Status:
COMPLETED
Healthy Adult Volunteer Study of Intraosseous Infusion Using the Sternum
Lead Sponsor:
Vidacare Corporation
Conditions:
Intraosseous Vascular Access
Eligibility:
All Genders
21+ years
Phase:
NA
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 evaluat...
Eligibility Criteria
Inclusion
- 21 years of age or older;
- healthy adult subjects
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01853215
Start Date
April 1 2013
End Date
May 1 2013
Last Update
December 24 2025
Active Locations (1)
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1
Bulverde-Spring Branch EMS
Spring Branch, Texas, United States, 78070