Peripherally Inserted Central Catheter Placement by IV Team Nurses Using the Sonic Flashlight

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00226226
First received: September 22, 2005
Last updated: February 10, 2008
Last verified: February 2008
  Purpose

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.


Condition Intervention Phase
Catheterization
Procedure: Peripherally Inserted Central Catheter Placement
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Peripherally Inserted Central Catheter Placement by IV Team Nurses Using the Sonic Flashlight

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • PICC line successfully placed by intravenous team nurses using the Sonic Flashlight

Secondary Outcome Measures:
  • PICC line successfully placed by intravenous team nurses using conventional ultrasound

Estimated Enrollment: 230
Study Start Date: June 2006
Study Completion Date: June 2007
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 or older
  • Undergoing peripherally inserted central catheter placement as standard of care.

Exclusion Criteria:

  • None
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00226226

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15260
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: George D Stetten, MD, PhD University of Pittsburgh
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00226226     History of Changes
Other Study ID Numbers: 0506042
Study First Received: September 22, 2005
Last Updated: February 10, 2008
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 18, 2014