Continuous Intraosseous Vascular Access Over 48 Hours

A Study to Determine the Safety of Continuous Intraosseous Vascular Access Over a Period of 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 mild to moderate renal disease and/or controlled diabetes.

Study Overview

• Status: Completed
• Conditions: Intraosseous Vascular Access
• Intervention / Treatment: Device: EZ-IO

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.

• Study Type: Interventional
• Enrollment (Actual): 127
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78209
      • ICON Early Phase Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Renal Disease; Those with mild to moderate renal disease and had an EZ-IO for 48 hours	Device: EZ-IO; To have an EZ-IO placed up to 48 hours
Active Comparator: Diabetes; Those with controlled diabetes and had an EZ-IO for 48 hours	Device: EZ-IO; To have an EZ-IO placed up to 48 hours
Active Comparator: Renal disease and diabetes; Those with both mild to moderate renal disease and controlled diabetes and had an EZ-IO for 48 hours	Device: EZ-IO; To have an EZ-IO placed up to 48 hours
Active Comparator: Healthy adults; 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; To have an EZ-IO placed up to 48 hours

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Vidacare Corporation
• Investigators: Principal Investigator: Emanuel DeNoia, MD, ICON Early Phase Services

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2014
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: May 28, 2013
• First Submitted That Met QC Criteria: May 28, 2013
• First Posted (Estimated): May 31, 2013

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: EZ-IO; IO access; Intraosseous vascular access
• Other Study ID Numbers: 2011-16