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

• ClinicalTrials.gov Identifier: NCT01104103
• Recruitment Status: Terminated
• First Posted: April 15, 2010
• Results First Posted: August 20, 2012
• Last Update Posted: August 20, 2012
• Sponsor: The University of Texas Health Science Center, Houston
• Collaborator: North American Rescue, LLC
• Information provided by (Responsible Party): Richard Bradley, The University of Texas Health Science Center, Houston

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Catheterization, Peripheral	Device: BOA(R)-Constricting IV Band; Device: Standard elastic constricting band	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 467 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: The BOA(R)-Constricting IV Band: A Single Blind, Cohort Study of Effectiveness
• Study Start Date: March 2010
• Actual Primary Completion Date: May 2010
• Actual Study Completion Date: May 2010

Arms and Interventions

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 Name: 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 Name: elastic constricting band (Cardinal Health; McGaw Park, IL)

Outcome Measures

Primary Outcome Measures :

1. Success [ Time Frame: five minutes (average) ]
   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.

Secondary Outcome Measures :

1. First Stick Success [ Time Frame: Five minutes (average) ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Texas

Houston Fire Department

Houston, Texas, United States, 77002

Memorial Hermann Hospital-Texas Medical Center

Houston, Texas, United States, 77030-1501

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

North American Rescue, LLC

Investigators

• Principal Investigator: Richard N Bradley, M.D.; The University of Texas Health Science Center, Houston

More Information

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.

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

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.

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.

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.

• Responsible Party: Richard Bradley, Associate Professor - Emergency Medicine, The University of Texas Health Science Center, Houston
• ClinicalTrials.gov Identifier: NCT01104103
• Other Study ID Numbers: NAR UTH 001
• First Posted: April 15, 2010
• Results First Posted: August 20, 2012
• Last Update Posted: August 20, 2012
• Last Verified: July 2012

Keywords provided by Richard Bradley, The University of Texas Health Science Center, Houston:

Catheterization, Peripheral; Disposable Equipment; Emergency Medical Technicians; Emergency Nursing