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

NCT01742780 | Completed Results

• 1 other identifier: 2012-16
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vascular Access

Keywords

Intraosseous Vascular Access; IO Access; IO Vascular Access; EZ-IO

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (6)

Vidacare Method for Intraosseous Insertion

OTHER

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

Saussy Method for Intraosseous Insertion

OTHER

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

Davlantes Method for Intraosseous Insertion

OTHER

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

Campbell Method for Intraosseous Insertion

OTHER

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

Healthy Subjects: Campbell and Saussy Methods

OTHER

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

Healthy Subject: Davlantes and Standard Vidacare Methods

OTHER

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

Interventions

Intraosseous Vascular Access OTHER

Intraosseous vascular access in the proximal humerus.

Campbell Method for Intraosseous Insertion; Davlantes Method for Intraosseous Insertion; Healthy Subject: Davlantes and Standard Vidacare Methods; Healthy Subjects: Campbell and Saussy Methods; Saussy Method for Intraosseous Insertion; Vidacare Method for Intraosseous Insertion

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Vidacare Corporation: lead

Study Sites (1)

Bulverde-Spring Branch EMS

Spring Branch, Texas, 78070, United States

Location

Related Publications (3)

• 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.

  PMID: 21856044 BACKGROUND

• 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.

  PMID: 21275573 BACKGROUND

• 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.

  PMID: 22030185 BACKGROUND

Results Point of Contact

• Title: Thomas Philbeck, PhD, Sr.Director Science and Clinical
• Organization: Vidacare Corporation

Thomas.Philbeck@Vidacare.com

210-375-8500

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: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2012
• First Posted: December 5, 2012
• Study Start: December 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 17, 2026
• Results First Posted: April 17, 2026

Record last verified: 2026-03

Locations

US (1)