ChiCTR2400092340 版本V1.1 版本创建时间2025/12/19 10:59:48 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：

ChiCTR2400092340 

最近更新日期：

Date of Last Refreshed on：

2024-11-14 14:30:06 

注册时间：

Date of Registration：

2024-11-14 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

改良版 PEWS 量表在重症肺炎惠儿集束化管理中的应用研究

Public title：

Application of the modified PEWS scale in the cluster management of severe pneumonia infants

注册题目简写：

English Acronym：

研究课题的正式科学名称：

改良版PEWS量表对早期识别儿科危重症患儿的应用研究

Scientific title：

Application of modified PEWS scale to early identification of pediatric critically ill children

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：

林康 

研究负责人：

翁晓君 

Applicant：

Lin Kang 

Study leader：

Weng Xiaojun 

申请注册联系人电话：

Applicant telephone：

+86 134 1196 8518

研究负责人电话：

Study leader's telephone：

+86 134 1341 3251

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：

23klin@stu.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

565976838@qq.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

汕头大学医学院;汕头大学医学院第一附属医院

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：

广东省汕头市新陵路22号汕头大学医学院

研究负责人通讯地址：

广东省汕头市长平路57号汕头大学医学院第一附属医院

Applicant address：

School of Medicine, Shantou University, 22 Xinling Road, Shantou City, Guangdong Province

Study leader's address：

The First Affiliated Hospital of Shantou University Medical College, 57 Changping Road, Shantou City, Guangdong Province, China

申请注册联系人邮政编码：

Applicant postcode：

515832

研究负责人邮政编码：

Study leader's postcode：

515832

申请人所在单位：

汕头大学医学院

Applicant's institution：

Shantou University Medical School

研究负责人所在单位：

汕头大学医学院第一附属医院

Affiliation of the Leader：

The First Affiliated Hospital of Shantou University Medical College

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：

汕大医附一伦审第B-2021-212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：

汕头大学医学院第一附属医院临床科研伦理委员会

Name of the ethic committee：

Clinical Research Ethics Committee of the First Affiliated Hospital of Shantou University Medical College

伦理委员会批准日期：

Date of approved by ethic committee：

2021-11-22 00:00:00

伦理委员会联系人：

林宇洵

Contact Name of the ethic committee：

Lin Yuxun

伦理委员会联系地址：

广东省汕头市长平路57号

Contact Address of the ethic committee：

57 Changping Road, Shantou City, Guangdong Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 754 8890 5647

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：

汕头大学医学院第一附属医院

Primary sponsor：

The First Affiliated Hospital of Shantou University Medical College

研究实施负责（组长）单位地址：

广东省汕头市长平路57号

Primary sponsor's address：

57 Changping Road, Shantou City, Guangdong 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)：

广东省

市(区县)：

Country：

China

Province：

Guang Dong

City：

单位(医院)：

汕头大学医学院第一附属医院

具体地址：

汕头大学医学院第一附属医院一期四楼儿科

Institution
hospital：

The First Affiliated Hospital of Shantou University Medical College

Address：

Department of Pediatrics, fourth floor, the First Affiliated Hospital of Shantou University Medical College

经费或物资来源：

无

Source(s) of funding：

None

Target disease：

Pediatric intensive care unit

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：

1.探讨改良版 PEWS量表在识别儿科危重症患儿的应用效果； 2.探讨应用改良版PEWS量表后对儿科危重症患儿并发症（包括 意识障碍、晕厥、急性呼吸功能障碍、急性心肌梗死、心绞痛、休 克等）发生率、 死亡率、自动出院率、住院天数、平均住院费用、 医生满意度、患儿家长满意度的影响 3.探索儿童重症监护室推广使用改良版PEWS量表的可行性。  

Objectives of Study：

1. To explore the application effect of the modified PEWS scale in identifying pediatric critically ill children; 2. To explore the effect of the modified PEWS scale on the complications of pediatric critically ill children (including Impaired consciousness, syncope, acute respiratory dysfunction, acute myocardial infarction, angina, Hugh g, etc.), mortality, automatic discharge rate, length of hospital stay, average hospital cost, The effect of physician satisfaction and parental satisfaction 3. To explore the feasibility of promoting the use of the modified PEWS scale in pediatric intensive care units.

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.入住儿科病房的内科患儿； 2.由急诊、门诊收入； 3.年龄28ｄ～14岁； 4.家属沟通、交流、阅读、理解能力正常。

Inclusion criteria

1. Pediatric patients admitted to the ward 2. Admitted through emergency or outpatient departments 3. Age: 28 days to 14 years old 4.Family members possess normal communication, comprehension, reading, and understanding abilities.

排除标准：

1.急诊室登记资料不全，无法完成儿童早期预警评分； 2.患儿来院时已死亡未能评分； 3.近期内接受其他护理干预。

Exclusion criteria：

1.Incomplete registration data in the emergency room, preventing the completion of the early warning score for the child 2.The child was deceased upon arrival at the hospital, making scoring impossible 3.The child had received other nursing interventions recently.

研究实施时间：

Study execute time：

从 From 2021-06-01 00:00:00至 To 2023-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2021-11-29 00:00:00 至 To 2023-01-22 00:00:00  

干预措施：

Interventions：

组别：

对照组

样本量：

150

Group：

Control Group

Sample size：

干预措施：

对照组患儿根据医嘱进行相应治疗,采用常规基础护理和专科护理。

干预措施代码：

Intervention：

The control group received the prescribed treatment according to the doctor's instructions, along with standard basic nursing care and specialized nursing care.

Intervention code：

组别：

观察组

样本量：

150

Group：

Observation Group

Sample size：

干预措施：

1.快速评估：患儿入院后, 护理人员立即通知值班主治医师,并快速使用PEWS进行评估，配合医师评估患儿病情。根据临床症状表现、家长口述和基础检查简单分为轻症和重症。主要检查患儿意识、心跳、呼吸、肢端循环等。同时,护理人员与家属沟通, 快速了解患儿病史、发病过程。 2.分级护理管理：Ｎ1级护士负责评分0～1分区间患儿，无需特殊处理，按护理级别巡视；Ｎ2级护士负责评分2～3分区间患儿，通知责任组长给予相应的护理指导，每2ｈ巡视患儿1次；Ｎ3级护士负责评分为4分区间患儿，值班医生、责任护士15min之内查看患儿情况，初步处理，每小时巡视患儿1次；Ｎ4级及以上护士负责评分≥5分或出现灰色栏中的分区间患儿，值班医生、责任组长5min之内查看患儿情况，每30min巡视患儿1次， 如复评结果仍无改善， 医疗小组讨论修订治疗方案或转专科ICU进一步治疗。 3.个性化护理：护理人员配合主治医师快速开展各项床位分配、治疗工作,主要包含患儿的姓名、性别、年龄、既往病史、临床症状、当前生命体征、心理状况等多种信息,快速识别出有无呼吸困难、缺氧、意识丧失等危及生命的问题。根据主治医师对患儿病情的初期判定,护理人员遵医嘱实施采血、输液、雾化等紧急抢救措施,同时加强对患儿呼吸、心跳、血氧饱和度等各项生命体征指标变化情况进行密切观察。 4.家属宣教：最后是与患儿家属做好沟通,可以对家属进行健康知识宣教,提升家长对患儿疾病。

干预措施代码：

Intervention：

1.Rapid assessment: After the child is admitted to hospital, the nursing staff immediately notify the attending physician on duty, and quickly use PEWS for assessment, and cooperate with the doctor to evaluate the child's condition. According to the clinical symptoms, parents' dictation and basic examination, it can be divided into mild and severe. The main examination of consciousness, heartbeat, respiration, extremity circulation and so on. At the same time, the nursing staff communicated with the family members to quickly understand the medical history and the onset process of the child. 2. Graded nursing management: N1 nurses are responsible for grading children between 0 and 1 zones, without special treatment, and tour according to nursing level; N2 grade nurses were responsible for grading children between 2 and 3 zones, informing the responsible group leader to give corresponding nursing guidance, and visiting the children once every 2h. The N3 nurse is responsible for grading the children between 4 zones. The doctor on duty and the responsible nurse check the condition of the children within 15 minutes, make preliminary treatment, and inspect the children once every hour. Nurses with grade N4 and above shall be responsible for the children with scores ≥5 or those in the gray column. The doctor on duty and the leader in charge shall check the condition of the children within 5 minutes and visit the children once every 30 minutes. If the reevaluation results still do not improve, the medical team shall discuss to revise the treatment plan or transfer them to specialized ICU for further treatment. 3.Personalized care: the nursing staff cooperate with the treating physician to quickly carry out various bed allocation and treatment work, mainly including the name, gender, age, previous medical history, clinical symptoms, current vital signs, psychological status and other information of the child, and quickly identify whether there is dyspnea, hypoxia, loss of consciousness and other life-threatening problems. According to the initial judgment of the attending physician on the condition of the child, the nursing staff implemented emergency rescue measures such as blood collection, infusion and atomization according to the doctor's advice, and strengthened close observation of the changes in the vital signs indicators such as breathing, heartbeat and blood oxygen saturation of the child.4. Family education: Finally, communicate with the families of the children, you can educate the family about health knowledge, and improve the parents' understanding of the diseases of the children.

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)：

 汕头 

Country：

China 

Province：

Guang Dong 

City：

Shantou 

单位(医院)：

汕头大学医学院第一附属医院 

单位级别：

三甲 

Institution
hospital：

The First Affiliated Hospital of Shantou University Medical College

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

观察组儿童早期预警评分

指标类型：

主要指标

Outcome：

Observation group children early warning score

Type：

Primary indicator

测量时间点：

入院时

测量方法：

Measure time point of outcome：

At admission

Measure method：

指标中文名：

家长满意度

指标类型：

次要指标

Outcome：

Parent satisfaction

Type：

Secondary indicator

测量时间点：

出院时

测量方法：

在患儿出院当天发放满意度量表CSQ-8评估患儿家长对护理的满意度，量表包含8个条目，总分8～32分，8～16分：不满意或低满意度；17～24分：中等满意度；25～32分：高满意度。分值越高则满意度越高，统计两组总满意率。

Measure time point of outcome：

At discharge

Measure method：

On the day of discharge, the CSQ-8 satisfaction scale was issued to assess parental satisfaction with the nursing care. The scale includes 8 items, with total scores ranging from 8 to 32. Scores between 8 and 16 indicate unsatisfactory or low satisfaction, scores from 17 to 24 reflect medium satisfaction, and scores between 25 and 32 denote high satisfaction. A higher score signifies greater satisfaction. The total satisfaction rate for both groups was then calculated.

指标中文名：

比较两组治疗疗效

指标类型：

次要指标

Outcome：

The therapeutic effect of the two groups was compared

Type：

Secondary indicator

测量时间点：

出院时

测量方法：

治疗疗效包括住院天数、住院费用、死亡率、并发症发生率。并发症是指患儿医治护理过程中出现的额外健康问题或不良反应，包括急性呼吸功能障碍、急性心肌梗死、心绞痛、休克、心律失常、心跳呼吸骤停、脱水、低氧血症、腹泻、便秘等。以同一患儿的首次发生例次计算，发生率是将发生并发症的病例数除以总病例数，然后乘以100，得到并发症的发生率百分比。

Measure time point of outcome：

At discharge

Measure method：

The curative effect included hospitalization days, hospitalization cost, mortality rate and complication rate. Calculated as the first occurrence of the same child, the incidence rate is calculated by dividing the number of cases with complications by the total number of cases, and then multiplying by 100 to obtain the percentage of complications.

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：

结束

/Completed

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）：

选取2021年6月—2023年12月广东省某三级甲等医院普儿科收治的300例住院患者作为研究对象，按照随机数字表法分为试验组和对照组。随机化由一名独立研究员助理(未参与本研究)执行。不重复的随机数由计算机生成。主要研究人员收到按顺序编号的不透明密封信件，每个信件中都有一张卡片，上面的数字要么是1(干预组)，要么是2(对照组)。

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

A total of 300 inpatients admitted to the general pediatrics department of a Grade-III hospital in Guangdong Province from June 2021 to December 2023 were selected as study participants. They were divided into a test group and a control group using a random number table method. Randomization was performed by an independent investigator assistant who was not involved in the study. Non-duplicated random numbers were generated by a computer. The principal investigator received sequentially numbered, opaque sealed envelopes, each containing a card with either a 1 (intervention group) or a 2 (control group).

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：

单盲；对研究参与者设盲

Blinding：

Single-blind; Study participants were blinded

是否共享原始数据：

IPD sharing

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）：

研究结束后，通过邮箱与研究者联系

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

After the study is over, contact the investigator by email

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：

由经过专门培训的资料收集员对数据进行测量和采集。采用excel 2013、Epidate 建立数据库，为保证数据录入的准确性，所有数据均由双人录入，并采用SPSS、python软件进行数据处理。

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

Data are measured and collected by specially trained data collectors. Excel 2013 was used to establish the database. In order to ensure the accuracy of data entry, all data were entered by two people, and SPSS software was used for data processing.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2024-11-14 14:29:59