Ignite Creation Date:
2024-05-06 @ 8:34 AM
Last Modification Date:
2024-10-26 @ 12:02 PM
Study NCT ID:
NCT02769442
Status:
COMPLETED
Last Update Posted:
2019-11-04
First Post:
2016-05-09
Brief Title:
Prospective Randomized Controlled Comparison of TERUMO SurFlash Plus Versus BD Insyte Autoguard in an Urban ED
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Prospective Randomized Controlled Comparison of TERUMO SurFlash Plus Versus BD Insyte Autoguard in an Urban ED
Status:
COMPLETED
Status Verified Date:
2019-10
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:
A randomized prospective comparison of two FDA approved intravenous catheters in the emergency department setting The Terumo SurFlash Plus offers novel technologies that promise to increase intravenous access success rates and decrease blood contamination of the insertion site This study would analyze these properties in our busy urban emergency department setting where time and safety of intravenous access are most critical
Detailed Description:
Rational for the Study Emergency department ED patients frequently require rapid short-term intravenous IV access for diagnosis and treatment of emergency medical conditions IV access can be uncomfortable and painful for the patient Therefore ensuring first attempt success is important Furthermore given the time-sensitive nature of emergent medical conditions immediate success helps to minimize delay in analgesic medication administration resuscitation and therapeutic interventions The process of obtaining IV access has the potential for operator exposure to blood-borne pathogens After a tourniquet is placed on an extremity positive venous pressure forces blood out of the catheter until a lure lock can be applied Traditional IV catheters require the operator to kink the catheter and apply pressure to the body of the catheter to mitigate the degree of blood leakage while simultaneously connecting the lure lock This is a complicated process that often leads to blood contamination of the insertion site and the environment including the potential for blood spillage on the bedding ground or the operator In addition to the potential for blood-born pathogen exposures this spillage leads to further patient care delays as it requires prompt cleaning
Terumo Medical Corp a leading manufacturer of medical devices has introduced a novel IV access catheter which is already FDA approved with features that promise to increase first attempt success and decrease blood contamination during the insertion process The Terumo SurFlash Plus catheter has a technology that produces a visible flash of blood at the end of the catheter when the needle is placed in the vessel and a second flash between the catheter and the needle which confirms proper catheter placement in the vein Furthermore this new catheter has a proprietary safety valve that minimizes the risk of blood exposure between needle removal and IV lure lock attachment
This study would analyze these unique properties first skin puncture success and insertion site blood contamination in a high volume urban emergency department where time and safety of IV access are critical
Purpose of Study Primary Objective Compare the rate of first-skin puncture success using the Terumo SurFlash Plus compared with the BD Insyte Autoguard
Secondary Objective Compare the frequency and severity of blood contamination of the insertion site between the two aforementioned devices
Research Design This will be a prospective randomized controlled study of the Terumo SurFlash Plus IV catheter versus the current standard ED IV catheter BD Insyte Autoguard
Study device The Terumo SurFlash Plus catheter is FDA approved and already used at multiple medical centers in the United States Gauge sizes 18 20 and 22 will be provided by TERUMO to the ED at no cost to the hospital
IV inserters operators will be Mercy Medical Center emergency department technicians nurses and providers who routinely obtain IV access in the ED
Terumo Medical Corp a leading manufacturer of medical devices has introduced a novel IV access catheter which is already FDA approved with features that promise to increase first attempt success and decrease blood contamination during the insertion process The Terumo SurFlash Plus catheter has a technology that produces a visible flash of blood at the end of the catheter when the needle is placed in the vessel and a second flash between the catheter and the needle which confirms proper catheter placement in the vein Furthermore this new catheter has a proprietary safety valve that minimizes the risk of blood exposure between needle removal and IV lure lock attachment
This study would analyze these unique properties first skin puncture success and insertion site blood contamination in a high volume urban emergency department where time and safety of IV access are critical
Purpose of Study Primary Objective Compare the rate of first-skin puncture success using the Terumo SurFlash Plus compared with the BD Insyte Autoguard
Secondary Objective Compare the frequency and severity of blood contamination of the insertion site between the two aforementioned devices
Research Design This will be a prospective randomized controlled study of the Terumo SurFlash Plus IV catheter versus the current standard ED IV catheter BD Insyte Autoguard
Study device The Terumo SurFlash Plus catheter is FDA approved and already used at multiple medical centers in the United States Gauge sizes 18 20 and 22 will be provided by TERUMO to the ED at no cost to the hospital
IV inserters operators will be Mercy Medical Center emergency department technicians nurses and providers who routinely obtain IV access in the ED
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