N/A
Completed N=15
Follow-Up Study Validating a Blended Technique to Identify the Proximal Humerus Intraosseous Vascular Access Site
Intraosseous Vascular Access · Vascular Access
Source: ClinicalTrials.gov NCT01866501 ↗
Enrolled (actual)
15
Serious AEs
0.0%
Results posted
May 2026
Primary outcomePrimary: Proximal Humerus Intraosseous (IO) Insertion Site Placement Total Score — 6.0; 1.2; 4.8 units on a scale
Summary
A Follow-up Study Validating a Blended Technique for Identifying the Proximal Humerus Intraosseous Vascular Access Insertion Site
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proximal Humerus Intraosseous (IO) Insertion Site Placement Total Score |
6.0; 1.2; 4.8 | — |
| PRIMARY Time to Intraosseous Catheter Placement |
178.0 | — |
| PRIMARY Level of Confidence Score Pre-intraosseous Insertion |
3.22 | — |
| PRIMARY Level of Confidence Score Post-intraosseous Insertion |
4.1 | — |
| PRIMARY Ease of Use Score Pre-intraosseous Insertion |
4.11 | — |
| PRIMARY Ease of Use Score Post-intraosseous Insertion |
4.5 | — |
| SECONDARY Intraosseous Infusion Flow Rates |
— | — |
| SECONDARY Time in Seconds for Fluid Delivery From the Proximal Humerus to the Heart |
2.44 | — |
| SECONDARY Success Rate of Obtaining Laboratory Results for Both Intraosseous and Peripheral Venous Specimens |
4 | — |
Eligibility Criteria
Inclusion Criteria Device Operators:
- Currently licensed/certified Emergency Medicine Technicians, paramedic, or nurse
- Have had no formal training on use of the proximal humerus IO insertion site
- Demonstrate proper use of the device and technique during training portion and obtain approval from the device trainer to participate
Exclusion Criteria for Device Operators: None
Inclusion Criteria Healthy Subjects:
- Age 21 years or older
- Have no amputation of the upper extremities
- Able to lay flat on a table for up to 2 hours
- Self-reported as healthy, as confirmed by the PI
Exclusion Criteria Health Subjects:
- 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 (NCT01866501). 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. Informational only — not medical advice.