Clinical trial NCT03230357: Research on the Localization Accuracy of PICC Guided by EDUG in Real World
Official title: Research on the Localization Accuracy of PICC Guided by EDUG in Real World
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripherally Inserted Central Catheter
Lead sponsor: Shandong Branden Med.Device Co.,Ltd
Sponsor class: INDUSTRY
Collaborators: name: Qilu Hospital of Shandong University
First posted: 2017-07-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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)


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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Primary outcomes:
measure: the rate of once in place
timeFrame: From the date of admitting to hospital until completion of the trial, up to 6 months.
Secondary outcomes:
measure: the number of adjustment times before X-ray
timeFrame: From the date of admitting until discharge to hospital, up to 14 days.
measure: the length of time during the whole catheter placement before X-ray
timeFrame: From the date of admitting until discharge to hospital, up to 14 days.
measure: the number of cathetering times after X-ray
timeFrame: From the date of admitting until discharge to hospital, up to 14 days.
measure: record the adverse events
timeFrame: 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
measure: Patient acceptance
timeFrame: From the date of admitting until discharge to hospital, up to 14 days.
measure: the convenience of the operation
timeFrame: From the date of admitting until discharge to hospital, up to 14 days.
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital Of Shangdong University
state: Shandong
Study officials:
References: