- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01853215
Healthy Adult Volunteer Study of Intraosseous Infusion Using the Sternum
August 9, 2013 updated by: Vidacare Corporation
A Follow-Up Volunteer Study Evaluating Intraosseous Vascular Access Infusion in the Sternum Using the EZ-IO T.A.L.O.N.Intraosseous System.
This study is being done to evaluate intraosseous vascular access through the sternum.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Spring Branch, Texas, United States, 78070
- Bulverde-Spring Branch EMS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Sternal intraosseous vascular access
Sternal intraosseous vascular access using T.A.L.O.N.
Intraosseous System.
|
intraosseous catheter for use in the sternum
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
during 12 minutes of infusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
During insertion of the intraosseous needle set
|
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.
|
During insertion of the intraosseous needle set
|
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.
|
During insertion of the intraosseous needle set
|
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).
|
during the 12 minute infusion time frame
|
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.
|
during the 12 minute infusion time frame
|
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.
|
during the 12 minute infusion time frame
|
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.
|
during the 12 minute infusion time frame
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (ACTUAL)
May 1, 2013
Study Completion (ACTUAL)
May 1, 2013
Study Registration Dates
First Submitted
May 9, 2013
First Submitted That Met QC Criteria
May 13, 2013
First Posted (ESTIMATE)
May 14, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
October 18, 2013
Last Update Submitted That Met QC Criteria
August 9, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2013-04 (Other Identifier: Assistance Publique Hôpitaux de Marseille)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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