Prospective, Randomized Controlled Comparison of TERUMO SurFlash Plus Versus BD Insyte Autoguard in an Urban ED
1 other identifier
interventional
600
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2016
CompletedFirst Posted
Study publicly available on registry
May 11, 2016
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedResults Posted
Study results publicly available
June 6, 2018
CompletedNovember 4, 2019
October 1, 2019
4 months
May 9, 2016
February 7, 2018
October 31, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With First-skin Puncture Success
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
Within first minute of IV access
Secondary Outcomes (1)
Number of Participants With Blood Visible at Site of Insertion
Within first minute of IV access
Study Arms (2)
Terumo SurFlash Plus catheter
EXPERIMENTALPatients randomized to the Terumo catheter
BD Insyte Autoguard catheter
ACTIVE COMPARATORPatients randomized to the BD catheter
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Medically unstable
- Agitated or psychiatrically unstable
- Lacking capacity to consent, such as with altered mental status.
- Unable to speak and read English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Maryland, Baltimorelead
- Terumo Medical Corporationcollaborator
Study Sites (1)
Mercy Medical Center
Baltimore, Maryland, 21202, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Siamak Moayedi Md
- Organization
- University of Maryland School of Medicine, Department of Emergency Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Siamak Moayedi, MD
Assistant Professor
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
May 9, 2016
First Posted
May 11, 2016
Study Start
June 1, 2016
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
November 4, 2019
Results First Posted
June 6, 2018
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share