Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00226226
Status:
COMPLETED
Last Update Posted:
2008-02-15
First Post:
2005-09-22
Brief Title:
Peripherally Inserted Central Catheter Placement by IV Team Nurses Using the Sonic Flashlight
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Peripherally Inserted Central Catheter Placement by IV Team Nurses Using the Sonic Flashlight
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 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
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
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
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