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Healthy Adult Volunteer Study of Intraosseous Infusion Using the Sternum

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01853215
Recruitment Status : Completed
First Posted : May 14, 2013
Results First Posted : October 18, 2013
Last Update Posted : October 18, 2013
Sponsor:
Information provided by (Responsible Party):
Vidacare Corporation

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

Condition or disease Intervention/treatment Phase
Intraosseous Vascular Access Device: T.A.L.O.N. Intraosseous System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official 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.
Study Start Date : April 2013
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Arm Intervention/treatment
Experimental: Sternal intraosseous vascular access
Sternal intraosseous vascular access using T.A.L.O.N. Intraosseous System.
Device: T.A.L.O.N. Intraosseous System
intraosseous catheter for use in the sternum
Other Name: EZ-IO TALON




Primary Outcome Measures :
  1. Occurrences of Extravasation During Infusion [ Time Frame: during 12 minutes of infusion ]
    The number of occurrences of extravasation with intraosseous infusion as evidenced by contrast injection into the intraosseous catheter, visualized under fluoroscopic imaging.


Secondary Outcome Measures :
  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 effeciveness of the device adhesion strips after application. A 1- 5 scale was used with 1=Poor; 2=Fair; 3=Good; $=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. 100mmHg 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. 200mmHg 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. 300mmHg 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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;
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01853215


Locations
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United States, Texas
Bulverde-Spring Branch EMS
Spring Branch, Texas, United States, 78070
Sponsors and Collaborators
Vidacare Corporation
Investigators
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Principal Investigator: Larry J Miller, MD Vidacare Corporation
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Responsible Party: Vidacare Corporation
ClinicalTrials.gov Identifier: NCT01853215    
Other Study ID Numbers: 2013-04
First Posted: May 14, 2013    Key Record Dates
Results First Posted: October 18, 2013
Last Update Posted: October 18, 2013
Last Verified: August 2013
Keywords provided by Vidacare Corporation:
sternal intraosseous infusion study