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

• ClinicalTrials.gov Identifier: NCT02769442
• Recruitment Status: Completed
• First Posted: May 11, 2016
• Results First Posted: June 6, 2018
• Last Update Posted: November 4, 2019
• Sponsor: University of Maryland, Baltimore
• Collaborator: Terumo Medical Corporation
• Information provided by (Responsible Party): Siamak Moayedi, MD, University of Maryland, Baltimore

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Catheters; Catheterization, Peripheral	Device: Terumo SurFlash Plus catheter; Device: BD Insyte Autoguard catheter	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 600 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prospective, Randomized Controlled Comparison of TERUMO SurFlash Plus Versus BD Insyte Autoguard in an Urban ED
• Study Start Date: June 2016
• Actual Primary Completion Date: October 2016
• Actual Study Completion Date: October 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Terumo SurFlash Plus catheter; Patients randomized to the Terumo catheter	Device: Terumo SurFlash Plus catheter
Active Comparator: BD Insyte Autoguard catheter; Patients randomized to the BD catheter	Device: BD Insyte Autoguard catheter

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With First-skin Puncture Success [ Time Frame: Within first minute of IV access ]
   1. First attempt success, defined as one skin puncture (redirection permitted) which allows for completion of a blood draw and/or flush without extravasation.
   2. Gauge size
   3. Patient prior history of difficult IV access
   4. Operator type (ED Technician/Registered Nurse/Physician Assistant/Nurse Practitioner/Resident/Attending)
   5. Operator years of experience with IV access
   6. Type of catheter used

Secondary Outcome Measures :

1. Number of Participants With Blood Visible at Site of Insertion [ Time Frame: Within first minute of IV access ]
   Compare the frequency of bleeding near the insertion site

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Maryland

Mercy Medical Center

Baltimore, Maryland, United States, 21202

Sponsors and Collaborators

University of Maryland, Baltimore

Terumo Medical Corporation

Investigators

• Principal Investigator: Siamak Moayedi, MD; Assistant Professor

More Information

Additional Information:

Youtube video describing Terumo SurFlash Plus catheter 

• Responsible Party: Siamak Moayedi, MD, PI, University of Maryland, Baltimore
• ClinicalTrials.gov Identifier: NCT02769442
• Other Study ID Numbers: HP-00068278
• First Posted: May 11, 2016
• Results First Posted: June 6, 2018
• Last Update Posted: November 4, 2019
• Last Verified: October 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Siamak Moayedi, MD, University of Maryland, Baltimore:

Intravenous; Catheter; Puncture; Peripheral Catheterization; First Stick Success; Contamination; Terumo; SurFlash