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

Not Applicable

Terminated

• Conditions: Catheterization, Peripheral
• Interventions: Device: Standard elastic constricting band; Device: BOA(R)-Constricting IV Band

• Registration Number: NCT01104103
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-04-09
• Study First Submitted QC: 2010-04-13
• Study First Posted: 2010-04-15
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2012-07
• Results First Submitted: 2012-07-16
• Results First Submitted QC: 2012-07-16
• Last Update Submitted: 2012-07-16
• Results First Posted: 2012-08-20
• Last Update Posted: 2012-08-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 467

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard care	Standard elastic constricting band	Nurse or paramedic uses standard IV starting technique in the upper extremity of adults
BOA(R)	BOA(R)-Constricting IV Band	Nurse or paramedic uses the BOA(R)-Constricting IV Band to attempt placement of an upper extremity IV in an adult

Primary Outcome Measures

Name	Time	Method
Success	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

Name	Time	Method
First Stick Success	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.

Trial Locations

Locations (2)

Houston Fire Department; 🇺🇸 Houston, Texas, United States

Memorial Hermann Hospital-Texas Medical Center; 🇺🇸 Houston, Texas, United States