Proximal Humerus Site for Anesthesia

A Study Evaluating Use of the Proximal Humerus Intraosseous Vascular Access Site for Anesthesia Patient Positioning

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.

Study Overview

• Status: Completed
• Conditions: Intraosseous Vascular Access
• Intervention / Treatment: Device: EZ-IO; Device: intraosseous vascular access in the proximal humerus

Detailed Description

When using IO access in the perioperative and OR settings, abduction of the arms to the shoulder level prevents use of the traditional proximal humerus insertion site due to the rotation of the humeral head under the acromion process. An alternate proximal humerus IO insertion technique has been developed to meet the needs of anesthesia patient positioning that uses a slightly more distal insertion site and a superior angle of insertion. However infusion flow rate in the proximal humerus using the anesthesia technique has not been measured. This study is needed to evaluate the anesthesia proximal humerus IO insertion technique to determine if the IO infusion flow rates remain unchanged by the alternate method.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Spring Branch, Texas, United States, 78070
      • Bulverde-Spring Branch EMS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Proximal Humerus Intraosseous Vascular Access - Anesthesia Position; Adult healthy volunteers receiving bilateral proximal humerus intraosseous vascular access while arm is positioned abducted from the body at shoulder level, bilaterally. This arm position is referred to as the "anesthesia position"

Device: EZ-IO; Device: intraosseous vascular access in the proximal humerus; The arm receiving the Intraosseous (IO) needle is positioned with the arm abducted to shoulder level (in position required for surgery), with the arm rotated inward, into the optimal position, with the palms faced down. Deeply palpate the humerus until the junction of the humeral shaft and the humeral head, the surgical neck is identified; the insertion site is in the surgical neck. With the 45mm IO needle placed perpendicular to the plane of the skin, the IO needle is inserted into the surgical neck using a slightly superior angle of insertion and the needle is inserted to the hub. The stylet will be removed and a primed EZ-Connect will be attached to the catheter hub.; Other Names: EZ-IO; Proximal Humerus intraosseous access; IO access; proximal humerus IO access

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraosseous Infusion Flow Rate	the mean infusion flow rate reported in milliliters per hour (mL/hr) obtained at each tested infusion pressure.	Day 1, within 30 minutes of establishing proximal humerus intraosseous (IO) vascular access

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success Rate of Obtaining Laboratory Results for Both Intraosseous and Peripheral Venous Specimens	Number of Participants with Laboratory Results Successfully Obtained from both intraosseous (IO) and peripheral venous blood specimens. Success was determined if the point-of-care laboratory analysis system provided laboratory results values for both IO and Peripheral Venous specimens. It was deemed unsuccessful if the point-of-care system provided no laboratory results values and/or noted an error for at least one specimen. An intraosseous blood specimen and a peripheral venous blood specimen were collected from each subject.	Day 1 within 30 minutes after establishing proximal humerus IO vascular access and peripheral venous access
Time Measured in Seconds for Fluid Delivery From the Proximal Humerus Intraosseous (IO) Site to the Heart	time measured in seconds for fluid delivery from the proximal humerus intraosseous site to the heart, using visualization of contrast injection under fluoroscopy.	Day 1 within 1 hour after establishing proximal humerus intraosseous vascular access

Collaborators and Investigators

• Sponsor: Vidacare Corporation
• Investigators: Principal Investigator: Larry J Miller, MD, Vidacare Corporation

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2013
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: May 28, 2013
• First Submitted That Met QC Criteria: May 30, 2013
• First Posted (Estimated): May 31, 2013

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: March 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: EZ-IO; IO; Intraosseous Vascular Access
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 2013-07