Healthy Adult Volunteer Study of Intraosseous Infusion Using the Sternum

Vidacare

Status

Completed

Conditions

Intraosseous Vascular Access

Treatments

Device: T.A.L.O.N. Intraosseous System

Study type

Interventional

Funder types

Industry

Identifiers

NCT01853215

2013-04

Details and patient eligibility

About

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

Full 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.

Enrollment

24 patients

Sex

All

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

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