Difficult Peripheral IV Access
Conditions
Keywords
Intraosseous (IO) vascular access
Brief summary
By doing this study, the investigators hope to learn whether patients with difficult to obtain IV access who are treated with IO access are more satisfied with their care and have better outcomes. The investigators are specifically studying the time difference between groups and the difference in the number of attempts required to obtain vascular access and begin to treat with fluids and medications. The study will also measure patient satisfaction and procedural pain, the frequency of central line placement, the length of stay in the hospital and emergency department, and adverse events to intravascular access to determine whether IO access can improve these measures. The investigators hypothesize that the use of a protocol utilizing an IO device for select patients with failed IV access will reduce the time requirements to obtain vascular access, reduce the number of attempts needed to obtain IV access, reduce the ED LOS, and have no negative impact on patient satisfaction compared to the current ED practices.
Interventions
PROCEDUREIO access using EZ-IO®
IO line placed using an FDA-approved device called an EZ-IO®.
Sponsors
University of Pennsylvania
WellSpan Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years of age or older 2. Hemodynamically stable 3. Speaks English 4. Able to consent 5. Has difficult IV access
Exclusion criteria
1\. Patients who are younger than 18 years of age, b) lack English fluency c) are unable to give informed consent d) require immediate central venous access e) have a history of osteomyelitis in the only target location of IO access f) have a fracture in the bone of the only target IO site g) have received an IO in the last 24 hours of the only target site h) are allergic to lidocaine i) pregnant or j) require a contrast CT scan as part of their ED care will be excluded. While pregnant patients may benefit from rescue access the use of lidocaine to anesthetize the medullary space has not been studied in this population.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Successful Placement of a Functioning USGIV/IO | at time of vascular access |
| Number of Successful Placements | at time of vascular access |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care Standard of care | 11 |
| IO Access IO access | 11 |
| Total | 22 |
Baseline characteristics
| Characteristic | Standard of Care | IO Access | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 1 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 10 Participants | 19 Participants |
| Sex: Female, Male Female | 7 Participants | 8 Participants | 15 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 11 |
| other Total, other adverse events | 0 / 11 | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 |
Outcome results
Primary
Number of Successful Placements
Time frame: at time of vascular access
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care | Number of Successful Placements | 11 successful placements |
| &Apos;IO Access Using EZ-IO® | Number of Successful Placements | 8 successful placements |
Primary
Time to Successful Placement of a Functioning USGIV/IO
Time frame: at time of vascular access
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care | Time to Successful Placement of a Functioning USGIV/IO | 163.7 seconds | Standard Deviation 177.9 |
| &Apos;IO Access Using EZ-IO® | Time to Successful Placement of a Functioning USGIV/IO | 67.3 seconds | Standard Deviation 98.5 |