcome：

11 Basic views in practical examination with anatomic structures scored

Type：

Primary indicator

测量时间点：

完成11个切面操作后由2名经验丰富的TEE导师根据Ferrero评分量表打分

测量方法：

使用Ferrero等人在以往调查中成功应用的评分量表进行评估。该评估工具包含11个基本TEE视图。每个切面都有一个明确的标准，范围从0到10分，包括：成像角度，总体清晰度，以及与每个切面相关的3个主要解剖结构的可视化。所有分数均由2名经验丰富的TEE导师打分。

Measure time point of outcome：

Scored by 2 experienced TEE instructors on a Ferrero rating scale after completion of the11 basic TEE views

Measure method：

A grading scale applied successfully by Ferrero et al [11] in previous investigations was used for the evaluations. This assessment tool contains 11 basic TEE views. Each view has a defined criterion that ranges from 0-10 points, including: imaging angle, overall clarity, and visualization of the 3 major anatomical structures associated with each view. All scores were scored by 2 experienced TEE instructors.

指标中文名：

考试分数

指标类型：

次要指标

Outcome：

Exam score

Type：

Secondary indicator

测量时间点：

测量方法：

在完成每个阶段的训练后，每位住院医师将以问卷形式参加理论选择题考试

Measure time point of outcome：

Measure method：

Upon completion of each phase of training, each resident will take a multiple choice theory exam in the form of a questionnaire

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

None

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 岁 years
最大 Max age 岁 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）：

在每个住院医生完成注册后，他们会得到一个唯一的号码，这个号码是研究员邱倩琪医生通过随机化过程随机生成的。此识别号码用于随机化程序和数据收集表格。根据随机号码将住院医师随机分为干预组和对照组。

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

After each resident completes registration, they are given a unique number, which is randomly generated through a randomization process. This identification number is used for randomization procedures and data collection forms. Before the start of the experiment, Statistician QiuQianqi randomly generate random assignment sequences according to a random procedure.Afterwards anesthesiology residents randomized to intervention and control groups.

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：

评分表由2名经验丰富的TEE导师分别打分。受训者、讲师、计分员和数据分析师不知道具体分配组以实现双盲试验。

Blinding：

All scores were scored by 2 experienced TEE instructors. Trainees, instructors, scorers, and data analysts were unaware of treatment assignment groups.

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）：

原始数据采集使用CRF表，管理系统为EDC系统。只有此研究相关人员才能登陆系统收集和记录数据。

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

The original data were collected using the CRF form and the management system was the EDC system.Only the personnel involved in this research can log in to collect and record the date.

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：

采集使用CRF表，管理系统为EDC系统。只有此研究相关人员才能登陆收集和记录。

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

CRF table was used for collection, and the management system was EDC system. Only those involved in the study can log in to collect and record.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-07-02 08:33:08