ChiCTR2600126722 版本V1.0 版本创建时间2026/06/15 09:58:12 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：

ChiCTR2600126722 

最近更新日期：

Date of Last Refreshed on：

2026-06-15 09:58:00 

注册时间：

Date of Registration：

2026-06-15 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

HFNC 联合序贯多体位管理在婴儿重症肺炎气道廓清护理中的应用研究

Public title：

Application of Heated Humidified High-Flow Nasal Cannula Therapy Combined with Sequential Multi-Positioning in Airway Clearance Nursing for Infants with Severe Pneumonia

注册题目简写：

English Acronym：

研究课题的正式科学名称：

HFNC 联合序贯多体位管理在婴儿重症肺炎气道廓清护理中的应用研究

Scientific title：

Application of Heated Humidified High-Flow Nasal Cannula Therapy Combined with Sequential Multi-Positioning in Airway Clearance Nursing for Infants with Severe Pneumonia

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：

庄雯苑 

研究负责人：

庄雯苑 

Applicant：

Wenyuan Zhuang 

Study leader：

Wenyuan Zhuang 

申请注册联系人电话：

Applicant telephone：

+86 577 88002714

研究负责人电话：

Study leader's telephone：

+86 577 88002714

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：

490265513@qq.com

研究负责人电子邮件：

Study leader's E-mail：

490265513@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：

中国浙江省温州市龙湾区温州大道(东段)1111号

研究负责人通讯地址：

中国浙江省温州市龙湾区温州大道(东段)1111号

Applicant address：

No. 1111, Wenjiang Avenue (East Section), Longwan District, Wenzhou, Zhejiang, China

Study leader's address：

No. 1111, Wenjiang Avenue (East Section), Longwan District, Wenzhou, Zhejiang, 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：

温州医科大学附属第二医院

Applicant's institution：

The Second Affiliated Hospital of Wenzhou Medical University

研究负责人所在单位：

温州医科大学附属第二医院

Affiliation of the Leader：

The Second Affiliated Hospital of Wenzhou Medical University

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：

伦审（2026-K-250-01）

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：

温州医科大学附属第二医院 温州医科大学附属育英儿童医院医学伦理委员会

Name of the ethic committee：

Research Ethics Committee of of the Second Affiliated Hospital of Wenzhou Medical University and Yuying Children's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2026-05-01 00:00:00

伦理委员会联系人：

陈苑

Contact Name of the ethic committee：

Chen Yuan

伦理委员会联系地址：

中国浙江省温州市龙湾区温州大道（东段）1111号

Contact Address of the ethic committee：

No. 1111, Wenjiang Avenue (East Section), Longwan District, Wenzhou, Zhejiang, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 577 85676879

伦理委员会联系人邮箱：

Contact email of the ethic committee：

feykjkcy@126.com

研究实施负责（组长）单位：

温州医科大学附属第二医院

Primary sponsor：

The Second Affiliated Hospital of Wenzhou Medical University

研究实施负责（组长）单位地址：

中国浙江省温州市龙湾区温州大道（东段）1111号

Primary sponsor's address：

No. 1111, Wenjiang Avenue (East Section), Longwan District, Wenzhou, Zhejiang, 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)：

浙江

市(区县)：

Country：

China

Province：

Zhejiang

City：

单位(医院)：

温州医科大学附属第二医院

具体地址：

中国浙江省温州市龙湾区温州大道（东段）1111号

Institution
hospital：

The Second Affiliated Hospital of Wenzhou Medical University

Address：

No. 1111, Wenjiang Avenue (East Section), Longwan District, Wenzhou, Zhejiang, China

经费或物资来源：

自筹

Source(s) of funding：

Self-funding

Target disease：

Severe pneumonia in infants. Major manifestations include hypoxemia, respiratory distress, retained airway secretions, and impaired airway clearance.

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.评价HFNC联合序贯多体位管理在婴儿重症肺炎气道廓清护理中的应用效果。 2.探讨HFNC联合序贯多体位管理对患儿排痰效率、氧合水平、病情恢复及护理安全性的影响。  

Objectives of Study：

1.To evaluate the effectiveness of HFNC combined with sequential multi-position management in airway clearance nursing for infants with severe pneumonia.2.To explore the effects of HFNC combined with sequential multi-position management on sputum clearance, oxygenation, disease recovery, and nursing safety in infants with 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：

1.年龄为2月龄至12月龄的婴儿；
2.符合重症肺炎诊断标准，依据《儿童社区获得性肺炎管理指南（2024修订）》中住院及危险征象标准，存在拒食、持续呕吐、嗜睡或意识障碍、中心性发绀、严重呼吸困难，或SpO?＜92%等表现之一。
3.经临床评估需接受加温湿化高流量鼻导管氧疗（HFNC）治疗，包括中度低氧血症、常规氧疗效果不佳、需缓解呼吸窘迫或减少呼吸作功者。
4.HFNC启动后12小时内完成入组及基线评估。
5.生命体征相对稳定，SpO?≥92%或较基线稳定，心率及呼吸频率在月龄参考范围±20%以内，循环平稳，无立即气管插管指征。
6.在医护人员或家属辅助下可完成体位变换。
7.患儿父母或法定监护人知情同意并签署知情同意书。

Inclusion criteria

1.Infants aged 2 to 12 months.
2.Diagnosed with severe pneumonia according to the hospitalization and danger signs criteria in the Guidelines for the Management of Community-Acquired Pneumonia in Children 2024 revision, with at least one of the following manifestations: refusal to feed, persistent vomiting, lethargy or disturbed consciousness, central cyanosis, severe respiratory distress, or SpO? below 92%.
3.Clinically assessed as requiring heated humidified high-flow nasal cannula oxygen therapy HFNC, including infants with moderate hypoxemia, inadequate response to conventional oxygen therapy, respiratory distress, or increased work of breathing.
4.Enrollment and baseline assessment completed within 12 hours after HFNC initiation.
5.Relatively stable vital signs, with SpO? at or above 92% or stable compared with baseline, heart rate and respiratory rate within ±20% of the age-specific reference range, stable circulation, and no immediate indication for endotracheal intubation.
6.Able to complete position changes with assistance from medical staff or caregivers.
7.Written informed consent provided by parents or legal guardians.

排除标准：

1.合并重大结构性肺部疾病者，如肺结核、支气管肺发育异常、先天性肺囊肿等。
2.存在HFNC治疗禁忌者：如需紧急插管、频繁呼吸暂停需持续干预、未经治疗的气胸、严重意识障碍等，或因严重面部畸形/损伤无法妥善佩戴鼻塞者。
3.合并严重心脏病、神经系统疾病或其他影响体位改变的基础疾病者。
4.出现循环不稳定（如持续低血压、严重心律失常）或颅脑损伤、颅内高压等不宜体位干预的情况。
5.合并严重营养不良、免疫缺陷或恶性肿瘤等，可能显著影响病程及结局判定者。
6.发育落后如尚不能抬头，抬头不稳者；
7.正在参与其他干预性临床研究者；
8.家属拒绝参与本研究流程或中途退出者。

Exclusion criteria：

1.Patients with major structural lung diseases, such as pulmonary tuberculosis, bronchopulmonary dysplasia, or congenital pulmonary cysts.
2.Patients with contraindications to HFNC therapy, such as the need for emergency intubation, frequent apnea requiring continuous intervention, untreated pneumothorax, severe disturbance of consciousness, or inability to properly wear nasal prongs due to severe facial deformity or injury.
3.Patients with severe heart disease, neurological disorders, or other underlying conditions that may affect positional changes.
4.Patients with circulatory instability, such as persistent hypotension or severe arrhythmia, or conditions unsuitable for positional intervention, such as traumatic brain injury or intracranial hypertension.
5.Patients with severe malnutrition, immunodeficiency, malignant tumors, or other conditions that may significantly affect the disease course and outcome assessment.
6.Infants with developmental delay, such as those who are unable to lift their head or have unstable head control.
7.Patients who are currently participating in other interventional clinical studies.
8.Patients whose family members refuse to participate in the study procedures or withdraw from the study midway.

研究实施时间：

Study execute time：

从 From 2026-04-01 00:00:00至 To 2028-09-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-06-15 00:00:00 至 To 2027-12-31 00:00:00  

干预措施：

Interventions：

组别：

干预组

样本量：

30

Group：

Intervention group

Sample size：

干预措施：

HFNC联合序贯多体位护理

干预措施代码：

Intervention：

HFNC combined with sequential multi-position nursing

Intervention code：

组别：

对照组

样本量：

30

Group：

Control group

Sample size：

干预措施：

HFNC常规氧疗护理

干预措施代码：

Intervention：

HFNC combined with sequential multi-position nursing

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 浙江 

市(区县)：

  

Country：

China 

Province：

Zhejiang 

City：

 

单位(医院)：

温州医科大学附属第二医院 

单位级别：

三级甲等 

Institution
hospital：

The Second Affiliated Hospital of Wenzhou Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

儿童早期预警评分

指标类型：

次要指标

Outcome：

Pediatric Early Warning Score

Type：

Secondary indicator

测量时间点：

T0、T1、T2、T3及每次体位护理后30分钟。

测量方法：

用儿童早期预警评分量表（PEWS）进行动态评估，反映呼吸、循环及神经状态变化。

Measure time point of outcome：

T0, T1, T2, T3, and 30 minutes after each positioning intervention.

Measure method：

The Pediatric Early Warning Score PEWS will be used for dynamic assessment of respiratory, circulatory, and neurological status.

指标中文名：

氧合改善

指标类型：

次要指标

Outcome：

Improvement in oxygenation

Type：

Secondary indicator

测量时间点：

T0、T1、T2、T3。T0为入组基线，T1为体位序列正式启动前再次稳定性复核时点，T2为体位序列启动后48 h，T3为出院前或72 h。

测量方法：

在各时点记录SpO?、FiO?及HFNC流量，计算S/F比值；同时记录HFNC治疗总时长及FiO?降至≤30%所需时间，用于评估氧合改善程度和脱氧依赖情况。

Measure time point of outcome：

T0, T1, T2, and T3. T0: baseline; T1: reassessment before formal initiation of the positioning seque

Measure method：

SpO?, FiO?, and HFNC flow will be recorded at each timepoint, and the S/F ratio will be calculated. Total duration of HFNC therapy and time required for FiO? reduction to ≤30% will also be recorded to assess oxygenation improvement and oxygen dependence.

指标中文名：

按指征吸痰频率

指标类型：

次要指标

Outcome：

Indicated suction frequency

Type：

Secondary indicator

测量时间点：

研究期间连续记录，重点分析T0至T2阶段；同时记录首次无吸痰需求时间。

测量方法：

记录按指征吸痰频率，以次/10患者小时表示；同时记录首次无吸痰需求时间，定义为连续≥12小时无吸痰。

Measure time point of outcome：

Continuously recorded throughout the study, with emphasis on the period from T0 to T2; time to first

Measure method：

Indicated suction frequency will be recorded and expressed as episodes per 10 patient-hours. Time to first no-suction requirement will also be recorded, defined as at least 12 consecutive hours without suction.

指标中文名：

炎症水平变化

指标类型：

次要指标

Outcome：

Change in inflammatory markers

Type：

Secondary indicator

测量时间点：

T0、T2。

测量方法：

检测白细胞计数（WBC）、C反应蛋白（CRP）及降钙素原（PCT）水平，比较两时点变化。

Measure time point of outcome：

T0 and T2.

Measure method：

White blood cell count WBC, C-reactive protein CRP, and procalcitonin PCT will be tested and compared between T0 and T2.

指标中文名：

肺部超声评分变化（ΔLUS）

指标类型：

主要指标

Outcome：

Change in lung ultrasound score（ΔLUS）

Type：

Primary indicator

测量时间点：

T0、T2、T3。其中T0为入组基线（HFNC启动≤12 h内），T2为体位序列启动后48 h，T3为出院前或72 h；主要结局分析采用T0至T2的变化值。

测量方法：

采用肺部超声12分区评分法（LUS）进行测量，每区按0–3分评分，总分0–36分，由经统一培训且对分组信息设盲的超声科医师完成评估。以ΔLUS反映肺部病变吸收及气道廓清效果。

Measure time point of outcome：

T0, T2, and T3. T0: baseline within 12 hours after HFNC initiation; T2: 48 hours after starting the

Measure method：

The 12-zone lung ultrasound scoring system will be used. Each zone is scored from 0 to 3, with a total score ranging from 0 to 36. Assessment will be performed by a trained ultrasonography physician blinded to group allocation. The change in LUS ΔLUS will be used to reflect lung lesion absorption and airway clearance efficacy.

指标中文名：

HFNC相关不良事件

指标类型：

次要指标

Outcome：

HFNC-related adverse events

Type：

Secondary indicator

测量时间点：

研究期间全程监测并记录。

测量方法：

记录鼻部损伤、胃胀或返流、持续低氧、高碳酸血症、管路脱落等不良事件的发生时间、严重程度、处理措施及结局。

Measure time point of outcome：

Continuously monitored throughout the study period.

Measure method：

HFNC-related adverse events including nasal injury, abdominal distension or reflux, persistent hypoxemia, hypercapnia, and tube dislodgement will be recorded, together with occurrence time, severity, management, and outcomes.

指标中文名：

住院总时长与治疗转归

指标类型：

次要指标

Outcome：

Length of hospital stay and treatment outcome

Type：

Secondary indicator

测量时间点：

出院时或研究观察终点T3时评估。T3定义为出院前或72 h。

测量方法：

记录患儿自入院至出院的总住院时长，并根据最终临床结局判定治疗转归，包括好转、转入ICU、接受机械通气或死亡。

Measure time point of outcome：

Assessed at discharge or at the study endpoint T3. T3 is defined as before discharge or at 72 hours.

Measure method：

Total length of hospital stay will be recorded from admission to discharge. Final treatment outcomes will be classified as improvement, transfer to ICU, mechanical ventilation, or death.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

N/A

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 0 岁 years
最大 Max age 1 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）：

由独立统计人员采用计算机生成区组随机序列，按照1:1比例将研究对象分配至对照组和干预组。

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

The random sequence will be generated by an independent statistician using computer-based block randomization in a 1:1 ratio to allocate participants into the control group and the intervention 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：

开放标签，对评估者隐藏分组

Blinding：

Open-label study with blinded-evaluators

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）：

无

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

None

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：

病例记录表，电子采集和管理系统

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

Case report form and electronic data capture.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-06-15 09:58:00