Continuous Intraosseous Vascular Access Over 48 Hours
United States127 participantsStarted 2014-11
Plain-language 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.
Who can participate
Age range21 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Serious Complications From Intraosseous (IO) Access