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

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

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

Study Overview

• Status: Terminated
• Conditions: Catheterization, Peripheral
• Intervention / Treatment: Device: BOA(R)-Constricting IV Band; Device: Standard elastic constricting band

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 467
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77002
      • Houston Fire Department
    • Houston, Texas, United States, 77030-1501
      • Memorial Hermann Hospital-Texas Medical Center

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BOA(R); Nurse or paramedic uses the BOA(R)-Constricting IV Band to attempt placement of an upper extremity IV in an adult	Device: BOA(R)-Constricting IV Band; Device applied in accordance with manufacturer's instructions; Other Names: NSN: 6515-01-537-2611
Active Comparator: Standard care; Nurse or paramedic uses standard IV starting technique in the upper extremity of adults	Device: Standard elastic constricting band; Standard therapy; Other Names: elastic constricting band (Cardinal Health; McGaw Park, IL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: North American Rescue, LLC
• Investigators: Principal Investigator: Richard N Bradley, M.D., The University of Texas Health Science Center, Houston

Publications and helpful links

General Publications

• 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. doi: 10.1097/01.pec.0000186422.77140.1f.
• Meier J, Schreier E. Human plasma levels of some anti-migraine drugs. Headache. 1976 Jul;16(3):96-104. doi: 10.1111/j.1526-4610.1976.hed1603096.x. No abstract available.
• 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. doi: 10.1016/j.hrtlng.2005.04.002.
• Lapostolle F, Catineau J, Garrigue B, Monmarteau V, Houssaye T, Vecci I, Treoux 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. doi: 10.1007/s00134-007-0634-y. Epub 2007 Jun 7.
• 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. doi: 10.1097/00005373-198810000-00009.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: April 9, 2010
• First Submitted That Met QC Criteria: April 13, 2010
• First Posted (Estimate): April 15, 2010

Study Record Updates

• Last Update Posted (Estimate): August 20, 2012
• Last Update Submitted That Met QC Criteria: July 16, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Emergency Nursing; Catheterization, Peripheral; Disposable Equipment; Emergency Medical Technicians
• Other Study ID Numbers: NAR UTH 001