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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 August 28, 2014