Continuous Intraosseous Vascular Access Over 48 Hours

Not Applicable

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Diabetes	EZ-IO	Those with controlled diabetes and had an EZ-IO for 48 hours
Renal disease and diabetes	EZ-IO	Those with both mild to moderate renal disease and controlled diabetes and had an EZ-IO for 48 hours
Renal Disease	EZ-IO	Those with mild to moderate renal disease and had an EZ-IO for 48 hours
Healthy adults	EZ-IO	Those who are healthy, defined as lacking co-morbidities that are a study exclusion, and had an EZ-IO for 48 hours

Primary Outcome Measures

Name	Time	Method
Serious Complications From Intraosseous (IO) Access	48 hours	Presence of serious complications from 48 hour intraosseous (IO) vascular access using EZ-IO.

Secondary Outcome Measures