Catheterization Clinical Trial
Official title:
Peripherally Inserted Central Catheter Placement by IV Team Nurses Using the Sonic Flashlight
The purpose of this study is to test whether peripherally inserted central catheters can be safely placed on patients by intravenous team nurses at the bedside.
We have developed a new device for guiding invasive procedures with ultrasound (US), which
we call the Sonic Flashlight (SF). We attach a half-silvered mirror and a small flat-panel
monitor directly to an ultrasound transducer to project a virtual image of the US scan into
its actual location within the patient. This permits the operator to guide a needle through
the skin by aiming directly at the image, using natural hand-eye coordination rather than
looking away from the patient at a conventional display. We believe the SF will increase
accuracy, safety, and speed for a wide variety of invasive procedures and yield a faster
learning of these procedures than conventional US displays.
The research proposed here would bring the application of guided needle insertion to its
clinical implementation, specifically addressing the placement of the Peripherally Inserted
Central Catheter (PICC) line. The PICC line is increasingly viewed as a safe alternative to
direct central line placement in the jugular, subclavian, and femoral veins, while being
easier to maintain than a peripheral intravenous line. This study will test the hypothesis
that PICC lines can be placed by experienced intravenous (IV) team nurses using the SF for
real-time US guidance.
Thirty nurse participants (ages 18-65) will be recruited from the IV team at UPMC
Presbyterian Hospital to participate in the study. 200 patient subjects will be recruited
from the adult (18 years and older) population of patients already scheduled to receive the
PICC placement procedure; patients will have the lines placed by experienced IV team nurses
using ultrasound guidance with either the SF or conventional ultrasound (CUS). Investigators
will observe each procedure, using audio and video recording, ultrasound image data, and
other characteristics of the procedure to monitor the success of each procedure. A set of
feasibility trials will be conducted in the interventional radiology (IR) suite to assess
the level of training the nurses have received prior to the start of the comparison trial.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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