Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00330590
Status:
COMPLETED
Last Update Posted:
2008-02-15
First Post:
2006-05-26
Brief Title:
Central Venous Access Catheter Placement Using the Sonic Flashlight
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Central Venous Access Catheter Placement by Interventional Radiologists Using the Sonic Flashlight for Real Time Ultrasound Guidance
Status:
COMPLETED
Status Verified Date:
2008-02
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 investigators have developed a new device for guiding invasive procedures with ultrasound US which they call the sonic flashlight SF They 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 The device requires no tracking or head-mounted apparatus and provides an intuitive merger of the visual exterior of the patient with an in situ ultrasound image which can be simultaneously viewed by others assisting the operator The investigators believe the SF will increase the accuracy safety and speed for a wide variety of invasive procedures and will require less extensive training than conventional US displays
Given the wide variety of procedures for which the SF could be used the investigators have narrowed their focus to applying it to a single application vascular access They have demonstrated clinically that the SF can be used successfully to guide the placement of the peripherally inserted central catheter PICC lines The research proposed here will expand this application to include the insertion of other central venous access CVA lines through the internal jugular vein subclavian vein and femoral vein The historical approach to CVA line placements has involved the physical exam and identification of visible landmarks With the introduction and common usage of ultrasound it has become routine to use ultrasound guidance
Much of the difficulty in learning conventional ultrasound CUS guided procedures stems from the displaced sense of hand-eye coordination that occurs when the operator looks away from the operating field to see the ultrasound display The SF directly addresses many of these issues and therefore the investigators believe that it is well suited for this application They have already shown that novice US users learn vascular access procedures in training phantoms more quickly using the SF than CUS They have also shown that intravenous IV team nurses already proficient in CUS guided PICC lines perform vascular access in training phantoms more quickly using the SF than CUS guidance Finally as mentioned earlier the investigators have shown that the SF can be used successfully to guide the placement of PICC lines This study will test the hypothesis that the SF will successfully facilitate catheter placement in the subclavian femoral and internal jugular veins demonstrating equal vasculature visualization as conventional ultrasound
Given the wide variety of procedures for which the SF could be used the investigators have narrowed their focus to applying it to a single application vascular access They have demonstrated clinically that the SF can be used successfully to guide the placement of the peripherally inserted central catheter PICC lines The research proposed here will expand this application to include the insertion of other central venous access CVA lines through the internal jugular vein subclavian vein and femoral vein The historical approach to CVA line placements has involved the physical exam and identification of visible landmarks With the introduction and common usage of ultrasound it has become routine to use ultrasound guidance
Much of the difficulty in learning conventional ultrasound CUS guided procedures stems from the displaced sense of hand-eye coordination that occurs when the operator looks away from the operating field to see the ultrasound display The SF directly addresses many of these issues and therefore the investigators believe that it is well suited for this application They have already shown that novice US users learn vascular access procedures in training phantoms more quickly using the SF than CUS They have also shown that intravenous IV team nurses already proficient in CUS guided PICC lines perform vascular access in training phantoms more quickly using the SF than CUS guidance Finally as mentioned earlier the investigators have shown that the SF can be used successfully to guide the placement of PICC lines This study will test the hypothesis that the SF will successfully facilitate catheter placement in the subclavian femoral and internal jugular veins demonstrating equal vasculature visualization as conventional ultrasound
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 The device requires no tracking or head-mounted apparatus and provides an intuitive merger of the visual exterior of the patient with an in situ ultrasound image which can be simultaneously viewed by others assisting the operator We believe the SF will increase accuracy safety and speed for a wide variety of invasive procedures and will require less extensive training than conventional US displays
Given the wide variety of procedures for which the SF could be used we have narrowed our focus to applying it to a single application vascular access We have demonstrated clinically that the SF can be used successfully to guide the placement of the Peripherally Inserted Central Catheter PICC lines The research proposed here will expand this application to include the insertion of other Central Venous Access CVA lines through the internal jugular vein subclavian vein and femoral vein The historical approach to CVA line placements has involved the physical exam and identification of visible landmarks With the introduction and common usage of ultrasound it has become routine to use ultrasound guidance
Much of the difficulty in learning conventional ultrasound CUS guided procedures stems from the displaced sense of hand-eye coordination that occurs when the operator looks away from the operating field to see the ultrasound display The SF directly addresses many of these issues and therefore we believe that it is well suited for this application We have already shown that novice US users learn vascular access procedures in training phantoms more quickly using the SF than CUS We have also shown that IV team nurses already proficient in CUS guided PICC lines perform vascular access in training phantoms more quickly using the SF than CUS guidance Finally as mentioned earlier we have shown that the SF can be used successfully to guide the placement of PICC lines This study will test the hypothesis that the SF will successfully facilitate catheter placement in the subclavian femoral and internal jugular veins demonstrating equal vasculature visualization as conventional ultrasound
Given the wide variety of procedures for which the SF could be used we have narrowed our focus to applying it to a single application vascular access We have demonstrated clinically that the SF can be used successfully to guide the placement of the Peripherally Inserted Central Catheter PICC lines The research proposed here will expand this application to include the insertion of other Central Venous Access CVA lines through the internal jugular vein subclavian vein and femoral vein The historical approach to CVA line placements has involved the physical exam and identification of visible landmarks With the introduction and common usage of ultrasound it has become routine to use ultrasound guidance
Much of the difficulty in learning conventional ultrasound CUS guided procedures stems from the displaced sense of hand-eye coordination that occurs when the operator looks away from the operating field to see the ultrasound display The SF directly addresses many of these issues and therefore we believe that it is well suited for this application We have already shown that novice US users learn vascular access procedures in training phantoms more quickly using the SF than CUS We have also shown that IV team nurses already proficient in CUS guided PICC lines perform vascular access in training phantoms more quickly using the SF than CUS guidance Finally as mentioned earlier we have shown that the SF can be used successfully to guide the placement of PICC lines This study will test the hypothesis that the SF will successfully facilitate catheter placement in the subclavian femoral and internal jugular veins demonstrating equal vasculature visualization as conventional ultrasound
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