Catheterization, Peripheral
Conditions
Keywords
Catheterization, Peripheral, Disposable Equipment, Emergency Medical Technicians, Emergency Nursing
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.
Interventions
DEVICEBOA(R)-Constricting IV Band
Device applied in accordance with manufacturer's instructions
DEVICEStandard elastic constricting band
Standard therapy
Sponsors
The University of Texas Health Science Center, Houston
North American Rescue, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| BOA(R) Nurse or paramedic uses the BOA(R)-Constricting IV Band to attempt placement of an upper extremity IV in an adult | 243 |
| Standard Care Nurse or paramedic uses standard IV starting technique in the upper extremity of adults | 224 |
| Total | 467 |
Baseline characteristics
| Characteristic | Standard Care | BOA(R) | Total |
|---|---|---|---|
| Age Categorical <=18 years | 2 participants | 2 participants | 4 participants |
| Age Categorical >=65 years | 43 participants | 60 participants | 103 participants |
| Age Categorical Between 18 and 65 years | 178 participants | 175 participants | 353 participants |
| Age Continuous | 46.78 years STANDARD_DEVIATION 19.01 | 50.17 years STANDARD_DEVIATION 19.54 | 48.53 years STANDARD_DEVIATION 19.34 |
| Gender Female | 104 participants | 122 participants | 226 participants |
| Gender Male | 113 participants | 115 participants | 228 participants |
| Region of Enrollment United States | 224 participants | 243 participants | 467 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 243 | 0 / 224 |
| serious Total, serious adverse events | 0 / 243 | 0 / 224 |
Outcome results
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.
Time frame: five minutes (average)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BOA(R) | Success | 198 participants |
| Standard Care | Success | 214 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.
Time frame: Five minutes (average)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BOA(R) | First Stick Success | 167 participants |
| Standard Care | First Stick Success | 186 participants |