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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:
ClinicalTrials.gov Identifier:
NCT01104103
First Posted: April 15, 2010
Last Update Posted: August 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
North American Rescue, LLC
Information provided by (Responsible Party):
Richard Bradley, The University of Texas Health Science Center, Houston
  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
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

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

Primary Outcome Measures:
  • 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:
  • 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.


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01104103


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:
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
First Submitted: April 9, 2010
First Posted: April 15, 2010
Results First Submitted: July 16, 2012
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