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

NCT ID: NCT01104103

Last Updated: 2012-08-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

467 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-05-31

Brief Summary

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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

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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.

Conditions

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Catheterization, Peripheral

Keywords

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Catheterization, Peripheral Disposable Equipment Emergency Medical Technicians Emergency Nursing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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BOA(R)

Nurse or paramedic uses the BOA(R)-Constricting IV Band to attempt placement of an upper extremity IV in an adult

Group Type EXPERIMENTAL

BOA(R)-Constricting IV Band

Intervention Type DEVICE

Device applied in accordance with manufacturer's instructions

Standard care

Nurse or paramedic uses standard IV starting technique in the upper extremity of adults

Group Type ACTIVE_COMPARATOR

Standard elastic constricting band

Intervention Type DEVICE

Standard therapy

Interventions

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BOA(R)-Constricting IV Band

Device applied in accordance with manufacturer's instructions

Intervention Type DEVICE

Standard elastic constricting band

Standard therapy

Intervention Type DEVICE

Other Intervention Names

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NSN: 6515-01-537-2611 elastic constricting band (Cardinal Health; McGaw Park, IL)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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North American Rescue, LLC

UNKNOWN

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Richard Bradley

Associate Professor - Emergency Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard N Bradley, M.D.

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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Houston Fire Department

Houston, Texas, United States

Site Status

Memorial Hermann Hospital-Texas Medical Center

Houston, Texas, United States

Site Status

Countries

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United States

References

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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. doi: 10.1097/01.pec.0000186422.77140.1f.

Reference Type BACKGROUND
PMID: 16280942 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 965227 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16157191 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17554524 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3172305 (View on PubMed)

Other Identifiers

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NAR UTH 001

Identifier Type: -

Identifier Source: org_study_id