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Pre-determined stopping point met with signficant difference between intervention and control groups.
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| Name | Class |
|---|---|
| North American Rescue, LLC | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BOA(R) | Experimental | Nurse or paramedic uses the BOA(R)-Constricting IV Band to attempt placement of an upper extremity IV in an adult |
|
| Standard care | Active Comparator | Nurse or paramedic uses standard IV starting technique in the upper extremity of adults |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BOA(R)-Constricting IV Band | Device | Device applied in accordance with manufacturer's instructions |
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard N Bradley, M.D. | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston Fire Department | Houston | Texas | 77002 | United States | ||
| Memorial Hermann Hospital-Texas Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16280942 | Background | 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. | |
| 965227 | 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. |
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We randomly assigned the 26 healthcare providers (16 paramedics, 10 nurses) to use either the BOA® Constricting Band or elastic tourniquets for all IV attempts during the study. Thirteen subjects were in each group. Those that were randomized to the BOA group received training in the use of the device according to the manufacturer's instructions.
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| ID | Title | Description |
|---|---|---|
| FG000 | BOA(R) | Nurse or paramedic uses the BOA(R)-Constricting IV Band to attempt placement of an upper extremity IV in an adult |
| FG001 | Standard Care | Nurse or paramedic uses standard IV starting technique in the upper extremity of adults |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BOA(R) | Nurse or paramedic uses the BOA(R)-Constricting IV Band to attempt placement of an upper extremity IV in an adult |
| BG001 | Standard Care | Nurse or paramedic uses standard IV starting technique in the upper extremity of adults |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Categorical | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | five minutes (average) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BOA(R) | Nurse or paramedic uses the BOA(R)-Constricting IV Band to attempt placement of an upper extremity IV in an adult |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Richard Bradley | The University of Texas Health Science Center at Houston | 713-500-7878 | Richard.N.Bradley@uth.tmc.edu |
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| Standard elastic constricting band | Device | Standard therapy |
|
|
| Houston |
| Texas |
| 77030-1501 |
| United States |
| 16157191 | 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. |
| 17554524 | 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. |
| 3172305 | 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. |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Gender | Number | participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | 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. | Posted | Number | participants | Five minutes (average) |
|
|
|
| 0 |
| 243 |
| 0 |
| 243 |
| EG001 | Standard Care | Nurse or paramedic uses standard IV starting technique in the upper extremity of adults | 0 | 224 | 0 | 224 |
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