Continuous Intraosseous Vascular Access Over 48 Hours

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.

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