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Completed

NCT Number: NCT01853215

Healthy Adult Volunteer Study of Intraosseous Infusion Using the Sternum

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

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bulverde-Spring Branch EMS

Spring Branch, Texas, 78070, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

intraosseous catheter for use in the sternum

Other names: EZ-IO TALON

Primary outcomes

  1. 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

  1. Stability of Locator

    Time frame: 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.

  2. Stability of Catheter Hub

    Time frame: 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.

  3. Adhesion Strips

    Time frame: During insertion of the intraosseous needle set

    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.

  4. Gravity Flow Rates

    Time frame: 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).

  5. 100 Millimeters of Mercury (mmHg) Infusion Flow Rates

    Time frame: 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.

  6. 200 Millimeters of Mercury (mmHg) Infusion Flow Rates

    Time frame: 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.

  7. 300 Millimeters of Mercury (mmHg) Infusion Flow Rates

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Vidacare Corporation

Industry

Registry information

Official study title

A Follow-Up Volunteer Study Evaluating Intraosseous Vascular Access Infusion in the Sternum Using the EZ-IO T.A.L.O.N.Intraosseous System.

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 14, 2013
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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