Clinical trial NCT01866475: Continuous Intraosseous Vascular Access Over 48 Hours
Official title: A Study to Determine the Safety of Continuous Intraosseous Vascular Access Over a Period of 48 Hours
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraosseous Vascular Access
Keywords: IO access
Intraosseous vascular access
EZ-IO
Lead sponsor: Teleflex
Sponsor class: INDUSTRY
First posted: 2013-05-31
Enrollment: 127
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 controlled diabetes.

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.

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

Primary outcomes:
measure: Serious Complications From Intraosseous (IO) Access
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: ICON Early Phase Services
state: Texas
Study officials:
affiliation: ICON Early Phase Services
name: Emanuel DeNoia, MD
role: PRINCIPAL_INVESTIGATOR
References: