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N/A N=127 Randomized Other

Continuous Intraosseous Vascular Access Over 48 Hours

Intraosseous Vascular Access

Enrolled (actual)
127
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Serious Complications From Intraosseous (IO) Access — 0; 0; 0; 0 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
EZ-IO (Device)
Age
Adult, Older Adult · 21+ yrs
Sex
All
Sponsor
Vidacare Corporation
Primary completion
Jul 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Serious Complications From Intraosseous (IO) Access
0; 0; 0; 0

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01866475). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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