Proximal Humerus Site for Anesthesia

NCT01866514 | Completed Results

• 1 other identifier: 2013-07
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intraosseous Vascular Access

Keywords

EZ-IO; IO; Intraosseous Vascular Access

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Success Rate of Obtaining Laboratory Results for Both Intraosseous and Peripheral Venous Specimens

  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

  Day 1 within 1 hour after establishing proximal humerus intraosseous vascular access

Study Arms (1)

Proximal Humerus Intraosseous Vascular Access - Anesthesia Position

EXPERIMENTAL

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: intraosseous vascular access in the proximal humerus; Device: EZ-IO

Interventions

EZ-IO DEVICE

Proximal Humerus Intraosseous Vascular Access - Anesthesia Position

intraosseous vascular access in the proximal humerus DEVICE

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.

Also known as: EZ-IO, Proximal Humerus intraosseous access, IO access, proximal humerus IO access

Proximal Humerus Intraosseous Vascular Access - Anesthesia Position

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vidacare Corporation: lead

Study Sites (1)

Bulverde-Spring Branch EMS

Spring Branch, Texas, 78070, United States

Location

Results Point of Contact

• Title: Tatiana Puga
• Organization: Teleflex

tatiana.puga@teleflex.com

Study Officials

• Larry J Miller, MD

  Vidacare Corporation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2013
• First Posted: May 31, 2013
• Study Start: May 1, 2013
• Primary Completion: May 1, 2013
• Study Completion: June 1, 2013
• Last Updated: April 17, 2026
• Results First Posted: April 17, 2026

Record last verified: 2026-01

Locations

US (1)