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

Shandong Branden Med.Device

Status: Unknown

Conditions: Peripherally Inserted Central Catheter

Treatments: Device: PICC guided by EDUG

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03230357

Branden-edug

Details and patient eligibility

About

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)

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,000 participants in 1 patient group

PICC guided by EDUG

Experimental group

Description:

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.

Treatment:

Device: PICC guided by EDUG