ChiCTR2500097130 版本V1.0 版本创建时间2025/02/13 09:06:34 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：

ChiCTR2500097130 

最近更新日期：

Date of Last Refreshed on：

2025-02-13 09:06:26 

注册时间：

Date of Registration：

2025-02-13 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

X线通用人工智能对于全身骨骼及重要脏器疾病辅助诊断的RCT研究

Public title：

Randomized controlled trial on X-ray general artificial intelligence for assisting diagnosis of bone and important organ diseases

注册题目简写：

English Acronym：

研究课题的正式科学名称：

X线通用人工智能对于全身骨骼及重要脏器疾病辅助诊断的RCT研究

Scientific title：

Randomized controlled trial on X-ray general artificial intelligence for assisting diagnosis of bone and important organ diseases

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：

梅炯 

研究负责人：

梅炯 

Applicant：

Jiong Mei 

Study leader：

Jiong Mei 

申请注册联系人电话：

Applicant telephone：

+86 139 0187 0631

研究负责人电话：

Study leader's telephone：

+86 139 0187 0631

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：

meijiong@sjtu.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

meijiong@sjtu.edu.cn

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

贵州航天医院

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：

贵州省遵义市汇川区大连路825号

研究负责人通讯地址：

贵州省遵义市汇川区大连路825号

Applicant address：

No. 825 Dalian Road, Huichuan District, Zunyi City, Guizhou Province

Study leader's address：

No. 825 Dalian Road, Huichuan District, Zunyi City, Guizhou Province

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：

贵州航天医院

Applicant's institution：

Guizhou Aerospace Hospital

研究负责人所在单位：

贵州航天医院

Affiliation of the Leader：

Guizhou Aerospace Hospital

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

{2025}KY-02

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：

贵州航天医院 医学伦理审查委员会

Name of the ethic committee：

Medical Ethics Review Committee of Guizhou Aerospace Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2025-01-02 00:00:00

伦理委员会联系人：

陈明勇

Contact Name of the ethic committee：

Mingyong Chen

伦理委员会联系地址：

贵州省遵义市汇川区大连路825号

Contact Address of the ethic committee：

No. 825 Dalian Road, Huichuan District, Zunyi City, Guizhou Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 137 0851 3360

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：

贵州航天医院

Primary sponsor：

Guizhou Aerospace Hospital

研究实施负责（组长）单位地址：

贵州省遵义市汇川区大连路825号

Primary sponsor's address：

No. 825 Dalian Road, Huichuan District, Zunyi City, Guizhou Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

贵州

市(区县)：

Country：

China

Province：

Guizhou

City：

单位(医院)：

贵州航天医院

具体地址：

贵州省遵义市汇川区大连路825号

Institution
hospital：

Guizhou Aerospace Hospital

Address：

No. 825 Dalian Road, Huichuan District, Zunyi City, Guizhou Province

经费或物资来源：

国家重点研发计划子课题：跨域资源的异构计算融合（2022YFB4501702） 国家自然科学基金面上项目：基于深度学习的全身各部骨折诊断编码标准化研究（62376159）

Source(s) of funding：

Subtopic of National Key Research and Development Program: Heterogeneous Computing Fusion of Cross Domain Resources (2022YFB4501702) National Natural Science Foundation of China General Project: Standardization of Diagnosis Coding for Fractures Based on Deep Learning (62376159)

Target disease：

Fractures in all parts of the body, pneumonia, and intestinal obstruction

Target disease code：

研究类型：

诊断试验

Study type：

Diagnostic test

研究所处阶段：

 I期+II期 

Study phase：

1-2

研究设计：

诊断试验诊断准确性 

Study design：

Diagnostic test for accuracy 

研究目的：

采用RCT评估Xreport辅助诊断给骨折、肺炎、肠梗阻患者带来的临床获益。  

Objectives of Study：

Using RCT to evaluate the clinical benefits of Xreport assisted diagnosis for patients with fractures, pneumonia, and intestinal obstruction.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

纳入标准： 1.年龄：18-75岁； 2.本研究纳入疑似骨折、肺炎、肠梗阻，需要接受X线影像检查的患者， 骨折患者纳入标准为具备下述2项中任何１项：1） 有外伤史，患处剧烈疼痛，活动受限；2） 有肢体畸形、异常活动、骨擦音中任意一项； 肺炎患者纳入标准参照社区获得性肺炎诊断标准，具备下述４项中任何１项均可纳入：1） 新近出现或原有呼吸道症状加重；2） 发热；3） 肺实变体征和（或）湿性啰音；4） 外周血白细计数＞10×10^9／Ｌ或 ＜４×10^9／Ｌ，伴或不伴核左移； 肠梗阻患者纳入标准为具备下述3项中任何１项：1） 腹痛、腹胀、恶心、呕吐、肛门无力、排便停止，可有腹部手术史或腹部炎症史；2） 体格检查提示不同程度的腹胀或肠蠕动波和肠型的存在；腹壁柔软，有或无轻微压痛；3） 腹部叩诊有高音调的金属肠音或类似于空气吹过水面时产生的声音； 3.签署知情同意书，理解并且同意依从该研究的要求和试验流程安排。

Inclusion criteria

Inclusion criteria: 1. Age: 18-75 years old. 2.This study included patients suspected of having fractures, pneumonia, or intestinal obstruction who required X-ray imaging examination, The inclusion criteria for fracture patients are those who have any one of the following two conditions: 1) a history of trauma, severe pain in the affected area, and limited mobility; 2) Any of limb deformities, abnormal activity, or bone fricatives; The inclusion criteria for pneumonia patients refer to the diagnostic criteria for community-acquired pneumonia, and any one of the following four conditions can be included: 1) newly appeared or aggravated respiratory symptoms; 2) Fever; 3) Signs of lung consolidation and/or wet rales; 4) Peripheral blood white matter count>10 × 10 ^ 9/L or<4 × 10 ^ 9/L, with or without left nuclear shift; The inclusion criteria for patients with intestinal obstruction are any one of the following three conditions: 1) abdominal pain, bloating, nausea, vomiting, anal weakness, cessation of bowel movements, and a history of abdominal surgery or inflammation; 2) Physical examination suggests the presence of varying degrees of bloating, intestinal peristalsis waves, and intestinal types; Soft abdominal wall with or without slight tenderness; 3) High pitched metallic intestinal sounds or sounds similar to those produced when air blows over water during abdominal percussion; 3.Sign the informed consent form, understand and agree to comply with the requirements and experimental procedures of the study.

排除标准：

1.生命体征不稳定的患者； 2.无自主意识的患者； 3.怀疑同时患有骨折、肺炎、肠梗阻中两者或全部。

Exclusion criteria：

1. Patients with unstable vital signs. 2. Unconscious patients. 3. Suspect having both or all of fractures, pneumonia, and intestinal obstruction at the same time.

研究实施时间：

Study execute time：

从 From 2025-03-01 00:00:00至 To 2025-06-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-03-01 00:00:00 至 To 2025-06-01 00:00:00  

诊断试验：

Diagnostic Tests：

金标准或参考标准（即可准确诊断某疾病的单项方法或多项联合方法，在本研究中用于诊断是否有该病的临床参考标准）：

确诊骨折的金标准为具备下述①②项中任何１项和第③项：① 有外伤史，患处剧烈疼痛，活动受限；② 有肢体畸形、异常活动、骨擦音中任意一项；③CT影像出现骨皮质断裂、骨骼透亮线影、骨皮质压缩扭曲、游离骨片或碎裂骨块中任意一个征象； 确诊肺炎的金标准为具备下述①②③④项中任何１项并伴有第⑤项：① 新近出现或原有呼吸道症状加重；② 发热；③ 肺实变体征和（或）湿性啰音；④ 外周血白细计数＞10×10^9／Ｌ或 ＜４×10^9／Ｌ，伴或不伴核左移；⑤CT显示新出现片状、斑片状浸润性阴影或间质性 改变伴或不伴胸腔积液?； 确诊肠梗阻的金标准为：具备下述①②③项中任何１项及第④项：① 腹痛、腹胀、恶心、呕吐、肛门无力、排便停止，可有腹部手术史或腹部炎症史；② 体格检查提示不同程度的腹胀或肠蠕动波和肠型的存在；腹壁柔软，有或无轻微压痛；③ 腹部叩诊有高音调的金属肠音或类似于空气吹过水面时产生的声音；④CT显示肠管扩张、肠壁增厚、肠腔变窄、肠管充气。 以上三种疾病确诊阴性的标准为影像报告无阳性发现，且两位急诊科医生均同意阴性诊断。如其中任何一位医生持不同看法，则患者接受CT检查，结果仍为阴性，且24小时内病情无进展，可确诊阴性。

Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):

The gold standard for diagnosing a fracture is having any one of the following: ① a history of trauma, severe pain in the affected area, and limited mobility; ② Any one of limb deformities, abnormal activity, or bone fricative sounds; ③ CT images show any of the following signs: cortical fracture, bone transparency line shadow, cortical compression distortion, free bone slice or fragmented bone block; The gold standard for diagnosing pneumonia is to have any one of the following conditions (1), (2), (3), (4), accompanied by condition (5): (1) recent onset or worsening of pre-existing respiratory symptoms; (2) Fever; ③ Signs of lung consolidation and/or wet rales; ④ Peripheral blood white matter count>10 × 10 ^ 9/L or<4 × 10 ^ 9/L, with or without left nuclear shift; ⑤ CT shows new patchy or patchy infiltrative shadows or interstitial changes with or without pleural effusion; The gold standard for diagnosing intestinal obstruction is: having any one of the following conditions: ① abdominal pain, bloating, nausea, vomiting, anal weakness, cessation of bowel movements, and a history of abdominal surgery or inflammation; ② Physical examination suggests the presence of varying degrees of bloating, intestinal peristalsis waves, and intestinal types; Soft abdominal wall with or without slight tenderness; ③ High pitched metallic intestinal sounds or sounds similar to those produced when air blows over water during abdominal percussion; ④ CT shows dilation of the intestinal tract, thickening of the intestinal wall, narrowing of the intestinal lumen, and inflation of the intestinal tract. The criteria for a negative diagnosis of the above three diseases are that there are no positive findings in the imaging report, and both emergency department doctors agree to a negative diagnosis. If any of the doctors hold a different opinion, the patient will undergo CT examination and the result will still be negative. If there is no progress in the condition within 24 hours, the diagnosis can be negative.

指标试验（即本研究的待评估诊断试验，无论为方法、生物标志物或设备，均请列出名称）：

骨折/肺炎/肠梗阻诊断的灵敏度、特异度、准确率；疑似骨折患者：是否确诊骨折、骨折休克率、30天患者死亡率、重症监护室入住率、脓毒血症率；疑似肺炎患者：是否确诊肺炎、30天患者死亡率、重症监护室入住率、呼吸机或气管插管使用率、脓毒血症率、重症肺炎率；疑似肠梗阻患者：是否确诊肠梗阻、30天患者死亡率、重症监护室入住率、脓毒血症率。

Index test:

Sensitivity, specificity, and accuracy of diagnosis for fractures/pneumonia/intestinal obstruction; Suspected fracture patients: whether the fracture has been diagnosed, fracture shock rate, 30 day patient mortality rate, intensive care unit occupancy rate, sepsis rate; Suspected pneumonia patients: whether diagnosed with pneumonia, 30 day mortality rate, ICU occupancy rate, ventilator or tracheal intubation usage rate, sepsis rate, severe pneumonia rate; Suspected intestinal obstruction patients: whether diagnosed with intestinal obstruction, 30 day mortality rate, ICU occupancy rate, sepsis rate.

目标人群（可以是某种疾病患者或正常人群，详细描述其疾病特征，注意应纳入符合分布特点的全序列病例，具有良好的代表性）

本研究纳入疑似骨折、肺炎、肠梗阻，需要接受X线影像检查的患者， 疑似骨折患者纳入标准为具备下述2项中任何１项：① 有外伤史，患处剧烈疼痛，活动受限；② 有肢体畸形、异常活动、骨擦音中任意一项； 疑似肺炎患者纳入标准参照社区获得性肺炎诊断标准，具备下述４项中任何１项均可纳入：① 新近出现或原有呼吸道症状加重；② 发热；③ 肺实变体征和（或）湿性啰音；④ 外周血白细计数＞10×10^9／Ｌ或 ＜４×10^9／Ｌ，伴或不伴核左移； 疑似肠梗阻患者纳入标准为具备下述3项中任何１项：① 腹痛、腹胀、恶心、呕吐、肛门无力、排便停止，可有腹部手术史或腹部炎症史；② 体格检查提示不同程度的腹胀或肠蠕动波和肠型的存在；腹壁柔软，有或无轻微压痛；③ 腹部叩诊有高音调的金属肠音或类似于空气吹过水面时产生的声音；

例数:

Sample size:

10780

Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):

This study included patients suspected of having fractures, pneumonia, or intestinal obstruction who required X-ray imaging examination, The inclusion criteria for suspected fracture patients are those who have any one of the following two conditions: ① a history of trauma, severe pain in the affected area, and limited mobility; ② Any of limb deformities, abnormal activity, or bone fricatives; The inclusion criteria for suspected pneumonia patients refer to the diagnostic criteria for community-acquired pneumonia, and any one of the following four conditions can be included: ① newly appeared or aggravated respiratory symptoms; ② Fever; ③ Signs of lung consolidation and/or wet rales; ④ Peripheral blood white matter count>10 × 10 ^ 9/L or<4 × 10 ^ 9/L, with or without left nuclear shift; The inclusion criteria for suspected intestinal obstruction patients are any one of the following three conditions: ① abdominal pain, bloating, nausea, vomiting, anal weakness, cessation of bowel movements, and a history of abdominal surgery or inflammation; ② Physical examination suggests the presence of varying degrees of bloating, intestinal peristalsis waves, and intestinal types; Soft abdominal wall with or without slight tenderness; ③ High pitched metallic intestinal sounds or sounds similar to those produced when air blows over water during abdominal percussion;

容易混淆的疾病人群（即与目标疾病不易区分的一种或多种不同疾病，应避免采用正常人群对照的病例-对照设计）：

无

例数:

Sample size:

0

Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:

NA

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 贵州 

市(区县)：

 遵义 

Country：

China 

Province：

Guizhou 

City：

 

单位(医院)：

贵州航天医院 

单位级别：

三甲 

Institution
hospital：

Guizhou Aerospace Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

灵敏度

指标类型：

主要指标

Outcome：

sensitivity

Type：

Primary indicator

测量时间点：

患者急诊就诊30天后

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

特异度

指标类型：

次要指标

Outcome：

specificity

Type：

Secondary indicator

测量时间点：

患者急诊就诊30天后

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

准确率

指标类型：

次要指标

Outcome：

accuracy

Type：

Secondary indicator

测量时间点：

患者急诊就诊30天后

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

受试者工作特性曲线下面积

指标类型：

次要指标

Outcome：

area under the curve, AUC

Type：

Secondary indicator

测量时间点：

患者急诊就诊30天后

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

30天患者死亡率

指标类型：

次要指标

Outcome：

mortality rate in 30 days

Type：

Secondary indicator

测量时间点：

患者急诊就诊30天后

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

重症监护室入住率

指标类型：

次要指标

Outcome：

ICU rate

Type：

Secondary indicator

测量时间点：

患者急诊就诊30天后

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

脓毒血症率

指标类型：

次要指标

Outcome：

sepsis rate

Type：

Secondary indicator

测量时间点：

患者急诊就诊30天后

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

休克率

指标类型：

次要指标

Outcome：

shock rate

Type：

Secondary indicator

测量时间点：

患者急诊就诊30天后

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

重症肺炎率

指标类型：

次要指标

Outcome：

severe pneumonia rate

Type：

Secondary indicator

测量时间点：

患者急诊就诊30天后

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

呼吸机或气管插管使用率

指标类型：

次要指标

Outcome：

usage rate of ventilator or tracheal intubation

Type：

Secondary indicator

测量时间点：

患者急诊就诊30天后

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：

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 18 岁 years
最大 Max age 75 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）：

运用分层随机法，按照病种分层。急诊接诊医生在判断患者符合“疑似骨折/肺炎/肠梗阻，需要接受X线影像检查”条件，并取得患者知情同意后，通知研究人员有新入组患者。研究人员立即使用excel中的RAND函数随机生成1个0-1之间的小数。若小于0.5则，分入相应疾病的对照组；大于等于0.5则分入相应疾病的实验组。急诊接诊医生无法得知分组情况。

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

Use stratified randomization method to stratify according to disease types. After determining that the patient meets the criteria of "suspected fracture/pneumonia/intestinal obstruction, requiring X-ray imaging examination" and obtaining the patient's informed consent, the emergency attending physician notifies the researchers of new enrolled patients. The researchers immediately used the RAND function in Excel to randomly generate a decimal between 0-1. If it is less than 0.5, it will be assigned to the control group for the corresponding disease; If it is greater than or equal to 0.5, it will be divided into the experimental group of the corresponding disease. The emergency attending physician is unable to determine the grouping status.

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：

双盲，施盲对象为患者和急诊接诊医生。两者均只能看到影像报告，无法获知该报告出具时放射科医生是否使用Xreport辅助诊断。

Blinding：

Double blind. Both the patient and the emergency attending physician can only see the imaging report and cannot know whether the radiologist used Xreport to assist in diagnosis when the report was issued.

是否共享原始数据：

IPD sharing

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）：

2025年12月后，邮箱方式。meijiong@sjtu.edu.cn

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

After December through email. meijiong@sjtu.edu.cn

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：

放射学报告及DICOM序列号对应关系导出为病历记录表；DICOM存储在移动存储设备上

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

Export the correspondence between radiology reports and DICOM serial numbers as a medical record table; DICOM is stored on mobile storage devices

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-02-13 09:06:26