Healthy Adult Volunteer Study of Intraosseous Infusion Using the Sternum

Not Applicable

Completed

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

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Primary Outcome Measures

Name	Time	Method
Occurrences of Extravasation During Infusion	during 12 minutes of infusion	The number of occurrences of extravasation with intraosseous infusion as evidenced by contrast injection into the intraosseous catheter, visualized under fluoroscopic imaging.

Secondary Outcome Measures

Name	Time	Method
Gravity Flow Rates	during the 12 minute infusion time frame	Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a gravity infusion (no Pressure).
100mmHg Infusion Flow Rates	during the 12 minute infusion time frame	Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a 100 mmHg infusion.
200mmHg Infusion Flow Rates	during the 12 minute infusion time frame	Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a 200 mmHg infusion.
300mmHg Infusion Flow Rates	during the 12 minute infusion time frame	Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a 300 mmHg infusion.
Stability of Locator	During insertion of the intraosseous needle set	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.
Stability of Catheter Hub	During insertion of the intraosseous needle set	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.
Adhesion Strips	During insertion of the intraosseous needle set	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.