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

Study Overview
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Brief Summary
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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.

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

Conditions
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Proximal Humerus Intraosseous Vascular Access

Intervention / Treatment
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* Procedure: Proximal Humerus Intraosseous Vascular Access


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Vidacare Site Identification Method<br>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. | Procedure: Proximal Humerus Intraosseous Vascular Access<br>* EZ-IO Intraosseous Vascular Access System<br>* Other names: EZ-IO proximal humerus intraosseous vascular access;|
| Active Comparator: Saussy Site Identification Method<br>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. | Procedure: Proximal Humerus Intraosseous Vascular Access<br>* EZ-IO Intraosseous Vascular Access System<br>* Other names: EZ-IO proximal humerus intraosseous vascular access;|
| Active Comparator: Campbell Site Identification Method<br>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. | Procedure: Proximal Humerus Intraosseous Vascular Access<br>* EZ-IO Intraosseous Vascular Access System<br>* Other names: EZ-IO proximal humerus intraosseous vascular access;|
| Active Comparator: Davlantes Site Identification Method<br>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. | Procedure: Proximal Humerus Intraosseous Vascular Access<br>* EZ-IO Intraosseous Vascular Access System<br>* Other names: EZ-IO proximal humerus intraosseous vascular access;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of use score | Device operators will complete an ease of use questionnaire regarding the assigned site identification method. | Within 10 minutes of procedure | 
| Level of confidence score | Device operators will complete a level of confidence questionnaire regarding their assigned site identification method. | within 10 minutes of procedure | 
| Site identification success/failure | The ability of the device operator to identify the proximal humerus intraosseous insertion site will be graded as success or failure. | within 10 minutes of the procedure | 
| Time to intraosseous catheter placement | The amount of time it takes for the device operator to identify the proximal humerus intraosseous insertion site and insert the needle. | within 10 minutes of the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IO Vascular Access, Intraosseous Vascular Access, IO Access, EZ-IO