A Follow-Up Volunteer Study Evaluating Intraosseous Vascular Access Infusion in the Sternum Using the EZ-IO T.A.L.O.N.Intraosseous System.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Intraosseous Vascular Access
- Sponsor
- Vidacare Corporation
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Occurrences of Extravasation During Infusion
- Status
- Completed
- Last Updated
- 4 months ago
Overview
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.
Investigators
Eligibility Criteria
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;
Outcomes
Primary Outcomes
Occurrences of Extravasation During Infusion
Time Frame: during 12 minutes of infusion
The number of participants with occurrence of extravasation during intraosseous infusion as evidenced by contrast injection into the intraosseous catheter, visualized under fluoroscopic imaging.
Secondary Outcomes
- Stability of Locator(During insertion of the intraosseous needle set)
- Adhesion Strips(During insertion of the intraosseous needle set)
- Stability of Catheter Hub(During insertion of the intraosseous needle set)
- Gravity Flow Rates(during the 12 minute infusion time frame)
- 100 Millimeters of Mercury (mmHg) Infusion Flow Rates(during the 12 minute infusion time frame)
- 200 Millimeters of Mercury (mmHg) Infusion Flow Rates(during the 12 minute infusion time frame)
- 300 Millimeters of Mercury (mmHg) Infusion Flow Rates(during the 12 minute infusion time frame)