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

Peripherally Inserted Central Catheter Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03230357
• Other study ID #: Branden-edug
• Status: Active, not recruiting
• Phase: N/A
• First received: July 10, 2017
• Last updated: July 25, 2017
• Start date: May 2, 2017
• Est. completion date: August 2, 2018

Study information

• Verified date: July 2017
• Source: Shandong Branden Med.Device Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: August 2, 2018
• Est. primary completion date: February 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripherally Inserted Central Catheter

Intervention

Device:
• 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

Locations

Country	Name	City	State
China	Qilu Hospital Of Shangdong University	Jinan	Shandong

Sponsors (2)

Lead Sponsor	Collaborator
Shandong Branden Med.Device Co.,Ltd	Qilu Hospital Of Shandong Univrsity

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the rate of once in place	judge weather the catheter tip location guided by the EDUG is accuracy by compare the results with the Xray	From the date of admitting to hospital until completion of the trial, up to 6 months.
Secondary	the number of adjustment times before X-ray	the totally number of adjustment times during the once operation guided by EDUG	From the date of admitting until discharge to hospital, up to 14 days.
Secondary	the length of time during the whole catheter placement before X-ray	the whole length of time during the once operation guided by EDUG	From the date of admitting until discharge to hospital, up to 14 days.
Secondary	the number of cathetering times after X-ray	the totally number of cathetering times during the operation guided by EDUG until the cather tip can be guided to the right location	From the date of admitting until discharge to hospital, up to 14 days.
Secondary	record the adverse events	the adverse events including bleeding, infection , thrombosis and so on	0,24,48,72 hours and 7days after completing the whole cathetering operation; Every 7 days from completing the whole cathering operation until tube drawing whichever came first, assessed up to 1 year
Secondary	Patient acceptance	The patient who is in line with the discharge criteria and intends to enter the study shall record whether or not he has agreed to accept the operation plan and complete the operation	From the date of admitting until discharge to hospital, up to 14 days.
Secondary	the convenience of the operation	App questionnaire was used to collect the convenience and comfort of PICC operators	From the date of admitting until discharge to hospital, up to 14 days.