Follow-Up Study Validating a Blended Technique to Identify the Proximal Humerus Intraosseous Vascular Access Site

NCT01866501 | Completed Results FDA Device

• 1 other identifier: 2013-06
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

A Follow-up Study Validating a Blended Technique for Identifying the Proximal Humerus Intraosseous Vascular Access Insertion Site

Conditions

Vascular Access; Intraosseous Vascular Access

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Proximal Humerus Intraosseous (IO) Insertion Site Placement Total Score

  X-ray images of the inserted IO needle will be used to evaluate placement success and scored. Each insertion is scored by a musculoskeletal radiologist for two measures: Insertion Site Accuracy (scale range 0 - 3) and Needle Tip Location (scale range -7 to 7) as described below. The Total score is the sum of Insertion Site Accuracy Score and Needle Tip Location Score. Scale range -7 to 10; higher score indicates greater accuracy. Insertion Site Accuracy Score Scale is 0 to 3 where higher scores indicate greater accuracy: 3=center of greater tubercle, 2=perimeter of greater tubercle, 1=junction of greater tubercle and shaft or head, and 0=outside the greater tubercle. Needle tip Location Score Scale ranges from -7 to 7 where higher scores indicate more favorable needle tip location: 7=within center of proximal humerus (PH), 5=within PH not centered, 3= Near miss of PH, -3=In humeral head, -3=on epiphyseal line, -5=lateral miss (of the humerus), -7=medial miss (of the humerus).

  Day 1 Within 10 minutes following procedure

• Time to Intraosseous 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.

  1 day, within 10 minutes of procedure

• Level of Confidence Score Pre-intraosseous Insertion

  Device operators scored their perceived Level of Confidence with their assigned Intraosseous (IO) Insertion method. The score was reported following the completion of training but before performing the unilateral IO insertion. The Level of Confidence scale scores range from 1 to 5, where. 1=not at all confident, 2=slightly confident, 3=moderately confident, 4=very confident, and 5=extremely confident. Higher scores indicate greater level of confidence.

  Day 1 within 10 minutes of completing training

• Level of Confidence Score Post-intraosseous Insertion

  Device operators scored their perceived Level of Confidence with their assigned Intraosseous (IO) Insertion method for their one unilateral proximal humerus IO site procedure. The score was reported after performing the unilateral IO insertion. The Level of Confidence scale scores range from 1 to 5, where. 1=not at all confident, 2=slightly confident, 3=moderately confident, 4=very confident, and 5=extremely confident. Higher scores indicate greater level of confidence.

  Day 1 within 10 minutes of completing the unilateral intraosseous insertion

• Ease of Use Score Pre-intraosseous Insertion

  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 score was reported following the completion of training but before performing the unilateral IO insertion. The Ease of Use scale scores range from 1 to 5, where 1=very difficult, 2=difficult, 3=neutral, 4=easy, and 5=very easy. Higher scores indicate greater ease of use.

  Day 1 within 10 minutes of completing the unilateral intraosseous insertion

• Ease of Use Score Post-intraosseous Insertion

  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 score was reported after completing the unilateral intraosseous insertion. The Ease of Use scale scores range from 1 to 5, where 1=very difficult, 2=difficult, 3=neutral, 4=easy, and 5=very easy. Higher scores indicate greater ease of use.

  Day 1 within 10 minutes of completing the unilateral insertion

Secondary Outcomes (3)

• Intraosseous Infusion Flow Rates

  Day 1 after establishing IO vascular access

• Time in Seconds for Fluid Delivery From the Proximal Humerus to the Heart

  Day 1 after IO insertion

• 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

Study Arms (2)

Blended Technique for Intraosseous Insertion

OTHER

Clinician device operators will be trained on the Blended Technique site identification method and perform one unilateral proximal humerus (PH) intraosseous needle insertion. The blended technique is: The arm is positioned with the elbow adducted and shoulder internally rotated with the hand over the abdomen. The operator places one hand in the axilla and the other hand along the midline of the upper arm laterally, to define the anterior and posterior borders. The vertical plane of insertion lies in the middle of these borders. Along the vertical axis, deeply palpate the PH until the junction of the surgical neck and humeral head is identified. The insertion site is the greater tubercle, about 1-2 cm superior to the surgical neck. Secondary confirmation is made by palpating the inter-tubercular groove with a 90º rotation of the arm, confirming the insertion site is lateral to the groove, and returning the arm back to a medially rotated position with the hand over the abdomen

Device: Intraosseous Vascular Access

Healthy Subjects: Blended Technique

OTHER

Healthy subjects will receive bilateral intraosseous vascular access established in the proximal humerus performed by device operators using the blended technique.

Device: Intraosseous Vascular Access

Interventions

Intraosseous Vascular Access DEVICE

Intraossesous Vascular Access in the proximal humerus

Also known as: EZ-IO, Proximal Humerus IO Access, IO

Blended Technique for Intraosseous Insertion; Healthy Subjects: Blended Technique

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

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: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• 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: May 1, 2013
• Last Updated: May 14, 2026
• Results First Posted: May 14, 2026

Record last verified: 2013-05

Locations

US (1)