- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02769442
Prospective, Randomized Controlled Comparison of TERUMO SurFlash Plus Versus BD Insyte Autoguard in an Urban ED
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21202
- Mercy Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Terumo SurFlash Plus catheter
Patients randomized to the Terumo catheter
|
|
ACTIVE_COMPARATOR: BD Insyte Autoguard catheter
Patients randomized to the BD catheter
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With First-skin Puncture Success
Time Frame: Within first minute of IV access
|
|
Within first minute of IV access
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Within first minute of IV access
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Siamak Moayedi, MD, Assistant professor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HP-00068278
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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