An Intracavitary Electrocardiographic System for Real-time Positioning Peripherally Inserted Central Catheter Tip
Condition: Peripherally Inserted Central Catheter; Intracavitary Electrocardiogram Guiding
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): ECG; Surface prediction length method
Intervention type(s): Device; Procedure
Intervention description(s): The ECG-guided PICC tip detection method will be used to identify catheter tip location during the procedural placement of the catheter. This method involves an ECG monitor which will be connected to the guidewire used for catheter placement. The changes in the ECG p-wave will guide correct PICC placement. An X-ray radiograph will be conducted to confirm the tip location after PICC placement.; The method will estimate the length of the catheter from puncture site to the junction of superior vena cava / right atrium (SVC-RA) . Tip location is placed according to the estimated length but later on will be determinated by chest X-ray performed after the placement procedure. If the tip location is not at an ideal place, additional procedures and X-ray radiograph would be required in order to ensure proper tip location.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care