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

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

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

Study Overview

• Status: Completed
• Conditions: Vascular Access; Intraosseous Vascular Access
• Intervention / Treatment: Device: Intraosseous Vascular Access

Detailed Description

In 2012, the investigators from Vidacare evaluated 4 techniques commonly used to identify the proximal humerus IO insertion site to determine if one technique resulted in more consistent successful placement of the IO needle set with a higher level of confidence among device operators performing the techniques. Results suggest that a combination of the best features of the 4 techniques may lead to optimal IO needle set placement more consistently. This study is needed to validate the "Blended" proximal humerus IO insertion technique to confirm that use of the technique results in proper site identification among device operators and results in increased confidence.To most closely evaluate the Blended proximal humerus insertion technique and how it is received by clinicians who perform these procedures in actual patients, device operators will include licensed/certified clinicians including, emergency medicine technicians/paramedics and nurses.

• Study Type: Interventional
• Enrollment (Actual): 15
• 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:

• 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

Exclusion Criteria for Device Operators: None

Inclusion Criteria Healthy Subjects:

• 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

Exclusion Criteria Health Subjects:

• 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: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Blended Technique for Intraosseous Insertion; 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; Intraossesous Vascular Access in the proximal humerus; Other Names: EZ-IO; IO; Proximal Humerus IO Access
Other: Healthy Subjects: Blended Technique; 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; Intraossesous Vascular Access in the proximal humerus; Other Names: EZ-IO; IO; Proximal Humerus IO Access

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraosseous Infusion Flow Rates	Intraosseous infusion flow rates attained at tested infusion pressures, which may include Gravity; 100 mmHg, 200 mmHg and 300 mmHg.	Day 1 after establishing IO vascular access
Time in Seconds for Fluid Delivery From the Proximal Humerus to the Heart	Time in seconds for fluid delivery from the proximal humerus to the heart, using visualization of contrast injection under fluoroscopy was performed and measured once for the participants in the Healthy Subjects: Blended Technique arm.	Day 1 after IO insertion
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 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): May 14, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: EZ-IO; Intraosseous Vascular Access; IO Access; IO Vascular Access
• Other Study ID Numbers: 2013-06 (AP HM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No