ChiCTR2100046899 版本V1.2 版本创建时间2021/05/30 01:00:50 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：

ChiCTR2100046899 

最近更新日期：

Date of Last Refreshed on：

2021-05-30 00:59:56 

注册时间：

Date of Registration：

2021-05-30 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

改良短轴联合长轴法与斜轴法在成人右颈内静脉置管中的疗效和安全性比较:一项单中心、前瞻性、随机对照、非劣效性、平行设计对照临床试验

Public title：

Compare the Efficacy and Safety of Modified Combined Short and Long Axis method versus Oblique Axis method for Right Internal Jugular Vein Catheterization in Adult Patients: a single-center, prospective, randomized parallel controlled, non-inferiority design trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

超声引导中心静脉置管:改良短轴联合长轴法与斜轴法:单中心、前瞻性、随机对照、非劣效性、平行设计临床研究

Scientific title：

Ultrasound-guided central venous catheterization -modified combined short and long axis method versus oblique axis: a single-center, prospective, randomized parallel controlled, non-inferiority design trial

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：

唐家喜 

研究负责人：

唐家喜 

Applicant：

Jiaxi Tang 

Study leader：

Jiaxi Tang 

申请注册联系人电话：

Applicant telephone：

+86 13883017049

研究负责人电话：

Study leader's telephone：

+86 13883017049

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：

tangjiaxi1029@126.com

研究负责人电子邮件：

Study leader's E-mail：

tangjiaxi1029@126.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

https://www.cqch.cn/

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：

重庆市沙坪坝区汉渝路181号

研究负责人通讯地址：

重庆市沙坪坝区汉渝路181号

Applicant address：

181 Hanyu Road, Shapingba District, Chongqing, China

Study leader's address：

181 Hanyu Road, Shapingba District, Chongqing, China

申请注册联系人邮政编码：

Applicant postcode：

400030

研究负责人邮政编码：

Study leader's postcode：

400030

申请人所在单位：

重庆大学附属肿瘤医院

Applicant's institution：

Chongqing University Cancer Hospital

研究负责人所在单位：

重庆大学附属肿瘤医院

Affiliation of the Leader：

Chongqing University Cancer Hospital

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：

CZLS2021042-A

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：

重庆大学附属肿瘤医院伦理委员会

Name of the ethic committee：

Ethics Committee of Chongqing University Cancer Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2021-02-04 00:00:00

伦理委员会联系人：

汤晓华

Contact Name of the ethic committee：

Xiaohua Tang

伦理委员会联系地址：

重庆市沙坪坝区汉渝路181号

Contact Address of the ethic committee：

181 Hanyu Road, Shapingba District, Chongqing, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 18225012240

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：

重庆大学附属肿瘤医院

Primary sponsor：

Chongqing University Cancer Hospital

研究实施负责（组长）单位地址：

重庆市沙坪坝区汉渝路181号

Primary sponsor's address：

181 Hanyu Road, Shapingba District, Chongqing, 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)：

重庆

市(区县)：

Country：

China

Province：

Chongqing

City：

单位(医院)：

重庆大学附属肿瘤医院

具体地址：

沙坪坝区汉渝路181号

Institution
hospital：

Chongqing University Cancer Hospital

Address：

181 Hanyu Road, Shapingba District

经费或物资来源：

重庆市科卫联合医学科研项目 面上项目

Source(s) of funding：

General project of the joint medical scientific research project of Chongqing Science and Technology Bureau and Health Bureau

Target disease：

Central venipucture and catheterization

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 治疗新技术临床试验 

Study phase：

New Treatment Measure Clinical Study

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

通过比较改良短轴联合长轴法和斜轴法穿刺指标的差异，明确成年患者最佳超声引导 IJV 穿刺方法。  

Objectives of Study：

By comparing the difference in the puncture indexes of the Modified combined short and long axis method and the oblique axis method, the best ultrasound-guided IJV puncture method for adult patients was determined.

药物成份或治疗方案详述：

临床试验分为两组，分别行改良短轴法联合长轴法（M组）和斜轴法（O组）穿刺。首先常规消毒，铺无菌洞巾，将超声探头放进无菌保护套，往保护套内注入 10 ml 无菌超声耦合剂，固定好探头套，其中改良短轴法超声探头提前在探头中心线位置固定不透射线的双缝线，双缝线间距为10mm。两组操作方法如下： M 组（改良短轴联合长轴法）：M 组（改良短轴联合长轴法）：首先将超声探头纵向放置，确认穿刺针进针平面，然后将超声探头横向放置，超声探头 Mark 点朝向患者内侧，可以观察到 IJV 和CCA 的短轴视图。调节探头左右位置，使探头双缝线的声学阴影正好落在IJV的正上方，穿刺针从探头双缝线中点平面外进针，在超声屏幕上见一高回声亮点时停止进针，将超声探头顺时针旋转90°，即可见IJV的长轴切面及穿刺针针体，超声引导下进针，当在超声图像中看到针尖刺破血管前壁并有暗红色血液回流通畅至针筒，停止进针，停止超声探查，置入导丝，超声短轴再次确认导丝位置正确，置入中心静脉导管，回抽有暗红色血液确认中心静脉导管放置在颈内静脉，固定导管，覆盖无菌透明敷贴。 O 组（斜轴法）：将超声探头横向放置在右侧胸锁乳突肌三角（胸锁乳突肌下端锁骨头、胸骨头与锁骨上缘构成的三角）的顶点处（与锁骨平行），探头的 Mark 点朝向患者内侧，可以观察到 IJV 和 CCA 的短轴视图。随后将探头顺时针旋转 45°，使探头的 Mark 点在近心端朝向患者对侧乳头，即获得 IJV 斜轴平面，穿刺针从探头外侧 0.5～1 cm 平面内进针，穿刺过程中实时观察穿刺针进程，当在超声图像中看到针尖刺破血管壁并有暗红色血液回流通畅至针筒，停止进针，停止超声探查，置入导丝，超声短轴再次确认导丝位置正确，置入中心静脉导管，回抽有暗红色血液确认中心静脉导管放置在颈内静脉，固定导管，覆盖无菌透明敷贴。 

Description for medicine or protocol of treatment in detail：

The clinical trial is divided into two groups, including Modified combined short and long axis method (M group) puncture group and oblique axis method (O group) puncture group. First, perform routine disinfection, spread a sterile hole towel, put the ultrasound probe into a sterile protective cover, inject 10 ml of sterile ultrasound couplant into the protective cover, and fix the probe cover. In the M group, a braided silk suture is tied parallelly (interval: 10 mm) on the ultrasound probe and positions perpendicular to the long axis of the probe in advance. The two operating methods are as follows: Group M: Firstly, the ultrasonic probe was placed longitudinally to confirm that the puncture needle entered the needle plane. Then, the ultrasonic probe was placed laterally with the ultrasonic probe Mark point toward the inner side of the patient, and the short-axis view of IJV and CCA could be observed. Adjust the probe position, make the probe double stitching acoustic shadow fell in IJV, needle from the neutral plane into needle probe double stitching, see high echo in ultrasonic screen window stops into the needle, the ultrasonic probe clockwise rotate 90 °, i.e. the long axis section of IJV and needle puncture needle body, under the guidance of ultrasound into the needle, When see the pin prick blood vessels in ultrasonic image front wall and a dark red blood reflux flow to the cylinder, stop into the needle, stop the ultrasonic probe, placing godet, ultrasound confirmed short axis thread position right, central venous catheter placement, smoke has dark red blood back to confirm central venous catheter placed in the internal jugular vein, fixed catheter, cover sterile transparent patches. Group O: Place the ultrasound probe horizontally at the apex of the right sternocleidomastoid muscle triangle (the lower end of the sternocleidomastoid muscle, the triangle formed by the sternum head and the upper edge of the clavicle) (parallel to the clavicle), the Mark point of the probe Towards the inside of the patient, a short-axis view of IJV and CCA can be observed. Then rotate the probe clockwise by 45° so that the Mark point of the probe faces the patient's contralateral nipple at the proximal end, and the IJV oblique axis plane is obtained. The puncture needle is inserted in the 0.5-1 cm outside of the probe by using In-plane technology, and the puncture process is observed in real time. During the puncture needle process, when it is seen in the ultrasound image that the needle tip punctures the blood vessel wall and there is dark red blood flowing back to the syringe barrel, stop inserting the needle, insert the guide wire, and the ultrasound short axis to confirm the position of the guide wire again. The central venous catheter is inserted, and dark red blood is drawn back to confirm that the central venous catheter is placed in the internal jugular vein. The catheter is fixed and covered with a sterile transparent dressing. 

纳入标准：

1.就诊于我院，拟全麻下行择期手术、需行右侧IJV 穿刺置管术的患者；2.年龄18-75岁；3.签署知情同意书。

Inclusion criteria

1. Patients in our hospital who plan to undergo elective surgery under general anesthesia and need to undergo right IJV catheterization;
2. Aged 18 to 75 years old;
3. Sign informed consent.

排除标准：

1.凝血功能异常；2.穿刺部位感染；3.ASA分级>III级；4. 颈部瘢痕；5. 气管切开史；6.一月内右IJV 置管史；7. 颈部外伤史患者；8. 颈椎手术史患者；9. 颈部手术或放疗史患者；10. 右颈部巨大肿块或淋巴结；11.存在血液系统疾病者；12. 精神性疾病患者；13. 解剖变异，无右 IJV 者；14. IJV 斑块血栓形成；15. 超声显像不清晰者；16. BMI> 40Kg/M2；17.患者拒绝参加。

Exclusion criteria：

1. Abnormal coagulation function; 2. Puncture site infection; 3.ASA classification > Grade III; 4. Scar on the neck; 5. Tracheotomy history; 6. Right IJV catheterization history within one month; 7. Patients with a history of neck trauma; 8. Patients with a history of cervical spine surgery; 9. Patients with a history of neck surgery or radiotherapy; 10. Large mass or lymph node in the right neck; 11. Patients with diseases of the blood system; 12. Patients with mental diseases; 13. Anatomic variation without right IJV; 14. IJV plaque thrombosis; 15. Unclear ultrasound imaging; 16. The BMI > 40 kg/M2; 17. Patients refuse to participate.

研究实施时间：

Study execute time：

从 From 2020-12-31 00:00:00至 To 2021-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2020-12-31 00:00:00 至 To 2021-12-31 00:00:00  

干预措施：

Interventions：

组别：

M组

样本量：

94

Group：

Group M

Sample size：

干预措施：

改良短轴联合长轴法超声引导右颈内静脉穿刺置管

干预措施代码：

Intervention：

Modified combined short and long axis ultrasound guided right jugular vein puncture catheterization

Intervention code：

组别：

O组

样本量：

94

Group：

Group O

Sample size：

干预措施：

斜轴法超声引导右颈内静脉穿刺置管

干预措施代码：

Intervention：

Oblique axis ultrasound guided right jugular vein puncture catheterization

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 重庆 

市(区县)：

  

Country：

China 

Province：

Chongqing 

City：

 

单位(医院)：

重庆大学附属肿瘤医院 

单位级别：

三甲 

Institution
hospital：

Chongqing University Cancer Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

无后壁穿透一次成功率

指标类型：

主要指标

Outcome：

One-time success rate of puncture without posterior wall puncture

Type：

Primary indicator

测量时间点：

IJV穿刺操作过程中

测量方法：

Measure time point of outcome：

During the IJV puncture process

Measure method：

指标中文名：

短轴平面和斜轴平面下 IJV 横径/纵径

指标类型：

次要指标

Outcome：

The transverse/longitudinal diameters of IJV under the short and oblique planes

Type：

Secondary indicator

测量时间点：

IJV穿刺前

测量方法：

在短轴平面和斜轴平面测量同一患者IJV横径/纵径，精确到小数的后一位，单位为毫米(mm)

Measure time point of outcome：

Before IJV puncture

Measure method：

The transverse diameter of IJV of the same patient was measured on the short-axis plane and the oblique plane, accurate to accurate to one decimal place ,and the measurement index unit is millimeters

指标中文名：

CCA 与 IJV 重叠率

指标类型：

次要指标

Outcome：

CCA and IJV overlap rate

Type：

Secondary indicator

测量时间点：

IJV穿刺前

测量方法：

短轴平面和斜轴平面测量同一患者IJV 与 CCA 重叠距离和IJV横径，并计算：IJV 与 CCA 重叠率（%）=[IJV 与 CCA 重叠距离/IJV 横径]×100%

Measure time point of outcome：

Before IJV puncture

Measure method：

The overlap distance between IJV and CCA and the transverse diameter of IJV of the same patient were measured on the short-axis plane and the oblique axis plane, and the overlap rate (%) =[the overlap distance between IJV and CCA/the transverse diameter of IJV]×100% were calculated

指标中文名：

IJV安全穿刺距离

指标类型：

次要指标

Outcome：

IJV safe puncture distance

Type：

Secondary indicator

测量时间点：

IJV穿刺前

测量方法：

Measure time point of outcome：

Before IJV puncture

Measure method：

指标中文名：

穿刺次数

指标类型：

次要指标

Outcome：

Number of punctures

Type：

Secondary indicator

测量时间点：

IJV穿刺操作过程中

测量方法：

记录总的穿刺次数，单位为次

Measure time point of outcome：

During the IJV puncture process

Measure method：

The total number of puncture was recorded in units of times

指标中文名：

总穿刺成功率

指标类型：

次要指标

Outcome：

Total puncture success rate

Type：

Secondary indicator

测量时间点：

IJV穿刺操作过程中

测量方法：

记录两种穿刺方法总的穿刺成功患者数目，分别计算总的穿刺成功率，总穿刺成功率（%）=[总穿刺成功患者数/总的穿刺患者数]×100%

Measure time point of outcome：

During the IJV puncture process

Measure method：

The total number of successful patients of the two puncture methods was recorded, and the total puncture success rate was calculated respectively. The total puncture success rate (%) =[the total number of successful patients/the total number of puncture patients]×100%

指标中文名：

IJV 后壁穿透(PVWP)数和率

指标类型：

副作用指标

Outcome：

IJV posterior wall penetration (PVWP) number and rate

Type：

Adverse events

测量时间点：

IJV穿刺操作过程中

测量方法：

记录两种穿刺方法IJV后壁穿透患者数目，分别计算两种方法颈内静脉PVWP率，PVWP率（%）=[PVWP患者数/总的穿刺患者数]×100%

Measure time point of outcome：

During the IJV puncture process

Measure method：

During the process, the number of patients with PVWP of the two puncture methods for IJV was recorded, and the PVWP rates of the two methods were calculated respectively. The PVWP rate (%) =[number of PVWP patients/total number of puncture patients]×100%

指标中文名：

血肿发生数和率

指标类型：

副作用指标

Outcome：

Number and rate of hematoma

Type：

Adverse events

测量时间点：

IJV穿刺结束后即刻和穿刺后1天、3天

测量方法：

记录两种方法血肿发生数，分别计算两种方法血肿发生率，血肿发生率（%）=[发生血肿患者数/总的穿刺患者数]×100%

Measure time point of outcome：

Immediate, 1d and 3 d after the puncture

Measure method：

The incidence of hematoma in the two methods was recorded, and the incidence of hematoma in the two methods was calculated respectively. The incidence of hematoma (%) =[number of patients with hematoma occurring/total number of patients undergoing puncture]×100%

指标中文名：

误穿动脉发生数和率

指标类型：

副作用指标

Outcome：

Number and rate of accidental artery penetration

Type：

Adverse events

测量时间点：

IJV穿刺过程中

测量方法：

记录两种穿刺方法IJV穿刺过程中误穿动脉患者数目，分别计算两种方法误穿动脉发生率，误穿动脉发生率（%）=[误穿动脉患者数/总的穿刺患者数]×100%

Measure time point of outcome：

During the IJV puncture process

Measure method：

The number of patients with artery puncture during the two puncture methods IJV were recorded, and the incidence of artery puncture was calculated respectively. The incidence of artery puncture (%) =[number of patients with artery puncture/total number of puncture patients]×100%

指标中文名：

气胸发生数和率

指标类型：

副作用指标

Outcome：

Number and rate of pneumothorax

Type：

Adverse events

测量时间点：

IJV穿刺过程中和穿刺结束后1天、3天

测量方法：

记录两种穿刺方法IJV穿刺过程中气胸发生数目，分别计算两种方法气胸发生率，气胸发生率（%）=[发生气胸患者数/总的穿刺患者数]×100%

Measure time point of outcome：

During the IJV puncture process, 1d and 3 days after the puncture

Measure method：

The number of pneumothorax occurred during the puncture process of IJV by the two puncture methods was recorded, and the incidence of pneumothorax by the two methods was calculated respectively. The incidence of pneumothorax (%) =[number of patients with pneumothorax/total number of puncture patients]×100%

指标中文名：

血胸发生数和率

指标类型：

副作用指标

Outcome：

Number and rate of hemothorax

Type：

Adverse events

测量时间点：

IJV穿刺结束后即可，穿刺结束后1天、3天

测量方法：

记录两种穿刺方法IJV穿刺过程中血胸发生数目，分别计算两种方法血胸发生率，血胸发生率（%）=[发生血胸患者数/总的穿刺患者数]×100%

Measure time point of outcome：

Immediate, 1d and 3 d after the puncture

Measure method：

The number of hemothorax in the process of the two puncture methods IJV was recorded, and the incidence of hemothorax in the two methods was calculated respectively. The incidence of hemothorax in the two methods (%) =[number of patients with hemothorax/total number of puncture patients]×100%

指标中文名：

刺入 IJV 时间

指标类型：

次要指标

Outcome：

Puncture time

Type：

Secondary indicator

测量时间点：

IJV穿刺过程中

测量方法：

IJV穿刺操作过程中使用进过校正的秒表记录从进针开始到超声确认导丝在 IJV 内，并且位置正确的时间，精确到小数的后一位，单位为秒（s）。

Measure time point of outcome：

During the IJV puncture process

Measure method：

During the IJV puncture operation, a corrected stopwatch is used to record the time from the insertion of the needle to the ultrasonic confirmation that the guide wire is within the IJV and in the correct position, accurate to the last decimal place in seconds (s).

指标中文名：

定位时间

指标类型：

次要指标

Outcome：

Positioning time

Type：

Secondary indicator

测量时间点：

IJV穿刺过程中

测量方法：

IJV穿刺操作过程中使用进过校正的秒表进行记录超声探头接触患者皮肤，到开始穿刺的时间，精确到小数的后一位，单位为秒（s）。

Measure time point of outcome：

During the IJV puncture process

Measure method：

During the IJV puncture operation, a corrected stopwatch was used to record the time from the ultrasonic probe's contact with the patient's skin to the beginning of the puncture, accurate to the last decimal place, in seconds (s).

指标中文名：

总的穿刺时间

指标类型：

次要指标

Outcome：

Total puncture time

Type：

Secondary indicator

测量时间点：

IJV穿刺过程中

测量方法：

IJV穿刺操作过程中使用进过校正的秒表进行记录，从进针开始到导管置入正确，贴好敷贴的时间，精确到小数的后一位，单位为秒（s）。

Measure time point of outcome：

During the IJV puncture process

Measure method：

During the IJV puncture operation, a corrected stopwatch was used to record the time from needle insertion until the catheter was placed correctly and the application was applied to the last decimal place, in seconds (s).

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：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 75 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）：

采用区组随机法，区组数为4，电脑产生随机数字表分组，由不参与临床研究的统计学家产生随机数字表

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

Blocks of 4 randomization is used to assign participants to intervention arms, with 1:1 allocation ratio. Computer-generated randomization sequence was created and is maintained by the study biostatistician.

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：

为增加研究结果及由此推论所得结论的可靠性，在综合衡量研究的可行性基础上，随机数字表封存于非透明信封，由不参与本实验的专职人员保管。由于操作本身特点，操作者无法实施盲法，本研究对患者及参与数据记录、整理及统计分析人员采用盲法。

Blinding：

In order to increase the reliability of the study results and conclusions, based on the feasibility of the comprehensive measurement study, the random number table was sealed in an opaque envelope and kept by full-time personnel who did not participate in the study.Due to the characteristics of the operation itself, the operator could not implement the blind method, so the patients and the personnel involved in data recording, sorting and statistical analysis were blinded in this study

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）：

试验完成后6个月内公开原始数据。上传到ResMan临床试验公共管理平台，平台网址：http://www.medresman.org

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

Raw data will be made public within 6 months after completion of the trial. Uplifies to the Resman Clinical Trials Public Administration Platform at http://www.medresman.org

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：

采样病例记录表采集数据，采用EXCEL表管理数据。

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

Data were collected in case record Form and Excel table was used to manage data.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2021-05-30 00:48:40