Continuous Intraosseous Vascular Access Over 48 Hours

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Study to Determine the Safety of Continuous Intraosseous Vascular Access Over a Period of 48 Hours

Conditions
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Intraosseous Vascular Access

Intervention / Treatment
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* Device: EZ-IO


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Renal Disease<br>Those with mild to moderate renal disease and had an EZ-IO for 48 hours | Device: EZ-IO<br>* To have an EZ-IO placed up to 48 hours<br>|
| Active Comparator: Diabetes<br>Those with controlled diabetes and had an EZ-IO for 48 hours | Device: EZ-IO<br>* To have an EZ-IO placed up to 48 hours<br>|
| Active Comparator: Renal disease and diabetes<br>Those with both mild to moderate renal disease and controlled diabetes and had an EZ-IO for 48 hours | Device: EZ-IO<br>* To have an EZ-IO placed up to 48 hours<br>|
| Active Comparator: Healthy adults<br>Those who are healthy, defined as lacking co-morbidities that are a study exclusion, and had an EZ-IO for 48 hours | Device: EZ-IO<br>* To have an EZ-IO placed up to 48 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious Complications from intraosseous access | Presence of serious complications from 48 hour intraosseous vascular access using EZ-IO. | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IO access, Intraosseous vascular access, EZ-IO