Intraosseous Vascular Access
Conditions
Keywords
IO access, Intraosseous vascular access, EZ-IO
Brief summary
A prospective study to determine the safety of intraosseous (IO) access for a period up to 48 hours in healthy adult volunteers and volunteers with a history of mild to moderate renal disease and/or controlled diabetes.
Detailed description
A prospective, study to determine the safety of intraosseous (IO) access for a period up to 48 hours, in healthy adult volunteers and volunteers with a history of being health-compromised, including patients with mild to moderate renal disease (National Health and Nutrition Examination Survey Stage 1 to 3) and/or patients with controlled diabetes. Subjects will be randomized to receive IO access in the proximal tibia insertion site or the proximal humerus insertion site using the EZ-IO intraosseous vascular access system. The hypothesis is that there will be no serious complications for the subjects during a 48 hour IO catheter dwell time in either place.
Interventions
DEVICEEZ-IO
To have an EZ-IO placed up to 48 hours
Sponsors
Vidacare Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 21 years or older * Self Identifying as having poor vascular access * Healthy or Having at least one of the following conditions: * Controlled diabetes, as evidenced by a glycosylated hemoglobin A1c (HbA1c) value of less than or equal to 8% at the time of screening. or * Renal disease, Stages 1 to 3, as evidenced by the presence of albuminuria at the time of screening. Subjects albumin-creatinine ratio (ACR) must fall within the microalbuminuria or macroalbuminuria values: Microalbuminuria - ACR 17-250 mcg/mg for men; 25-355 mcg/mg for women or, Macroalbuminuria- ACR \>250 mcg/mg for men; \>355 mcg/mg for women
Exclusion criteria
* Imprisoned * Self identifying as pregnant * Cognitively impaired * Fracture in target bone * Excessive tissue and/or absence of adequated anatomical landmarks in target bone * Signs and symptoms of infection in target area * IO insertion in past 48 hours, prosthetic limb or joint or other significant orthopedic procedure in target bone * Intravenous infusion within the past 30 days * Current use of anti-coagulants * Previous adverse reaction or known allergy to Lidocaine * Current cardiac condition requiring pacemaker * Currently taking beta blockers or calcium channel blockers for heart arrhythmia (use of beta blockers or calcium channel blocker for hypertension is allowed when indication of hypertension can be confirmed by physician * Previous surgery for peripheral arterial disease * History of ulcers to the extremities * History of bilateral lymph node dissection in the arms or legs * Known sickle-cell disease * signs or symptoms of vascular disease or vascular insufficiencies to the extremities, as identified upon physical examination * History of peripheral vascular disease * Hyperkalemia as evidenced by potassium level greater than 5.1 mmol/L the upper limit of hte normal reference range at screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serious Complications From Intraosseous (IO) Access | 48 hours | Presence of serious complications from 48 hour intraosseous (IO) vascular access using EZ-IO. |
Countries
United States
Participant flow
Recruitment details
November 2014 - January 2016: subjects with controlled diabetes and/or mild renal disease only were enrolled. January 2016 - July 2016: healthy subjects and subjects with controlled diabetes and/or mild renal disease were enrolled. Amendment for healthy subjects approved by FDA in advance of implementation.
Participants by arm
| Arm | Count |
|---|---|
| Renal Disease Those with mild to moderate renal disease and had an EZ-IO for 48 hours
EZ-IO: To have an EZ-IO placed up to 48 hours | 0 |
| Diabetes Those with controlled diabetes and had an EZ-IO for 48 hours
EZ-IO: To have an EZ-IO placed up to 48 hours | 40 |
| Renal Disease and Diabetes Those with both mild to moderate renal disease and controlled diabetes and had an EZ-IO for 48 hours
EZ-IO: To have an EZ-IO placed up to 48 hours | 3 |
| Healthy Adults Those who are healthy, defined as lacking co-morbidities that are a study exclusion, and had an EZ-IO for 48 hours
EZ-IO: To have an EZ-IO placed up to 48 hours | 84 |
| Total | 127 |
Baseline characteristics
| Characteristic | Diabetes | Renal Disease and Diabetes | Healthy Adults | Total |
|---|---|---|---|---|
| Age, Continuous | 53.6 years STANDARD_DEVIATION 11.7 | 47 years STANDARD_DEVIATION 12.3 | 41.4 years STANDARD_DEVIATION 12.7 | 45.4 years STANDARD_DEVIATION 13.5 |
| Race/Ethnicity, Customized Race/Ethnicity American Indian / Alaska Native | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black | 10 Participants | 0 Participants | 17 Participants | 27 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black and Hispanic / Latino | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic / Latino | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Native Hawaii / Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 12 Participants | 1 Participants | 41 Participants | 54 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White and Hispanic / Latino | 17 Participants | 2 Participants | 22 Participants | 41 Participants |
| Region of Enrollment United States | 40 participants | 3 participants | 84 participants | 127 participants |
| Sex: Female, Male Female | 14 Participants | 1 Participants | 31 Participants | 46 Participants |
| Sex: Female, Male Male | 26 Participants | 2 Participants | 53 Participants | 81 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 40 | 0 / 3 | 0 / 84 |
| other Total, other adverse events | 0 / 0 | 33 / 40 | 2 / 3 | 77 / 84 |
| serious Total, serious adverse events | 0 / 0 | 0 / 40 | 0 / 3 | 0 / 84 |
Outcome results
Primary
Serious Complications From Intraosseous (IO) Access
Presence of serious complications from 48 hour intraosseous (IO) vascular access using EZ-IO.
Time frame: 48 hours
Population: Evaluable subjects included in primary endpoint analysis. Non-evaluable subjects, defined by protocol as subjects who withdrew consent or were discontinued from the study for non-compliance or unwillingness to comply with study requirements before completing Day 3 procedures (48 hour dwell time), were replaced. There were 6 non-evaluable subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Renal Disease | Serious Complications From Intraosseous (IO) Access | 0 Participants |
| Diabetes | Serious Complications From Intraosseous (IO) Access | 0 Participants |
| Renal Disease and Diabetes | Serious Complications From Intraosseous (IO) Access | 0 Participants |
| Healthy Adults | Serious Complications From Intraosseous (IO) Access | 0 Participants |