Follow-Up Study Validating a Blended Technique

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

Detailed Description
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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.

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

Conditions
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Intraosseous Vascular Access

Intervention / Treatment
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* Procedure: Proximal Humerus Intraosseous Vascular Access
* Device: EZ-IO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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: Previous training on establishing proximal humerus intraosseous vascular access

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

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blended Technique<br>Using the blended technique device operators will establish proximal humerus intraosseous vascular access. | Procedure: Proximal Humerus Intraosseous Vascular Access<br>* Using the blended technique, device operators will establish proximal humerus intraosseous vascular access by inserting an IO needle.<br>* Other names: IO;Device: EZ-IO<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful IO insertion | Successful IO needle insertion determined by x-ray images | Day 1 after establishing proximal humerus IO vascular access | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraosseous Infusion flow rates | Intraosseous infusion flow rates attained using 4 different infusion pressures 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, using visualization of contrast injection under fluoroscopy. |  | Day 1 after IO insertion | 
| Relationship between IO and peripheral venous blood | IO blood and peripheral venous blood will be collected and analyzed for routine blood tests and the results will be compared to determine if there is a relationship. | Day 1 after establishing IO vascular access and peripheral venous access | 

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