Prospective, Randomized Controlled Comparison of TERUMO SurFlash Plus Versus BD Insyte Autoguard in an Urban ED

NCT ID: NCT02769442

Last Updated: 2019-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2016-10-31

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.

Conditions

Catheters; Catheterization, Peripheral

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Terumo SurFlash Plus catheter

Patients randomized to the Terumo catheter

Group Type: EXPERIMENTAL

Terumo SurFlash Plus catheter

Intervention Type: DEVICE

BD Insyte Autoguard catheter

Patients randomized to the BD catheter

Group Type: ACTIVE_COMPARATOR

BD Insyte Autoguard catheter

Intervention Type: DEVICE

Interventions

Terumo SurFlash Plus catheter

Intervention Type: DEVICE

BD Insyte Autoguard catheter

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adult ED patient requiring an IV for clinical care
• Hemodynamically stable: pulse >50 and <130, MAP>60
• Willing to read (or be read to) the informed consent and participate in study

Exclusion Criteria

• Medically unstable
• Agitated or psychiatrically unstable
• Lacking capacity to consent, such as with altered mental status.
• Unable to speak and read English

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Terumo Medical Corporation

INDUSTRY

Sponsor Role: collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Siamak Moayedi, MD

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Siamak Moayedi, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

Mercy Medical Center

Baltimore, Maryland, United States

Countries

United States

Related Links

https://www.youtube.com/watch?v=5ww5tgnPuXg

Youtube video describing Terumo SurFlash Plus catheter

Other Identifiers

HP-00068278

Identifier Type: -

Identifier Source: org_study_id