Evaluation of Various Methods Used to Identify the Proximal Humerus Intraosseous Vascular Access Site

A Study Evaluating Insertion Site Identification Methods Used to Establish Intraosseous Vascular Access in the Proximal Humerus

The purpose of this study is to determine if there is one method of identifying the proximal humerus intraosseous vascular access site that is easier for clinicians to use, out of the 4 methods being evaluated.

Study Overview

• Status: Completed
• Conditions: Vascular Access
• Intervention / Treatment: Other: Intraosseous Vascular Access

Detailed Description

This was a non-controlled study using licensed/certified EMT/paramedics and licensed nurses as device operator subjects identifying the proximal humerus IO insertion site and inserting the IO catheter in healthy adult volunteers. Forty (40) clinicians with no prior training on establishing IO vascular access in the proximal humerus IO insertion site were enrolled in the study as device operator subjects. Twenty (20) healthy adult volunteers were enrolled in the study to have IO vascular access established bilaterally in the proximal humerus with one device operator accessing one of the subject's arms, according to their assigned method for identifying the proximal humerus intraosseous vascular access site.

• Study Type: Interventional
• Enrollment (Actual): 60
• 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 Device Operators:

• Recent/current experience in the medical field as a practicing clinician.
• Currently licensed/certified Emergency Medicine Technician, paramedic, or nurse
• Have had no formal training on use of the proximal humerus intraosseous insertion site.

Exclusion Criteria Device Operators:

There is no exclusion criteria

Inclusion Criteria Healthy Volunteers

• Age 21 years or older.
• Has no amputation of the upper extremities.
• Able to lay flat on table for up to 2 hours.
• Self-reported as healthy.

Exclusion Criteria Healthy Volunteers:

• 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 intraosseous insertion in past 48 hours, prosthetic limb or joint or other significant orthopedic procedure in humerus
• Current use of anti-coagulants

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Vidacare Method for Intraosseous Insertion; Clinicians with no prior training on identifying the proximal humerus IO insertion site to be trained on the Standard Vidacare Method site identification method and perform one unilateral proximal humerus IO needle insertion. The Standard Vidacare Method description is: Palpate up the proximal humerus towards the anterior shoulder just above the surgical neck, to the greater tubercle of the proximal humerus. Insert the needle set perpendicular to skin with a slight downward angle at the most prominent aspect of greater tubercle to establish proximal humerus intraosseous vascular access. Intraosseous Vascular Access.	Other: Intraosseous Vascular Access; Intraosseous vascular access in the proximal humerus.
Other: Saussy Method for Intraosseous Insertion; Clinicians with no prior training in identifying the proximal humerus IO insertion site to be trained on the Saussy Method site identification method and perform one unilateral proximal humerus IO needle insertion. The Saussy Method description is: Palpate the proximal humerus to locate the intertubercular groove; rotate the forearm medially and laterally to isolate the groove. Move one finger breadth laterally from the groove to the greater tubercle. Insert perpendicular to skin with a slight downward angle to establish proximal humerus intraosseous vascular access. Intraosseous Vascular Access	Other: Intraosseous Vascular Access; Intraosseous vascular access in the proximal humerus.
Other: Davlantes Method for Intraosseous Insertion; Clinicians with no prior training in identifying the proximal humerus IO insertion site to be trained on the Davlantes Method site identification method and perform one unilateral proximal humerus IO needle insertion. The description of the Davlantes Method is: Using one hand, place the thumb on the acromioclavicular joint in the natural recess or "pocket" between the distal clavicle and the humeral head, wrapping the rest of the hand around the upper arm. The hand should be oriented such that the index finger and rest of the hand is at a 90-degree angle to the thumb. The webspace between the thumb and index finger will be approximately where the surgical neck of the humerus is; move one finger breadth (approximately 1 cm) superior. Insert perpendicular to skin with a slight downward angle to establish proximal humerus intraosseous vascular access. Intraosseous Vascular Access	Other: Intraosseous Vascular Access; Intraosseous vascular access in the proximal humerus.
Other: Campbell Method for Intraosseous Insertion; Clinicians with no prior training in identifying the proximal humerus IO insertion site to be trained on the Campbell Method site identification method and perform one unilateral proximal humerus IO needle insertion. The Campbell Method description is: With the fingers on both hands fully extended similar to a karate chop, place one hand into the anterior joint space (acromioclavicular joint) of the patient. Place the second "karate chop" hand along the midline of the patient's lateral shoulder; touch the pinkie fingers over the superior aspect of the patient's shoulder. Overlap the thumbs on the patient's shoulder, which will be at the most prominent aspect of the greater tubercle. Insert the needle set perpendicular to skin with a slight downward angle to establish proximal humerus intraosseous vascular access. Intraosseous Vascular Access	Other: Intraosseous Vascular Access; Intraosseous vascular access in the proximal humerus.
Other: Healthy Subjects: Campbell and Saussy Methods; Healthy Subjects received bilateral intraosseous (IO) vascular access in the proximal humerus by device operators using the Saussy Method on one proximal humerus and the Campbell method on the other proximal humerus.	Other: Intraosseous Vascular Access; Intraosseous vascular access in the proximal humerus.
Other: Healthy Subject: Davlantes and Standard Vidacare Methods; Subjects received bilateral intraosseous (IO) vascular access in the proximal humerus by device operators using the Davlantes Method on one proximal humerus and the Standard Vidacare method on the other proximal humerus.	Other: Intraosseous Vascular Access; Intraosseous vascular access in the proximal humerus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ease of Use Score	Device operators will score their perceived Ease of Use for their assigned Intraosseous Insertion method for their one unilateral proximal humerus IO site procedure. The Ease of Use scale scores range from 0 to 10, where 0=extremely difficult and 10=extremely easy. Higher scores indicate greater ease of use.	Within 10 minutes of procedure
Level of Confidence Score	Device operators scored their perceived Level of Confidence with their assigned Intraosseous Insertion method for their one unilateral proximal humerus IO site procedure. The Level of Confidence scale scores range from 0 to 10, where. 0=no confidence and 10=extremely confident. Higher scores indicate greater level of confidence.	within 10 minutes of procedure
Proximal Humerus Intraosseous (IO) Insertion Site Placement Score	The ability of the device operator to insert the Intraosseous device into the "ideal target area" was scored using an accuracy scoring scale. The "ideal target area" was defined as the center of the greater tubercle. The following scoring scale ranging from 0 to 3 was used. 3= center of the greater tubercle; 2=sightly off-center of the greater tubercle, 1=borderline of the greater tubercle, and 0=completely outside the greater tubercle. Higher scores indicate better insertion position.	within 10 minutes of the procedure
Time to Intraosseous (IO) Catheter Placement	The amount of time it takes for the device operator to identify the proximal humerus intraosseous (IO) insertion site using their assigned proximal humerus IO site identification method and insert the IO needle Timing starts from the time the participant begins to palpate the proximal humerus and stops when the IO needle is inserted.	within 10 minutes of the procedure

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Reades R, Studnek JR, Vandeventer S, Garrett J. Intraosseous versus intravenous vascular access during out-of-hospital cardiac arrest: a randomized controlled trial. Ann Emerg Med. 2011 Dec;58(6):509-16. doi: 10.1016/j.annemergmed.2011.07.020.
• Reades R, Studnek JR, Garrett JS, Vandeventer S, Blackwell T. Comparison of first-attempt success between tibial and humeral intraosseous insertions during out-of-hospital cardiac arrest. Prehosp Emerg Care. 2011 Apr-Jun;15(2):278-81. doi: 10.3109/10903127.2010.545479. Epub 2011 Jan 28.
• Wampler D, Schwartz D, Shumaker J, Bolleter S, Beckett R, Manifold C. Paramedics successfully perform humeral EZ-IO intraosseous access in adult out-of-hospital cardiac arrest patients. Am J Emerg Med. 2012 Sep;30(7):1095-9. doi: 10.1016/j.ajem.2011.07.010. Epub 2011 Oct 24.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: November 30, 2012
• First Submitted That Met QC Criteria: December 3, 2012
• First Posted (Estimated): December 5, 2012

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: March 29, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: EZ-IO; Intraosseous Vascular Access; IO Access; IO Vascular Access
• Other Study ID Numbers: 2012-16