Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00226213
Status:
COMPLETED
Last Update Posted:
2007-12-13
First Post:
2005-09-22
Brief Title:
Peripherally Inserted Central Catheter Placement by Interventional Radiologists Using the Sonic Flashlight
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Peripherally Inserted Central Catheter Placement by Interventional Radiologists Using the Sonic Flashlight
Status:
COMPLETED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 operators 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None