Healthy Adult Volunteer Study of Intraosseous Infusion Using the Sternum

Vidacare Corporation24 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Intraosseous Vascular Access

Interventions

T.A.L.O.N. Intraosseous SystemDEVICE

intraosseous catheter for use in the sternum

Eligibility

Sex: ALLMin age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Bulverde-Spring Branch EMS

Spring Branch, Texas, United States

Outcomes

Primary Outcomes

Occurrences of Extravasation During 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.

Time frame: during 12 minutes of infusion

Secondary Outcomes

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.

Time frame: 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.

Time frame: During insertion of the intraosseous needle set

Adhesion Strips

Perceived effectiveness of the device adhesion strips after application. A 1- 5 scale was used with 1=Poor; 2=Fair; 3=Good; 4=Very good; 5=Excellent.

Time frame: 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).

Time frame: during the 12 minute infusion time frame

100 Millimeters of Mercury (mmHg) Infusion Flow Rates

Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a 100 mmHg infusion.

Time frame: during the 12 minute infusion time frame

Data from ClinicalTrials.gov

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