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

This study has been terminated.

(Pre-determined stopping point met with signficant difference between intervention and control groups.)

Sponsor:

Collaborator:

North American Rescue, LLC

Information provided by (Responsible Party):

Richard Bradley, The University of Texas Health Science Center, Houston

ClinicalTrials.gov Identifier:

NCT01104103

First received: April 9, 2010

Last updated: July 16, 2012

Last verified: July 2012

History of Changes

Purpose

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	Intervention
Catheterization, Peripheral	Device: BOA(R)-Constricting IV Band Device: Standard elastic constricting band

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Supportive Care
Official Title:	The BOA(R)-Constricting IV Band: A Single Blind, Cohort Study of Effectiveness

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:

Success [ Time Frame: five minutes (average) ] [ Designated as safety issue: No ]
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:

First Stick Success [ Time Frame: Five minutes (average) ] [ Designated as safety issue: No ]
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.

Enrollment:	467
Study Start Date:	March 2010
Study Completion Date:	May 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01104103

Locations

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

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. 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.

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 History of Changes
Other Study ID Numbers:	NAR UTH 001
Study First Received:	April 9, 2010
Results First Received:	July 16, 2012
Last Updated:	July 16, 2012
Health Authority:	United States: Institutional Review Board

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

Catheterization, Peripheral
Disposable Equipment
Emergency Medical Technicians
Emergency Nursing

ClinicalTrials.gov processed this record on May 22, 2013

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