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

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)

Study Overview

• Status: Unknown
• Conditions: Peripherally Inserted Central Catheter
• Intervention / Treatment: Device: PICC guided by EDUG

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China
      • Qilu Hospital of Shangdong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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
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.
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.

Collaborators and Investigators

• Sponsor: Shandong Branden Med.Device Co.,Ltd
• Collaborators: Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 2, 2017
• Primary Completion (ANTICIPATED): February 2, 2018
• Study Completion (ANTICIPATED): August 2, 2018

Study Registration Dates

• First Submitted: July 10, 2017
• First Submitted That Met QC Criteria: July 25, 2017
• First Posted (ACTUAL): July 26, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2017
• Last Update Submitted That Met QC Criteria: July 25, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: Branden-edug

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No