Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT02409589 |
Other study ID # |
2015-001 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
March 2015 |
Est. completion date |
October 2015 |
Study information
Verified date |
April 2022 |
Source |
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to compare a new intracavitary ECG guiding method for real-time
positioning the tip of three-way valve type peripherally inserted central catheters versus
conventional surface prediction length method in terms of single-time target rate.
Description:
The use of peripherally inserted central catheters (PICCs) has increased significantly for
cancer patients receiving chemotherapy. For these patients, PICCs afford many advantages with
regards to complications and treatment convenience.
Current practice utilizes the estimated length of the catheter from puncture site to the
junction of superior vena cava / right atrium (SVC-RA) for guiding tip placement. Next the
catheter tip placement was confirmed by radiographic imaging prior to use of the line for
administration of chemotherapy medications. In this case, the catheter is often
mal-positioned and requires adjustment and repeat radiographic imaging in order to ensure
proper placement, ideally at the SVC-RA junction. These potentially additional procedures are
time-consuming and also expose patients, nurses and physicians to radiations.
Intracavitary electrocardiogram with an electrode placed inside the catheter during insertion
has shown identifiable changes in P-wave, which are sufficient to guide PICC tip placement.
Moreover, less procedural time and radiation are expected.
This study aims to demonstrate if this intracavitary electrocardiogram guided method is
superior to conventional surface prediction length method in terms of single-time target rate
of correct tip placement. In addition, we would like to investigate symptomatic thrombosis
incidence and its risk factors after three-valve PICC implanted among patients with malignant
tumors; to clarify procedure time used and cost of the new intracavitary ECG guiding method
and to explore the maximal P-wave amplitude of intracavity ECG real-time positioning
technology and its predictive factors.