Effectiveness Study of the BOA(R)-Constricting IV Band

Catheterization, Peripheral Clinical Trial

Official title:

The BOA(R)-Constricting IV Band: A Single Blind, Cohort Study of Effectiveness

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01104103
• Other study ID #: NAR UTH 001
• Status: Terminated
• Phase: N/A
• First received: April 9, 2010
• Last updated: July 16, 2012
• Start date: March 2010
• Est. completion date: May 2010

Study information

• Verified date: July 2012
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether the BOA(R)-Constricting IV Band is superior to standard methods for starting an IV.

Description:

We will test the hypothesis that paramedics and nurses treating in- and out-of-hospital patients with a BOA(R)-Constricting IV Band, compared to paramedics using standard treatment, will have better success rates for peripheral IV access.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 467
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Paramedics employed by the City of Houston or nurses employed by Memorial Hermann Hospital - Texas Medical Center

• Agree to participate through written consent process

Exclusion Criteria:

• City of Houston paramedics and Memorial Hermann Hospital - Texas Medical Center nurses who do not provide written informed consent to participate

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Catheterization, Peripheral

Intervention

Device:
• BOA(R)-Constricting IV Band
Device applied in accordance with manufacturer's instructions
• Standard elastic constricting band
Standard therapy

Locations

Country	Name	City	State
United States	Houston Fire Department	Houston	Texas
United States	Memorial Hermann Hospital-Texas Medical Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	North American Rescue, LLC

Country where clinical trial is conducted

United States, 

References & Publications (5)

Black KJ, Pusic MV, Harmidy D, McGillivray D. Pediatric intravenous insertion in the emergency department: bevel up or bevel down? Pediatr Emerg Care. 2005 Nov;21(11):707-11. — View Citation

Jacobson AF, Winslow EH. Variables influencing intravenous catheter insertion difficulty and failure: an analysis of 339 intravenous catheter insertions. Heart Lung. 2005 Sep-Oct;34(5):345-59. — View Citation

Lapostolle F, Catineau J, Garrigue B, Monmarteau V, Houssaye T, Vecci I, Tréoux V, Hospital B, Crocheton N, Adnet F. Prospective evaluation of peripheral venous access difficulty in emergency care. Intensive Care Med. 2007 Aug;33(8):1452-7. Epub 2007 Jun 7. — View Citation

Meier J, Schreier E. Human plasma levels of some anti-migraine drugs. Headache. 1976 Jul;16(3):96-104. — View Citation

Pons PT, Moore EE, Cusick JM, Brunko M, Antuna B, Owens L. Prehospital venous access in an urban paramedic system--a prospective on-scene analysis. J Trauma. 1988 Oct;28(10):1460-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success	This outcome will measure self-reported success at starting the peripheral intravenous lines in the upper extremity of adults. Success is defined as an IV line through which blood may be aspirated and flushes freely without evidence of fluid extravasation. To be successful, the IV must be placed within a maximum of three attempts. We will report the number and percentage of patients with successful for both therapies.	five minutes (average)	No
Secondary	First Stick Success	This outcome will report the number of IV attempts as defined by the tip of the needle piercing the skin. The results for each IV attempt will be an ordinal number between one and three. We will compare the number and percentage of patients in each group (1, 2, or 3 sticks) between the two therapies.	Five minutes (average)	No