ChiCTR2600117767 版本V1.0 版本创建时间2026/01/28 15:38:45 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：

ChiCTR2600117767 

最近更新日期：

Date of Last Refreshed on：

2026-01-28 15:38:40 

注册时间：

Date of Registration：

2026-01-28 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

改良冲封管手法对静脉胸式输液港最佳维护时间探索研究

Public title：

Exploration of the Optimal Maintenance Time for Intravenous Thoracic Port via Improved Insertion and Sealing Technique

注册题目简写：

English Acronym：

研究课题的正式科学名称：

改良冲封管手法对静脉胸式输液港最佳维护时间探索研究

Scientific title：

Exploration of the Optimal Maintenance Time for Intravenous Thoracic Port via Improved Insertion and Sealing Technique

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：

于云 

研究负责人：

于云 

Applicant：

Yu Yun 

Study leader：

Yu Yun 

申请注册联系人电话：

Applicant telephone：

+86 189 3577 8810

研究负责人电话：

Study leader's telephone：

+86 189 3577 8810

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：

18935778810@163.com

研究负责人电子邮件：

Study leader's E-mail：

18935778810@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：

新疆维吾尔自治区伊犁哈萨克自治州伊宁市斯大林街92号

研究负责人通讯地址：

新疆维吾尔自治区伊犁哈萨克自治州伊宁市斯大林街92号

Applicant address：

No. 92, Stalin Street, Yining City, Ili Kazakh Autonomous Prefecture, Xinjiang Uygur Autonomous Region

Study leader's address：

No. 92, Stalin Street, Yining City, Ili Kazakh Autonomous Prefecture, Xinjiang Uygur Autonomous Region

申请注册联系人邮政编码：

Applicant postcode：

835000

研究负责人邮政编码：

Study leader's postcode：

835000

申请人所在单位：

新疆维吾尔自治区伊犁哈萨克自治州友谊医院

Applicant's institution：

Friendship Hospital of Yili Kazakh Autonomous Prefecture, Xinjiang Uygur Autonomous Region

研究负责人所在单位：

新疆维吾尔自治区伊犁哈萨克自治州友谊医院

Affiliation of the Leader：

Friendship Hospital of Yili Kazakh Autonomous Prefecture, Xinjiang Uygur Autonomous Region

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：

伦审科研第RMB2026-01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：

伊犁哈萨克自治州友谊医院科技伦理委员会

Name of the ethic committee：

The Science and Technology Ethics Committee of Friendship Hospital of Yili Kazakh Autonomous Prefecture

伦理委员会批准日期：

Date of approved by ethic committee：

2025-10-14 00:00:00

伦理委员会联系人：

江雅丽

Contact Name of the ethic committee：

Jiang Yali

伦理委员会联系地址：

新疆维吾尔自治区伊犁哈萨克自治州伊宁市斯大林街92号

Contact Address of the ethic committee：

No. 92, Stalin Street, Yining City, Ili Kazakh Autonomous Prefecture, Xinjiang Uygur Autonomous Region

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 999 772 0559

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：

新疆维吾尔自治区伊犁哈萨克自治州友谊医院

Primary sponsor：

The Science and Technology Ethics Committee of Friendship Hospital of Yili Kazakh Autonomous Prefecture

研究实施负责（组长）单位地址：

新疆维吾尔自治区伊犁哈萨克自治州伊宁市斯大林街92号

Primary sponsor's address：

No. 92, Stalin Street, Yining City, Ili Kazakh Autonomous Prefecture, Xinjiang Uygur Autonomous Region

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

新疆

市(区县)：

伊宁

Country：

China

Province：

Xinjiang

City：

Yining

单位(医院)：

新疆维吾尔自治区伊犁哈萨克自治州友谊医院

具体地址：

新疆维吾尔自治区伊犁哈萨克自治州伊宁市斯大林街92号

Institution
hospital：

Friendship Hospital of Yili Kazakh Autonomous Prefecture, Xinjiang Uygur Autonomous Region

Address：

No. 92, Stalin Street, Yining City, Ili Kazakh Autonomous Prefecture, Xinjiang Uygur Autonomous Region

经费或物资来源：

新疆维吾尔自治区卫生健康委员会

Source(s) of funding：

Xinjiang Uygur Autonomous Region Health Commission

Target disease：

Tumors

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.运用改良180°正负恒压法冲封管使输液港治疗间歇期维护时长至16周不会发生堵管、血栓、感染。 2.提高伊犁地区输液港维护水平。 3.节约护患时间成本，节约医疗资源，提高患者生活质量。  

Objectives of Study：

1. By using the improved 180° positive and negative constant pressure method for catheter sealing, the maintenance period of the infusion port during the treatment interval can be extended to 16 weeks without any problems such as tube blockage, thrombosis, or infection. 2. Improve the maintenance level of infusion ports in the Yili region. 3. Save the time cost for nurses and patients, save medical resources, and improve the quality of life of patients.

药物成份或治疗方案详述：

1.导管维护干预方法 1.1导管维护人员应经过专业理论知识与技能培训。培训由具有资质的肿瘤静疗专科师资护师进行，培训时间为2周，1周理论培训、1周操作培训。具体内容包括但不限于:导管装置的评估、护理；敷料的更换与导管的固定；冲管和封管；附加装置的更换与消毒;穿刺部位的保护;感染的预防与控制；导管拔除；患者健康教育；护理记录；具体培训方法采用理论讲授、小组讨论、操作示教、情景模拟、个案护理等，接受培训后理论、操作考核合格，合格导管维护人员具备识别导管相关并发症的症状和体征的能力可参加本研究。 1.2TIVAP维护封管液选择 2021版 INS指南推荐使用10mL预冲式不含防腐剂生理盐水冲管，100U/mL的肝素生理盐水3-5mL封管。 1.3导管感染控制方法 ①借鉴PICC皮肤消毒方法：以输液港注射座为中心，用75%酒精由内向外，顺时针、逆时针交替螺旋消毒3遍，消毒直径大于20cm；同法用强力碘或洗必泰再消毒一遍。 ②落实血管内导管相关血流感染（CLABSI）集束化管理护理预防，进行感染控制。 1.4改良冲封管手法 使用180°正负恒压冲封管手法，护理人员采用脉冲式技巧冲洗 TIVAP , 脉冲式正压是预防导管堵塞的关键点，为防止导管堵塞，化疗、输血、采血、胃肠外营养后和治疗间歇期等都必须冲管。 ①180°冲管手法：冲管前调整无损伤针，使针的斜面背对输液港港座的导管接口，以脉冲式冲管手法冲洗，这样冲洗液是对着港座的背部而不是直接进入导管口，冲洗效果更好，又可在港座内形成漩涡，把港座内的血液或药液冲洗干净。一手将无损伤针针头沿港座内壁缓慢做180°旋转，另一手持装有生理盐水的注射器边旋转边脉冲式冲管手法冲洗，使生理盐水在注射座内形成漩涡，将附着在港座内及导管壁上的药液充分冲净，直冲3-5mL肝素钠盐水正压封管。 通过不同的冲洗角度，计算各点处的剪切力，从而估计出整体的冲洗效率。 当针尖斜面朝向输液港底部时（α=180°），港座内腔每个面的受力比较均匀，且冲洗力度比较大，冲洗效率最高。 ②冲管频率：每次推注1mL , 分10次间隔1秒。 ③正负恒压手法：按照不同的顺序断开注射器，正压接头在冲管结束后断开注射器，然后夹闭导管；负压接头在冲管液剩余0.5 mL时夹闭导管，再断开注射器；使用恒压无针接头在断开注射器前后夹闭管道。 

Description for medicine or protocol of treatment in detail：

1. Catheter maintenance intervention methods 1.1 Catheter maintenance personnel should undergo professional theoretical knowledge and training. The training is conducted by qualified oncology intravenous therapy specialist nurses. The training lasts for 2 weeks, with 1 week of theoretical training and 1 week of operational training. The specific contents include, but are not limited to: assessment and care of catheter devices; replacement of dressings and fixation of catheters; flushing and sealing of catheters; replacement and disinfection of additional devices; protection of puncture sites; prevention and control of infection; catheter removal; patient health education; nursing records; specific training methods include theoretical lectures, group discussions, operation demonstrations, scenario simulations, case nursing, etc. After passing the theoretical and operational examinations, qualified catheter maintenance personnel have the ability to identify symptoms and signs of catheter-related complications and can participate in this study. 1.2 Selection of maintenance sealing solution for TIVAP The 2021 INS guidelines recommend using 10 mL pre-flushed sterile normal saline for flushing and 3-5 mL of 100 U/mL heparin normal saline for sealing. 1.3 Catheter infection control methods 1 Draw on the PICC skin disinfection method: centered on the infusion port injection seat, use 75% alcohol for spiral disinfection clockwise and counterclockwise alternately for 3 times, with a disinfection diameter greater than 20 cm; the same method uses strong iodine or chlorhexidine for another disinfection. 2 Implement the bundled management nursing for vascular catheter-related bloodstream infection (CLABSI) prevention and control. 1.4 Modified flushing and sealing method Use a 180° positive and negative constant pressure flushing and sealing method. The nursing staff uses pulse technique to rinse the TIVAP. The pulse positive pressure is a key point for preventing catheter blockage. To prevent catheter blockage, flushing is necessary after chemotherapy, blood transfusion, blood collection, parenteral nutrition, and during treatment intervals. 1 180° flushing method: Before flushing, adjust the non-injury needle so that the bevel of the needle faces away from the catheter interface of the infusion port seat. Use the pulse flushing method to rinse, so that the flushing liquid is directed towards the back of the port seat instead of directly entering the catheter opening. The flushing effect is better and a vortex can be formed in the port seat to wash away the blood or drug liquid attached to the port seat and the catheter wall. One hand slowly rotates the non-injury needle along the inner wall of the port seat, and the other hand holds the injection syringe with normal saline and performs the pulse flushing method while rotating to form a vortex in the injection seat, which will flush the drug liquid attached to the port seat and the catheter wall thoroughly. Flush 3-5 mL of heparin sodium salt water under positive pressure for sealing. Through different flushing angles, calculate the shear force at each point to estimate the overall flushing efficiency. When the needle tip bevel faces the bottom of the infusion port (α = 180°), each surface of the port cavity is relatively evenly stressed, and the flushing force is relatively large, resulting in the highest flushing efficiency. 2 Flushing frequency: Inject 1 mL each time, with 10 intervals of 1 second between each injection. 3 Positive and negative pressure method: Disconnect the syringe in a specific order. The positive pressure connector is disconnected from the syringe after the flushing is completed, and then the catheter is clamped; the negative pressure connector is clamped when there is 0.5 mL of flushing liquid remaining, and then the syringe is disconnected; use the constant pressure needle connector to clamp the pipeline before and after disconnecting the syringe. 

纳入标准：

①诊断为各种肿瘤的患者，如头颈部肿瘤、胸部肿瘤、消化道肿瘤、妇科肿瘤等。KPS评分＞80分；②导管维护依从性好，16周间歇期维护使用180°正负压冲封管手法；③输液工具：苏州林华ZS2系列植入式给药装置，型号规格：ZS2-I-J-1.8/1.2-750。

Inclusion criteria

1 Patients diagnosed with various tumors, such as head and neck tumors, thoracic tumors, digestive tract tumors, gynecological tumors, etc. With a KPS score of more than 80; 2 Good compliance with catheter maintenance, using the 180° positive and negative pressure flushing and sealing technique during the 16-week intermittent period; 3 Infusion tools: Suzhou Linhua ZS2 series implantable drug delivery devices, model specification: ZS2-I-J-1.8/1.2-750.

排除标准：

①生存期＜12月；②长期伴有咳嗽、剧烈呕吐症状者；③高凝状态和静脉血栓患者；④排除其他并发症：导管异位、底座翻转。

Exclusion criteria：

1 Survival period less than 12 months; 2 Patients with persistent cough and severe vomiting symptoms; 3 Patients with hypercoagulable state and venous thrombosis; 4 Exclude other complications: catheter malposition, base inversion.

研究实施时间：

Study execute time：

从 From 2025-10-01 00:00:00至 To 2028-10-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-02-01 00:00:00 至 To 2027-02-02 00:00:00  

干预措施：

Interventions：

组别：

对照组

样本量：

113

Group：

Control

Sample size：

干预措施：

传统手法（指南建议）：2021版 INS指南推荐使用10mL预冲式不含防腐剂生理盐水冲管，100U/mL的肝素生理盐水3-5mL封管。

干预措施代码：

Intervention：

Traditional approach (as recommended by the guidelines): The 2021 version of the INS guidelines recommends using 10 mL of pre-filled non-antibacterial normal saline for flushing the tube, and 3-5 mL of 100 U/mL heparin normal saline for sealing the tube.

Intervention code：

组别：

实验组

样本量：

113

Group：

Experimental

Sample size：

干预措施：

改良冲封管手法：使用180°正负恒压冲封管手法，护理人员采用脉冲式技巧冲洗 TIVAP , 脉冲式正压是预防导管堵塞的关键点，为防止导管堵塞，化疗、输血、采血、胃肠外营养后和治疗间歇期等都必须冲管。 ①180°冲管手法：冲管前调整无损伤针，使针的斜面背对输液港港座的导管接口，以脉冲式冲管手法冲洗，这样冲洗液是对着港座的背部而不是直接进入导管口，冲洗效果更好，又可在港座内形成漩涡，把港座内的血液或药液冲洗干净。一手将无损伤针针头沿港座内壁缓慢做180°旋转，另一手持装有生理盐水的注射器边旋转边脉冲式冲管手法冲洗，使生理盐水在注射座内形成漩涡，将附着在港座内及导管壁上的药液充分冲净，直冲3-5mL肝素钠盐水正压封管。 通过不同的冲洗角度，计算各点处的剪切力，从而估计出整体的冲洗效率。 当针尖斜面朝向输液港底部时（α=180°），港座内腔每个面的受力比较均匀，且冲洗力度比较大，冲洗效率最高。 ②冲管频率：每次推注1mL , 分10次间隔1秒。 ③正负恒压手法：按照不同的顺序断开注射器，正压接头在冲管结束后断开注射器，然后夹闭导管；负压接头在冲管液剩余0.5 mL时夹闭导管，再断开注射器；使用恒压无针接头在断开注射器前后夹闭管道。

干预措施代码：

Intervention：

Improved catheter sealing technique: Use a 180° positive and negative constant pressure catheter sealing technique. Nursing staff use pulse-style techniques to flush the TIVAP. The pulse-style positive pressure is a key point in preventing catheter blockage. To prevent catheter blockage, flushing is necessary after chemotherapy, blood transfusion, blood collection, parenteral nutrition, and during treatment intervals. ① 180° catheter sealing technique: Before flushing, adjust the non-invasive needle so that the bevel of the needle faces away from the catheter interface of the infusion port. Use the pulse-style catheter sealing technique to flush, so that the flushing fluid is directed towards the back of the port seat instead of directly entering the catheter opening. This results in better flushing effect and can form a vortex in the port seat to wash away the blood or drug in the port seat and the catheter wall.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 新疆 

市(区县)：

 伊宁 

Country：

China 

Province：

xinjiang 

City：

 

单位(医院)：

新疆维吾尔自治区伊犁哈萨克自治州友谊医院 

单位级别：

三甲 

Institution
hospital：

The Science and Technology Ethics Committee of Friendship Hospital of Yili Kazakh Autonomous Prefecture

Level of the institution：

Grade A Three

测量指标：

Outcomes：

指标中文名：

感染相关评价指标

指标类型：

主要指标

Outcome：

Infection-related evaluation indicators

Type：

Primary indicator

测量时间点：

每次随访时

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

导管堵塞相关评价指标

指标类型：

主要指标

Outcome：

Evaluation indicators related to catheter blockage

Type：

Primary indicator

测量时间点：

每次随访时

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

血栓相关评价指标

指标类型：

次要指标

Outcome：

Thrombus-related evaluation indicators

Type：

Secondary indicator

测量时间点：

每次随访时

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：

血液

组织：

/

Sample Name：

Blood

Tissue：

/

人体标本去向

 使用后销毁  

说明

/

Fate of sample：

Destruction after use  

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 100 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）：

本研究负责人于云副主任护师带领研究团队，采用SPSS 26.0统计软件生成随机序列，通过密封信封法进行随机分组

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

The principal investigator, Deputy Chief Nurse Yu Yun, led the research team and used SPSS 26.0 statistical software to generate a random sequence. They then used the sealed envelope method to conduct random grouping.

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：

由研究负责人于云副主任护师通过 SPSS 26.0 统计软件生成随机序列后，将每组分配结果对应写入独立密封信封，信封标注唯一编号（无分组信息）并密封保存，交由非研究执行人员（医院伦理委员会指定专员）统一管理。 研究入组时，由负责招募的医护人员仅根据患者入院顺序，到伦理专员处领取对应编号的密封信封，当场拆封确认分组，再将患者分配至对应组别接受干预。研究执行医护人员、随访人员及受试者均不知晓随机序列生成规则及分组对应关系，仅伦理专员掌握完整分组信息，直至研究观察期结束、数据锁定后才揭盲，确保分组隐蔽性与研究客观性。

Blinding：

After the research leader, Deputy Chief Nurse Yu Yun, generated the random sequence using SPSS 26.0 statistical software, the allocation results of each group were written into separate sealed envelopes. The envelopes were labeled with unique numbers (without group information) and sealed for storage. They were then handed over to non-research personnel (designated specialists by the hospital ethics committee) for unified management. When the research participants were enrolled, the recruiting medical staff only collected the sealed envelopes with corresponding numbers from the ethics committee specialist based on the order of patient admission. They opened and confirmed the groups on the spot, and then assigned the patients to the corresponding groups for intervention. The research execution medical staff, follow-up personnel, and participants were all unaware of the random sequence generation rules and the corresponding group relationships. Only the ethics committee specialist had complete group information. The blinding was not disclosed until the end of the research observation period and data locking, ensuring the concealment of the groups and the objectivity of the research.

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）：

通过网络平台公开，具体为中国临床试验注册中心（ChiCTR），网址：http://www.chictr.org.cn，同步上传至国家医学研究登记备案信息系统；

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

ChiCTR:http://www.chictr.org.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：

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：

EDC

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：

  2026-01-28 15:38:40