ChiCTR2500113765 版本V1.0 版本创建时间2025/12/03 08:38:15 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：

ChiCTR2500113765 

最近更新日期：

Date of Last Refreshed on：

2025-12-03 08:37:49 

注册时间：

Date of Registration：

2025-12-03 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

302（审核员标记请勿删除；1、确认征募研究观察对象起始日期，如为后补批件（首例知情同意书签署时间早于伦理批件获得时间），请咨询学校/医院科研管理部门先在国家医学研究登记备案信息系统（https://www.medicalresearch.org.cn/login）备案，将含备案号、研究负责人及“是否在中国临床试验注册中心公开信息”的页面截图，及首例签署的知情同意书脱敏处理后与正式签章的伦理批件并为一个文件上传；2、请在“干预措施”处分栏分别完善实验分组信息。3、此为补注册，需填写原始数据的共享方式和计划时间（注册表下方的数据共享方式栏），可使用国内公网能查看到的数据存放平台（EDC，可选择共享或不共享，参考注册指南第十条）。 不同排痰方式对重症肺炎机械通气患儿气道阻力和肺顺应性的影响

Public title：

To investigate the effects of different expectoration methods on airway resistance and lung compliance in mechanically ventilated children with severe pneumonia

注册题目简写：

English Acronym：

研究课题的正式科学名称：

不同排痰方式对重症肺炎机械通气患者气道阻力和肺顺应性的影响

Scientific title：

The effects of different expectoration methods on airway resistance and lung compliance in mechanically ventilated patients 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：

段晓媛 

研究负责人：

许巍 段晓媛 

Applicant：

Duan Xiaoyuan 

Study leader：

Xu Wei Duan Xiaoyuan 

申请注册联系人电话：

Applicant telephone：

+86 158 4028 2018

研究负责人电话：

Study leader's telephone：

+86 158 4028 2018

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：

dxy18944033155@163.com

研究负责人电子邮件：

Study leader's E-mail：

dxy18944033155@163.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：

中国辽宁省沈阳市和平区三好街36号

研究负责人通讯地址：

中国辽宁省沈阳市和平区三好街36号

Applicant address：

36 Sanhao Street, Heping District, Shenyang City, Liaoning Province, China

Study leader's address：

36 Sanhao Street, Heping District, Shenyang City, Liaoning Province, 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：

中国医科大学附属盛京医院

Applicant's institution：

Shengjing Hospital Affiliated to China Medical University

研究负责人所在单位：

中国医科大学附属盛京医院

Affiliation of the Leader：

Shengjing Hospital Affiliated to China 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：

2023PS729K

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：

中国医科大学附属盛京医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Shengjing Hospital of China Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

2023-04-19 00:00:00

伦理委员会联系人：

赵玉虹

Contact Name of the ethic committee：

Zhao Yuhong

伦理委员会联系地址：

中国辽宁省沈阳市和平区三好街36号

Contact Address of the ethic committee：

36 Sanhao Street, Heping District, Shenyang City, Liaoning Province, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 24 966 151 0027

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：

中国医科大学附属盛京医院

Primary sponsor：

Shengjing Hospital Affiliated to China Medical University

研究实施负责（组长）单位地址：

中国辽宁省沈阳市和平区三好街36号

Primary sponsor's address：

36 Sanhao Street, Heping District, Shenyang City, Liaoning Province, 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)：

辽宁

市(区县)：

沈阳

Country：

China

Province：

Liaoning

City：

Shenyang

单位(医院)：

中国医科大学附属盛京医院

具体地址：

中国辽宁省沈阳市和平区三好街36号

Institution
hospital：

Shengjing Hospital Affiliated to China Medical University

Address：

36 Sanhao Street, Heping District, Shenyang City, Liaoning Province, China

经费或物资来源：

自筹

Source(s) of funding：

Self-funded

Target disease：

Severe pneumonia in children

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 I期临床试验 

Study phase：

1

研究设计：

随机交叉对照 

Study design：

Cross-over 

研究目的：

对照观察徒手扣背吸痰与康复师行膈肌康复训练及辅助排痰方法对PICU内重症肺炎机械通气患儿的呼吸力学中反映气道阻力及顺应性的指标以及膈肌自主运动的指标，评估两种排痰方式对气道清理的状态以及效果评价。  

Objectives of Study：

To compare and observe the respiratory mechanics indexes reflecting airway resistance, compliance and diaphragm voluntary movement in children with severe pneumonia and mechanical ventilation in PICU by using unarmed back suction and diaphragmatic rehabilitation training and auxiliary sputum excretion methods, and to evaluate the status and effect of two sputum excretion methods on airway clearance.

药物成份或治疗方案详述：

对照组行传统的徒手扣背排痰方法：每次喂养前空腹状态下，患者取平卧位或侧卧位，操作者五指并拢呈空心状，用腕部力量从由下至上、从外至内叩击患者胸壁或背部，避开脊柱，对于不能翻身患者叩击前胸和两肋部位，缓慢移动，避开心脏、胃肠等部分；于患者肺下叶和感染部位、痰鸣音明显部位适当增加叩击频率、延长叩击时间，力度以患者耐受、皮肤不变潮红为宜，平均叩击频率以30～40次 /min,每个肺叶叩击1～2min，间断进行。 干预组由康复治疗师行肺康复手法辅助排痰： 每次喂养前空腹状态下，患者取平卧位，方法包括手法振动与摇动、呼吸引导与呼吸肌阻力训练、呼吸控制与胸廓扩张，具体措施如下： （1）手法振动与摇动:先将双手放于患者侧胸壁或腹部感受患者呼气相和吸气相,吸气时不施加压力随患者吸气手慢慢上抬,然后在患者呼气末给予痰鸣音听诊明显部位快速高频振动,以促进细小支气管痰液松动排入大气道。时间1-2分钟/次,间断进行。 （2）呼吸引导与呼吸肌阻力训练:将双手放于患者下胸廓膈肌两侧感知患者呼气相和吸气相,通过腹部或侧胸部适度力量加压,对患者进行腹式呼吸引导;吸气阻力训练是指治疗师双手放在两侧肋间,在患者呼气时手向内向下用力,吸气时感到患者腹部上抬对抗双手恢复至原位。目的在于纠正患者呼吸模式,增强腹式呼吸,锻炼膈肌吸气,防止患者出现肺不张和膈肌废用性萎缩。时间1-2分钟/次,间断进行。 （3）呼吸控制与胸廓扩张;将双手放在有肺不张或肺部听诊呼吸音较弱部位的对侧,通过胸廓适当加压和手法引导患者下肺部呼吸,促进患者患侧肺部复张和腹式呼吸;胸廓扩张指治疗师手放在患者欲扩张的胸廓上嘱患者鼓气约2-3秒后缓慢呼气。主被动均可进行,时间1-2分钟/次,根据患者耐力间断进行。 注:早期肺康复手法辅助排痰整体干预时间为15-30分钟为宜,在患者病情和血流动力学稳定、血氧饱和度大于90%、严密监测患者生命体征下由康复治疗师主导,管床护士协助研究者、治疗师共同完成。具体措施以病情评估和患者实际需要由康复治疗师决定。干预措施中的早期肺-膈肌康复措施参考既往文献。  

Description for medicine or protocol of treatment in detail：

Before each feeding, the patient was placed in the supine position or lateral position, and the operator's five fingers were together in a hollow shape. The operator tapped the chest wall or back of the patient from bottom to top, from outside to inside, avoiding the spine. For patients who could not turn over, they tapped the chest and two ribs, and moved slowly, avoiding the heart, gastrointestinal and other parts. The frequency and duration of tapping were increased appropriately in the lower lobe of the lung, the infection site and the area with obvious phlegm, and the intensity of tapping should be tolerated by the patient without skin flushing. The average frequency of tapping was 30-40 times /min, and each lobe was knocked for 1-2 min intermittently. In the intervention group, the patients were placed in the supine position in the fasting state before each feeding. The methods included manual vibration and shaking, breathing guidance and respiratory muscle resistance training, breathing control and chest expansion. The specific measures were as follows: (1) Manual vibration and shaking: first, place both hands on the side of the chest wall or abdomen of the patient to feel the expiratory and inspiratory phases of the patient, and slowly lift the inspiratory hand with the patient without pressure during inspiration. Then, at the end of exhalation, give rapid high-frequency vibration to the obvious part of the sputum whine ausculation, so as to promote the loosening of small bronchial sputum into the large airway. Time 1-2 minutes/time, intermittent. (2) Respiratory guidance and respiratory muscle resistance training: the hands were placed on both sides of the patient's lower thoracic diaphragm to sense the expiratory and inspiratory phases of the patient, and the abdominal breathing was guided by moderate pressure from the abdomen or side chest. In inspiratory resistance training, the therapist places both hands between the sides of the ribs, and when the patient exhale, the hands are forced inward and downward. During inhalation, the patient's abdomen is lifted, and the hands are returned to the same position. The aim is to correct the patient's breathing pattern, enhance abdominal breathing, exercise diaphragmatic inspiration, and prevent atelectasis and disuse atrophy of the diaphragm. Time 1-2 minutes/time, intermittent. (3) respiratory control and chest expansion; Put both hands on the opposite side of the part with atelectasis or weak breath sounds on pulmonary auscultation, guide the patient's lower lung breathing through appropriate chest pressure and manipulation, and promote the patient's lung recruitment and abdominal breathing on the affected side. Chest distension refers to the therapist placing his hand on the patient's chest to expand and telling the patient to exhale slowly after about 2-3 seconds of exhale. Active and passive can be carried out, the time is 1-2 minutes/time, intermittent according to the patient's tolerance. Note: The overall intervention time of early pulmonary rehabilitation manual assisted sputum excretion is 15-30 minutes, which is led by rehabilitation therapists and assisted by bedside nurses when the patient's condition and hemodynamics are stable, the blood oxygen saturation is greater than 90%, and the vital signs of patients are closely monitored. The specific measures were determined by the rehabilitation therapist based on the assessment of the condition and the actual needs of the patient. Early pulmonary-diaphragmatic rehabilitation was referred to previous literature. 

纳入标准：

1. 年龄 <= 14岁； 2. 符合机械通气应用标准； 3. 心率处于同年龄段10-90th百分位，平均动脉压60～110 mmHg；经皮血氧饱和度（SpO2）> 90%、呼气末正压（PEEP）<= 10 cmH?O、呼吸频率 <= 同年龄段10-90th百分位 次/min；血管活性药物剂量：多巴胺 < 10 μg·kg?1·min?1；（去甲）肾上腺素 < 0.1 μg·kg?1·min?1； 4. 无CPT禁忌症（严重心律失常、颅内压高未受控制者、气胸（未经处理者）、严重凝血功能障碍者、严重气管痉挛、不稳定性骨折）； 5. 无早期活动禁忌症（不稳定性骨折、活动性出血、关节脱位或半脱位，呼吸循环极不稳定等）； 6. 经主管医生评估患者机械通气时间 >= 3天，住院时间 >= 5天； 7. 患者家属知情同意。

Inclusion criteria

1. age <= 14 years old; 2. meet the application standards of mechanical ventilation; 3. heart rate 10–90th percentile, mean arterial pressure 60–110 mmHg; transcutaneous oxygen saturation (SpO?) > 90%, positive end-expiratory pressure (PEEP) <= 10 cmH?O, respiratory rate <= 10–90th percentile breaths/min for the same age group; vasoactive drug dose: dopamine < 10 μg·kg?1·min?1; (norepinephrine) epinephrine < 0.1 μg·kg?1·min?1; 4. no CPT contraindications (severe arrhythmia, uncontrolled intracranial hypertension, pneumothorax [untreated], severe coagulation dysfunction, severe tracheal spasm, unstable fracture); 5. no contraindications to early mobilization (unstable fracture, active bleeding, joint dislocation or subluxation, hemodynamic or respiratory instability, etc.); 6. duration of mechanical ventilation >= 3 days and length of hospital stay >= 5 days as assessed by the attending physician; 7. informed consent from patient’s family members.

排除标准：

1. Received mechanical ventilation prior to ICU admission; 2. Use of neuromuscular blocking agents during mechanical ventilation; 3. Post-cardiopulmonary resuscitation (post-CPR); 4. Required extracorporeal life support; 5. Severe pediatric acute respiratory distress syndrome (PARDS), intervention implemented only when permitted by dynamic assessment of condition by the attending physician, otherwise excluded; 6. Presence of life-threatening organ failure (e.g., hepatic or renal failure) requiring extracorporeal circulation support.

Exclusion criteria：

1. receiving mechanical ventilation before ICU admission; 2. use of muscle relaxants during mechanical ventilation; 3. after cardiopulmonary resuscitation; 4. need for extracorporeal life support; 5. for children with severe acute respiratory distress syndrome, intervention should be implemented only when permitted by dynamic assessment of the attending physician; otherwise, exclusion applies; 6. presence of life-threatening organ failure such as liver or kidney failure requiring extracorporeal circulation.

研究实施时间：

Study execute time：

从 From 2023-04-20 00:00:00至 To 2024-02-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2023-04-20 00:00:00 至 To 2024-02-01 00:00:00  

干预措施：

Interventions：

组别：

交叉组1

样本量：

50

Group：

Crossover Group 1

Sample size：

干预措施：

第1天上午接受1次传统扣背吸痰，第1天下午接受1次康复师辅助排痰；次日上午再次接受1次康复师辅助排痰

干预措施代码：

Intervention：

On the morning of Day 1, receive one session of traditional chest percussion and suctioning; on the afternoon of Day 1, receive one session of rehabilitation therapist-assisted sputum clearance; on the morning of the next day, receive another session of rehabilitation therapist-assisted sputum clearance.

Intervention code：

组别：

交叉组2

样本量：

50

Group：

Crossover Group 2

Sample size：

干预措施：

第1天上午接受1次康复师辅助排痰，第1天下午接受1次传统扣背吸痰；次日上午再次接受1次传统扣背吸痰

干预措施代码：

Intervention：

On the morning of Day 1, receive one session of rehabilitation therapist-assisted sputum clearance; on the afternoon of Day 1, receive one session of traditional chest percussion and suctioning; on the morning of the next day, receive another session of traditional chest percussion and suctioning.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 辽宁 

市(区县)：

 沈阳 

Country：

China 

Province：

Liaoning 

City：

Shenyang 

单位(医院)：

中国医科大学附属盛京医院 

单位级别：

三甲 

Institution
hospital：

Shengjing Hospital of China Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

干预前及干预后1min,5min，15min,30min患儿呼吸力学参数：通气模式、插管内径（cm）、插管深度（cm）、气道阻力（Paw）、动态肺顺应性（Cydn）、气道闭合压（P0.1）、P-V曲线环、潮气量（Vt）、总呼气末正压 (PEEPtot)、气道峰值压力 (Ppeak) 和气道平台（Pplat）、PEEPi、Pdriv (Pplat - PEEPtot)

指标类型：

主要指标

Outcome：

Respiratory mechanics parameters of (pediatric patients) before intervention and at 1 min, 5 min, 15 min, and 30 min after intervention: ventilation mode, endotracheal tube inner diameter (cm), intubation depth (cm), airway resistance (Paw), dynamic lung compliance (Cydn), airway occlusion pressure (P0.1), P-V loop, tidal volume (Vt), total positive end-expiratory pressure (PEEPtot), peak airway pressure (Ppeak), plateau pressure (Pplat), intrinsic PEEP (PEEPi), and driving pressure (Pdriv =

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

干预前及干预后血气分析指标：动脉血氧分压(PaO2)、动脉血二氧化碳分压（PaCO2)

指标类型：

主要指标

Outcome：

Blood gas analysis parameters before and after intervention: arterial partial pressure of oxygen (PaO?), arterial partial pressure of carbon dioxide (PaCO?).

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

排痰后痰液黏稠度及排痰量

指标类型：

主要指标

Outcome：

Sputum viscosity and sputum volume after expectoration.

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

其他指标：机械通气时间（h）、PICU住院时间及总住院时间（d）、 APACHEⅡ评分、CPIS评分、PELOD-2评分

指标类型：

主要指标

Outcome：

Other indicators: duration of mechanical ventilation (h), PICU length of stay and total hospital length of stay (d), APACHEⅡ score, CPIS score, PELOD-2 score.

Type：

Primary 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：

无

Sample Name：

None

Tissue：

None

人体标本去向

 其它  

说明

无

Fate of sample：

0thers  

Note：

None

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 0 岁 years
最大 Max age 14 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）：

符合条件的患者，在Redcap系统录入基本信息，系统进行随机分组，分为A组或B组。

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

Eligible patients entered basic information in the Redcap system, and the system was randomly divided into group A or group B.

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：

无

Blinding：

None

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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）：

研究结束后一年，通过国家生物信息中心https://www.cncb.ac.cn共享

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

One year after the completion of the study, data will be shared through the China National Center for Bioinformation at https://www.cncb.ac.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：

基于病例记录表和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：

Based on case record forms and an electronic collection and management system

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：

  2025-12-03 08:37:49