Research on the Localization Accuracy of PICC Guided by EDUG in Real World

NCT ID: NCT03230357

Last Updated: 2017-07-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-02
• Study Completion Date: 2018-08-02

Brief Summary

This study is a multi-center clinical study, 3000 cases, 25 centers in the country involved, carry out the guidance of EDUG PICC standardized operation at the same period. Each center assists to use app to collect research data.The experimental data will be collected, processed and analyzed by the sponsor and the researchers, and the clinical effect of EDUG will be evaluated according to the results (like the rate of once in place, the number of adjustment times before X-ray, the length of time during the whole catheter placement, the ectopic incidence during PICC first implantation and so on, the special content can be seen in the next indicator section)

Conditions

Peripherally Inserted Central Catheter

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

PICC guided by EDUG

PICC(Peripherally Inserted Central Catheter)guided by ECG Doppler ultrasonic Guidance（EDUG),EDUG is a combination device which can be used for selecting the right vein and precise positioning for the catheter tip during the PICC cathetering.

Group Type: EXPERIMENTAL

PICC guided by EDUG

Intervention Type: DEVICE

ECG Doppler ultrasound guidance technology (EDUG) is the combination of MST puncture and ECG technology through the use of ECG Doppler ultrasound machine and valve conduction PICC to conform the localization of EDUG technology by the study of real-world

Interventions

PICC guided by EDUG

ECG Doppler ultrasound guidance technology (EDUG) is the combination of MST puncture and ECG technology through the use of ECG Doppler ultrasound machine and valve conduction PICC to conform the localization of EDUG technology by the study of real-world

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patient≥18 years old

2. Follow the doctor's advice,patients who need to be placed PICC for the first time.

3. No serious cardiovascular diseases, such as atrial fibrillation,pulmonary heart disease and other P wave abnormalities, severe heart block, etc.

4. Patients who did not participate in other clinical studies；

5. Patients who volunteer to participate the clinical study, sign the informed consent and cooperate with the clinical follow-up.

Exclusion Criteria

1. Patients who have partial deformity or scar formation

2. Patients whose puncture site were infected or damaged

3. Patients who have sclerosis or the cord like change of the vein

4. Patients have compressed vessel by tumor

5. Patients who are confirmed or suspected having infection, bacteremia, or sepsis related to the catheter

6. Patients whose size are not fit to insert the PICC

7. Patients who are confirmed or suspected sensitive to silica gel

8. Patients who have history of radiotherapy in the pre-insertion section

9. Patients who have history of venous thrombosis, trauma, or vascular surgery

10. Patients who have superior vena cava syndrome

11. Patients who were always not following up with the doctors

12. Patients who have severe peripheral edema

13. Patients who may be required a high flow of fluid infusion, hemodialysis, pacemaker, crutches or A-V fistulation

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• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Hospital of Shandong University

OTHER

Sponsor Role: collaborator

Shandong Branden Med.Device Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Qilu Hospital Of Shangdong University

Jinan, Shandong, China

Countries

China

Other Identifiers

Branden-edug

Identifier Type: -

Identifier Source: org_study_id