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Peripherally Inserted Central Catheter Placement by Interventional Radiologists Using the Sonic Flashlight

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ClinicalTrials.gov Identifier: NCT00226213
Recruitment Status : Completed
First Posted : September 26, 2005
Last Update Posted : December 13, 2007
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
University of Pittsburgh

Brief Summary:
The purpose of the study is to perform the first clinical trial on human subjects using the Sonic Flashlight (SF) to guide placement of Peripherally Inserted Central Catheters (PICCs).

Condition or disease Intervention/treatment Phase
Catheterization Procedure: Peripherally Inserted Central Catheter Placement Phase 1

Detailed Description:

The SF prototype is an ultrasound (US) display device under development at our institution that replaces the traditional US monitor by using a half -silvered mirror to reflect real-time US images into the body. When the operator looks through the half -silvered mirror, the US image appears to float beneath the surface of the skin, exactly where it is being scanned. The SF merges the US image, probe, needle, operator's hands, and patient into the same field of view, making procedures more intuitive to the novice user, in contrast to conventional US (CUS) guided procedures, where hand-eye coordination is displaced, forcing the operator to look away from the field to see the US screen. We have previously shown that VA in phantoms is easier to use, faster to use, and faster to learn than CUS in novice and experienced US users. The current SF prototype uses a 10MHz US system (Terason, Burlington, MA) modified by attaching a small flat-panel display (AM550L OLED, Kodak, Rochester, NY) and a 20x50x1mm half -silvered mirror to the probe. A standard, clear, sterile polyethylene US probe cover was placed over the entire SF to sterilize the device. 15 subjects needing PICC lines were enrolled in this study. Scanning the upper arm of each patient with the SF, the basilic vein, brachial vein, and brachial artery were identified on the in situ US image. A 21ga needle was guided into the basilic or brachial vein. The number of attempts, or sticks, per PICC line placement, specific vein accessed, and reason for a failed attempt were recorded.

The vasculature was clearly visualized in situ using the SF. The needle was aimed and easily inserted into the basilic or brachial vein, and the needle tip visualized at its expected location. Successful vascular access was obtained with all 15 subjects, 13 of 15 on the first attempt, and 2 of 15 on the second attempt. 3 of the 15 lines encountered mild blurriness looking through the SF due to inconsistent optical properties of the probe cover.

This study shows that venous access can be obtained using the SF. Once the optical problems with the probe covers are addressed, the SF will be ready for a larger clinical trial.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Peripherally Inserted Central Catheter Placement by Interventional Radiologists Using the Sonic Flashlight
Study Start Date : February 2005
Study Completion Date : June 2007



Primary Outcome Measures :
  1. PICC lines successfully placed using the Sonic Flashlight

Secondary Outcome Measures :
  1. PICC lines successfully placed using conventional ultrasound machines


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Undergoing a PICC line insertion as part of their standard care

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00226213


Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15260
Sponsors and Collaborators
University of Pittsburgh
National Institutes of Health (NIH)
Investigators
Principal Investigator: George D Stetten, MD, PhD University of Pittsburgh

ClinicalTrials.gov Identifier: NCT00226213     History of Changes
Other Study ID Numbers: 0406143
First Posted: September 26, 2005    Key Record Dates
Last Update Posted: December 13, 2007
Last Verified: December 2007