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

Study Overview
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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.

Official Title
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The BOA(R)-Constricting IV Band: A Single Blind, Cohort Study of Effectiveness

Conditions
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Catheterization, Peripheral

Intervention / Treatment
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* Device: BOA(R)-Constricting IV Band
* Device: Standard elastic constricting band


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BOA(R)<br>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<br>* Device applied in accordance with manufacturer's instructions<br>* Other names: NSN: 6515-01-537-2611;|
| Active Comparator: Standard care<br>Nurse or paramedic uses standard IV starting technique in the upper extremity of adults | Device: Standard elastic constricting band<br>* Standard therapy<br>* Other names: elastic constricting band (Cardinal Health; McGaw Park, IL);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First Stick Success | 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. | Five minutes (average) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Catheterization, Peripheral, Disposable Equipment, Emergency Medical Technicians, Emergency Nursing