N/A
N=5
Proximal Humerus Site for Anesthesia
Intraosseous Vascular Access
Bottom Line
View on ClinicalTrials.gov: NCT01866514 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Intraosseous Infusion Flow Rate — 2433.33 mL / hour
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- intraosseous vascular access in the proximal humerus (Device); EZ-IO (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Vidacare Corporation
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraosseous Infusion Flow Rate |
2433.33 | — |
| SECONDARY Success Rate of Obtaining Laboratory Results for Both Intraosseous and Peripheral Venous Specimens |
5 | — |
| SECONDARY Time Measured in Seconds for Fluid Delivery From the Proximal Humerus Intraosseous (IO) Site to the Heart |
2.07 | — |
Summary
This will be a prospective, non-controlled study using healthy adult volunteers as subjects receiving bilateral proximal humerus intraosseous (IO) vascular access to evaluate the insertion technique and IO infusion flow rates.
Eligibility Criteria
Inclusion Criteria
- Age 21 years or older
- Have no amputation of the upper extremities
- Able to lay flat on table for up to 2 hours
- Self-reported as healthy, as confirmed by the PI
Exclusion Criteria
- Have an active infection in the body
- Imprisoned
- Pregnant
- Cognitively impaired
- Fracture in humerus, or significant trauma to the site
- Excessive tissue and/or absence of adequate anatomical landmarks in humerus
- Infection in target area
- Humeral IO insertion in past 48 hours, prosthetic limb or joint or other significant orthopedic procedure in humerus
- Current use of anti-coagulants
- Current cardiac condition requiring pacemaker or anti-arrhythmic drugs
- Prior adverse reaction to lidocaine
- Volunteers with any of the following characteristics may be excluded from the infusion pathway evaluation involving administration of contrast dye at the discretion of the PI:
- Prior adverse reaction to contrast dye
- Allergy to any food or drug
- History of impaired renal function
- History of impaired hepatic function
- History of cardiac disease
- History of pheochromocytoma
Data sourced from ClinicalTrials.gov (NCT01866514). 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.