Clinical trial NCT01104103: Effectiveness Study of the BOA(R)-Constricting IV Band
Official title: The BOA(R)-Constricting IV Band: A Single Blind, Cohort Study of Effectiveness
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Catheterization, Peripheral
Keywords: Catheterization, Peripheral
Disposable Equipment
Emergency Medical Technicians
Emergency Nursing
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: North American Rescue, LLC
First posted: 2010-04-15
Enrollment: 467
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 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

Primary outcomes:
measure: Success
timeFrame: five minutes (average)
Secondary outcomes:
measure: First Stick Success
timeFrame: Five minutes (average)
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Fire Department
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Hospital-Texas Medical Center
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Richard N Bradley, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.