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

NCT03230357 | Unknown DMC

• 1 other identifier: Branden-edug
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• the number of adjustment times before X-ray

  From the date of admitting until discharge to hospital, up to 14 days.

• the length of time during the whole catheter placement before X-ray

  From the date of admitting until discharge to hospital, up to 14 days.

• the number of cathetering times after X-ray

  From the date of admitting until discharge to hospital, up to 14 days.

• record the adverse events

  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

• Patient acceptance

  From the date of admitting until discharge to hospital, up to 14 days.

Study Arms (1)

PICC guided by EDUG

EXPERIMENTAL

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.

Device: PICC guided by EDUG

Interventions

PICC guided by EDUG 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

PICC guided by EDUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient≥18 years old
• Follow the doctor's advice,patients who need to be placed PICC for the first time.
• No serious cardiovascular diseases, such as atrial fibrillation,pulmonary heart disease and other P wave abnormalities, severe heart block, etc.
• Patients who did not participate in other clinical studies；
• Patients who volunteer to participate the clinical study, sign the informed consent and cooperate with the clinical follow-up.

You may not qualify if:

• Patients who have partial deformity or scar formation
• Patients whose puncture site were infected or damaged
• Patients who have sclerosis or the cord like change of the vein
• Patients have compressed vessel by tumor
• Patients who are confirmed or suspected having infection, bacteremia, or sepsis related to the catheter
• Patients whose size are not fit to insert the PICC
• Patients who are confirmed or suspected sensitive to silica gel
• Patients who have history of radiotherapy in the pre-insertion section
• Patients who have history of venous thrombosis, trauma, or vascular surgery
• Patients who have superior vena cava syndrome
• Patients who were always not following up with the doctors
• Patients who have severe peripheral edema
• Patients who may be required a high flow of fluid infusion, hemodialysis, pacemaker, crutches or A-V fistulation

Sponsors & Collaborators

• Shandong Branden Med.Device Co.,Ltd: lead
• Qilu Hospital of Shandong University: collaborator

Study Sites (1)

Qilu Hospital Of Shangdong University

Jinan, Shandong, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2017
• First Posted: July 26, 2017
• Study Start: May 2, 2017
• Primary Completion: February 2, 2018
• Study Completion: August 2, 2018
• Last Updated: July 26, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)