Status:
COMPLETED
Continuous Intraosseous Vascular Access Over 48 Hours
Lead Sponsor:
Vidacare Corporation
Conditions:
Intraosseous Vascular Access
Eligibility:
All Genders
21+ years
Phase:
NA
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 c...
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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT01866475
Start Date
November 1 2014
End Date
July 1 2016
Last Update
April 9 2024
Active Locations (1)
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1
ICON Early Phase Services
San Antonio, Texas, United States, 78209