- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03230357
Research on the Localization Accuracy of PICC Guided by EDUG in Real World
July 25, 2017 updated by: Shandong Branden Med.Device Co.,Ltd
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
1000
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Shandong
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Jinan, Shandong, China
- Qilu Hospital of Shangdong University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- 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.
Exclusion Criteria:
- 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
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
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.
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the rate of once in place
Time Frame: From the date of admitting to hospital until completion of the trial, up to 6 months.
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judge weather the catheter tip location guided by the EDUG is accuracy by compare the results with the Xray
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From the date of admitting to hospital until completion of the trial, up to 6 months.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the number of adjustment times before X-ray
Time Frame: From the date of admitting until discharge to hospital, up to 14 days.
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the totally number of adjustment times during the once operation guided by EDUG
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From the date of admitting until discharge to hospital, up to 14 days.
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the length of time during the whole catheter placement before X-ray
Time Frame: From the date of admitting until discharge to hospital, up to 14 days.
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the whole length of time during the once operation guided by EDUG
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From the date of admitting until discharge to hospital, up to 14 days.
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the number of cathetering times after X-ray
Time Frame: From the date of admitting until discharge to hospital, up to 14 days.
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the totally number of cathetering times during the operation guided by EDUG until the cather tip can be guided to the right location
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From the date of admitting until discharge to hospital, up to 14 days.
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record the adverse events
Time Frame: 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
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the adverse events including bleeding, infection , thrombosis and so on
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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
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Patient acceptance
Time Frame: From the date of admitting until discharge to hospital, up to 14 days.
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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
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From the date of admitting until discharge to hospital, up to 14 days.
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the convenience of the operation
Time Frame: From the date of admitting until discharge to hospital, up to 14 days.
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App questionnaire was used to collect the convenience and comfort of PICC operators
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From the date of admitting until discharge to hospital, up to 14 days.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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