Healthy Adult Volunteer Study of Intraosseous Infusion Using the Sternum

Study Overview
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Brief Summary
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This study is being done to evaluate intraosseous vascular access through the sternum.

Detailed Description
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The purpose of this study is to evaluate the presence or absence of extravasation when using the T.A.L.O.N. Intraosseous System to establish sternal intraosseous infusion. This study will also evaluate the user preference feedback received from the device operators about the ease of use and level of satisfaction with the device. Lastly, this study will evaluate the infusion flow rates obtained when using intraosseous infusion in the sternum.

Official Title
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A Follow-Up Volunteer Study Evaluating Intraosseous Vascular Access Infusion in the Sternum Using the EZ-IO T.A.L.O.N.Intraosseous System.

Conditions
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Intraosseous Vascular Access

Intervention / Treatment
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* Device: T.A.L.O.N. Intraosseous System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 21 years of age or older; healthy adult subjects Exclusion Criteria: Weight < 45kg; BMI greater or equal to 30 with absence of adequate landmarks or too much overlaying tissue, as determined by the PI; Imprisoned subjects; pregnant subjects; prior sternotomy; cognitively impaired subjects; fracture in target bone, or significant trauma to the site; excessive tissue and/or absence of adequate anatomical landmarks in target bone; infection in target area; IO insertion in past 48 hours or other significant orthopedic procedure in target bone; current use of anti-coagulants; previous adverse reaction to Lidocaine; current cardiac condition requiring pacemaker or anti-arrhythmic drugs previous adverse reaction to contrast dye Allergy to any food and drug History of impaired renal function History of impaired hepatic function History of cardiac disease History of pheochromocytoma

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: Sternal intraosseous vascular access<br>Sternal intraosseous vascular access using T.A.L.O.N. Intraosseous System. | Device: T.A.L.O.N. Intraosseous System<br>* intraosseous catheter for use in the sternum<br>* Other names: EZ-IO TALON;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrences of Extravasation During Infusion | The number of occurrences of extravasation with intraosseous infusion as evidenced by contrast injection into the intraosseous catheter, visualized under fluoroscopic imaging. | during 12 minutes of infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stability of Locator | Operator's perceived stability of the sternal locator once placed on the subject. 1 to 5 scale was used with 1=Poor; 2=Fair; 3=Good; 4=Very good; 5=Excellent. | During insertion of the intraosseous needle set | 
| Stability of Catheter Hub | Ability to stabilize the catheter hub and rotate the stylet for removal. 1 to 5 scale was used with 1=Very difficult; 2-Difficult; 3=Neutral; 4=Easy; 5=Very easy. | During insertion of the intraosseous needle set | 
| Adhesion Strips | Perceived effeciveness of the device adhesion strips after application. A 1- 5 scale was used with 1=Poor; 2=Fair; 3=Good; $=Very good; 5=Excellent. | During insertion of the intraosseous needle set | 
| Gravity Flow Rates | Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a gravity infusion (no Pressure). | during the 12 minute infusion time frame | 
| 100mmHg Infusion Flow Rates | Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a 100 mmHg infusion. | during the 12 minute infusion time frame | 
| 200mmHg Infusion Flow Rates | Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a 200 mmHg infusion. | during the 12 minute infusion time frame | 
| 300mmHg Infusion Flow Rates | Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a 300 mmHg infusion. | during the 12 minute infusion time frame | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sternal intraosseous infusion study