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

NCT01104103 | Terminated Results

• 1 other identifier: NAR UTH 001
• Study Type: interventional
• Target: 467
• Locations: 1 country
• Sites: 2

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.

Conditions

Catheterization, Peripheral

Keywords

Catheterization, Peripheral; Disposable Equipment; Emergency Medical Technicians; Emergency Nursing

Outcome Measures

Primary Outcomes (1)

• Success

  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.

  five minutes (average)

Secondary Outcomes (1)

• First Stick Success

  Five minutes (average)

Study Arms (2)

BOA(R)

EXPERIMENTAL

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

Standard care

ACTIVE COMPARATOR

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

Device: Standard elastic constricting band

Interventions

BOA(R)-Constricting IV Band DEVICE

Device applied in accordance with manufacturer's instructions

Also known as: NSN: 6515-01-537-2611

BOA(R)

Standard elastic constricting band DEVICE

Standard therapy

Also known as: elastic constricting band (Cardinal Health; McGaw Park, IL)

Standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Paramedics employed by the City of Houston or nurses employed by Memorial Hermann Hospital - Texas Medical Center
• Agree to participate through written consent process

You may not qualify if:

• City of Houston paramedics and Memorial Hermann Hospital - Texas Medical Center nurses who do not provide written informed consent to participate

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• North American Rescue, LLC: collaborator

Study Sites (2)

Houston Fire Department

Houston, Texas, 77002, United States

Location

Memorial Hermann Hospital-Texas Medical Center

Houston, Texas, 77030-1501, United States

Location

Related Publications (5)

• 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.

  PMID: 16280942 BACKGROUND

• 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.

  PMID: 965227 BACKGROUND

• 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.

  PMID: 16157191 BACKGROUND

• 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.

  PMID: 17554524 BACKGROUND

• 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.

  PMID: 3172305 BACKGROUND

Limitations and Caveats

There was a significant disparity between subjective opinion and objective results. Nurses and paramedics who used the BOA were uniformly positive in their comments about the device.

Results Point of Contact

• Title: Dr. Richard Bradley
• Organization: The University of Texas Health Science Center at Houston

Richard.N.Bradley@uth.tmc.edu

713-500-7878

Study Officials

• Richard N Bradley, M.D.

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor - Emergency Medicine

Study Record Dates

• First Submitted: April 9, 2010
• First Posted: April 15, 2010
• Study Start: March 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: August 20, 2012
• Results First Posted: August 20, 2012

Record last verified: 2012-07

Locations

US (2)