中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2400090960
最近更新日期： Date of Last Refreshed on：	2024-10-16 16:58:36
注册时间： Date of Registration：	2024-10-16 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	成人重症肺炎进展为ARDS预测模型的构建与验证及临床应用与示范
Public title：	Construction and validation of prediction model for ARDS in adults with severe pneumonia and its clinical application and demonstration
注册题目简写：	成人重症肺炎进展为ARDS预测模型的构建与验证及临床应用与示范
English Acronym：	Construction and validation of prediction model for ARDS in adults with severe pneumonia and its clinical application and demonstration
研究课题的正式科学名称：	成人重症肺炎进展为ARDS预测模型的构建与验证及临床应用与示范
Scientific title：	Construction and validation of prediction model for ARDS in adults with severe pneumonia and its clinical application and demonstration
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：	贾贵阳	研究负责人：	贾贵阳
Applicant：	Guiyang Jia	Study leader：	Guiyang Jia
申请注册联系人电话： Applicant telephone：	+86 182 7560 9510	研究负责人电话： Study leader's telephone：	+86 182 7560 9510
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：	jiaguiyang@zmu.edu.cn	研究负责人电子邮件： Study leader's E-mail：	jiaguiyang@zmu.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：	遵义市红花岗区新龙大道与新蒲大道交汇处	研究负责人通讯地址：	遵义市红花岗区新龙大道与新蒲大道交汇处
Applicant address：	Intersection of Xinlong Avenue and Xinpu Avenue, Honghuagang District, Zunyi City	Study leader's address：	Intersection of Xinlong Avenue and Xinpu Avenue, Honghuagang District, Zunyi City
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：	遵义医科大学第二附属医院
Applicant's institution：	The Second Affiliated Hospital of Zunyi Medical University
研究负责人所在单位：	遵义医科大学第二附属医院
Affiliation of the Leader：	The Second Affiliated Hospital of Zunyi Medical University

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：	KYLL-2024-025	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：	遵义医科大学第二附属医院医学伦理审查委员会
Name of the ethic committee：	Medical Ethics Review Committee of the Second Affiliated Hospital of Zunyi Medical University
伦理委员会批准日期： Date of approved by ethic committee：	2024-04-15 00:00:00
伦理委员会联系人：	巩亮
Contact Name of the ethic committee：	Liang Gong
伦理委员会联系地址：	遵义市红花岗区新龙大道与新蒲大道交汇处
Contact Address of the ethic committee：	Intersection of Xinlong Avenue and Xinpu Avenue, Honghuagang District, Zunyi City
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 135 0852 1194	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：

遵义医科大学第二附属医院

Primary sponsor：

The Second Affiliated Hospital of Zunyi Medical University

研究实施负责（组长）单位地址：

遵义市红花岗区新龙大道与新蒲大道交汇处

Primary sponsor's address：

Intersection of Xinlong Avenue and Xinpu Avenue, Honghuagang District, Zunyi City

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	贵州省	市(区县)：	遵义市
Country：	china	Province：	guizhou	City：	zunyi
单位(医院)：	遵义医科大学第二附属医院	具体地址：	遵义市红花岗区新龙大道与新蒲大道交汇处
Institution hospital：	The Second Affiliated Hospital of Zunyi Medical University	Address：	Intersection of Xinlong Avenue and Xinpu Avenue, Honghuagang District, Zunyi City

经费或物资来源：

贵州省科技厅

Source(s) of funding：

Science and Technology Department of Guizhou Province

研究疾病：

重症肺炎

Target disease：

Severe pneumonia

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：

诊断试验新技术临床试验

Study phase：

Diagnostic New Technique Clincal Study

研究设计：

诊断性病例对照试验

Study design：

Diagnostic test: case-control

研究目的：

构建重症肺炎进展为ARDS的预测模型、并绘制概率列线图，早期识别 ARDS 的高危人群并计算 ARDS 的发生概率，及时采取有效干预措施，避免重症肺炎进展为 ARDS，提高重症肺炎的救治成功率。

Objectives of Study：

The prediction model of severe pneumonia progressing to ARDS was constructed, and the probability nomogram was drawn to identify high-risk groups of ARDS early and calculate the probability of ARDS occurrence, and effective intervention measures were taken in time to avoid severe pneumonia progressing to ARDS and improve the success rate of treatment of severe pneumonia

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

CAP inclusion criteria: Meet the 2007 Infectious Diseases Society of America/American Thoracic Society (ATS/ IDSA) Consensus Guidelines for CAP management in adults: Main criteria: 1. Invasive mechanical ventilation; 
2. Septic shock requiring vasopressors; 
Secondary criteria: 1. respiratory rate ≥30 times/min; 
2.PaO2/FiO2 ≤250mmHg; 
3. Multiple lung lobe infiltration; 
4. Blurred consciousness or disorientation; 
5. uremia (blood urea nitrogen level ≥20mg/dl); 
6. leukopenia (white blood cell count <4×10^9/L);
 7. thrombocytopenia (platelet count <100×10^9/L);
 8. low body temperature (core temperature < 36℃); 
9. Hypotension requiring active fluid resuscitation; Severe CAP can be diagnosed if one of the two primary criteria or three of the nine secondary criteria are met.
Inclusion criteria for HAP: HAP met the clinical diagnostic criteria recommended by the 2016 IDSA/ATS guidelines, that is, the presence of new or progressive infiltrating shadow on imaging 48 hours after admission, plus at least two of the following three abnormal manifestations :1. Fever (T > 38℃); 2. leukocyte increase > 12×10^9/L or decrease < 4×10^9/L; 3. Purulent airway secretions; According to the Chinese Guidelines for the Diagnosis and Treatment of hospital-acquired pneumonia and ventilator-associated Pneumonia (2018 edition), it is considered that :1. Mechanical ventilation therapy with tracheal intubation is required; 2. Septic shock that still requires vasoactive drug therapy after active fluid resuscitation; Those who meet either of these criteria are diagnosed with severe HAP.

排除标准：

CAP排除标准：1、患者在 CAP 发病前已确诊有严重呼吸功能障碍，如 ARDS、急性呼吸衰竭、严重肺水肿等； 2、多次（＞2 次）因肺炎入院或气管切开后需长期氧疗； 3、住院期间由其他科室转至综合 ICU 或呼吸内科； 4、入院时合并其他危险因素； 5、住院时间<24h； 6、临床资料不完善； 7、年龄＜18岁或≥80岁 HAP排除标准：1、入院时存在肺炎或处于潜伏期，人院小于 48 h 发生的肺炎； 2、患者在入院时合并其他危险因素，入院前已确诊有严重呼吸功能障碍，如 ARDS、急性呼吸衰竭、严重肺水肿等； 3、多次（>2 次）因肺炎入院或气管切开后需长期氧疗； 4、住院期间由其他科室转至综合 ICU 或呼吸内科； 5、住院时间<48h； 6、临床资料不完善； 7、年龄＜18 岁或≥80岁。

Exclusion criteria：

Exclusion criteria for CAP: 1. Patients with severe respiratory dysfunction, such as ARDS, acute respiratory failure, and severe pulmonary edema, had been diagnosed before the onset of CAP. 2. Long-term oxygen therapy is required after multiple (> 2) hospital admissions due to pneumonia or tracheotomy; 3. Transferred from other departments to comprehensive ICU or respiratory department during hospitalization; 4. Combined with other risk factors at admission; 5. Hospital stay <24h; 6. the clinical data is not perfect; 7. age < 18 years or ≥80 years old. HAP exclusion criteria: 1. Pneumonia present at admission or in the incubation period, pneumonia occurring less than 48 hours after hospitalization; 2. The patient was combined with other risk factors at admission, and had been diagnosed with severe respiratory dysfunction before admission, such as ARDS, acute respiratory failure, and severe pulmonary edema; 3. Long-term oxygen therapy is required after multiple (>2) hospital admissions due to pneumonia or tracheotomy; 4. Transferred from other departments to comprehensive ICU or respiratory department during hospitalization; 5. Duration of hospitalization <48h; 6. the clinical data is not perfect; 7. age < 18 years or ≥80 years old.

研究实施时间：

Study execute time：

从 From 2024-05-01 00:00:00至 To 2024-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2024-05-05 00:00:00 至 To 2024-12-31 00:00:00

干预措施：

Interventions：

组别：	对照组	样本量：	40
Group：	Control group	Sample size：	40
干预措施：	按目前重症肺炎诊疗方案常规诊疗	干预措施代码：
Intervention：	According to the current diagnosis and treatment of severe pneumonia routine	Intervention code：

组别：	实验组	样本量：	40
Group：	Experimental group	Sample size：	40
干预措施：	对使用模型预测进展至ARDS概率＞50%的患者，提前使用肺保护性通气及俯卧位通气等ARDS治疗方法。	干预措施代码：
Intervention：	Lung protective ventilation and prone ventilation were used in advance to treat ARDS patients whose probability of progression to ARDS was more than 50% predicted by the model.	Intervention code：

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：	zunyi
单位(医院)：	遵义医科大学第二附属医院	单位级别：	三甲
Institution hospital：	The Second Affiliated Hospital of Zunyi Medical University	Level of the institution：	Class III, Class A hospital

测量指标：

Outcomes：

指标中文名：	住院死亡率	指标类型：	主要指标
Outcome：	In-hospital mortality rate	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	住院期间呼吸机使用时间	指标类型：	次要指标
Outcome：	Ventilator use time during hospitalization	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	住院费用	指标类型：	次要指标
Outcome：	Hospitalization expenses	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	住院时间	指标类型：	次要指标
Outcome：	Hospital stay	Type：	Secondary 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：	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）：

由参加研究人员肖玄采用密闭信封法将患者随机分组

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

The patients were randomly grouped by closed envelope method by participating researcher Xiao Xuan

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：
Blinding：
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

是否共享原始数据： IPD sharing	是Yes
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://www.medresman.org.cn/html/ipd.pdf
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	http://www.medresman.org.cn/html/ipd.pdf
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：	采用病例记录表统计自愿加入研究并有完整数据的患者；采用电子采集和管理系统记录并收集病例一般资料、治疗相关资料、预后相关资料等。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	The patients who volunteered to join the study and had complete data were counted using the case record form; The electronic collection and management system was used to record and collect the general case data, treatment-related data and prognostic data.
数据与安全监察委员会： Data and Safety Monitoring Committee：	暂未确定/Not yet
注册人： Name of Registration：	2024-10-16 16:58:30