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Healthy Adult Volunteer Study of Intraosseous Infusion Using the Sternum

NCT ID: NCT01853215

Last Updated: 2013-10-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2013-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Intraosseous Vascular Access

Keywords

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sternal intraosseous infusion study

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Sternal intraosseous vascular access

Sternal intraosseous vascular access using T.A.L.O.N. Intraosseous System.

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

intraosseous catheter for use in the sternum

Interventions

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

intraosseous catheter for use in the sternum

Intervention Type DEVICE

Other Intervention Names

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EZ-IO TALON

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vidacare Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Larry J Miller, MD

Role: PRINCIPAL_INVESTIGATOR

Vidacare Corporation

Locations

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Bulverde-Spring Branch EMS

Spring Branch, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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2013-04

Identifier Type: -

Identifier Source: org_study_id