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Evaluation of Various Methods Used to Identify the Proximal Humerus Intraosseous Vascular Access Site

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Vidacare Corporation
ClinicalTrials.gov Identifier:
NCT01742780
First received: November 30, 2012
Last updated: December 3, 2012
Last verified: December 2012
  Purpose

The purpose of this study is to determine if there is one method of identifying the proximal humerus intraosseous vascular access site that is easier for clinicians to use, out of the 4 methods being evaluated.


Condition Intervention
Proximal Humerus Intraosseous Vascular Access
Procedure: Proximal Humerus Intraosseous Vascular Access

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Study Evaluating Insertion Site Identification Methods Used to Establish Intraosseous Vascular Access in the Proximal Humerus

Further study details as provided by Vidacare Corporation:

Primary Outcome Measures:
  • Ease of use score [ Time Frame: Within 10 minutes of procedure ] [ Designated as safety issue: No ]
    Device operators will complete an ease of use questionnaire regarding the assigned site identification method.

  • Level of confidence score [ Time Frame: within 10 minutes of procedure ] [ Designated as safety issue: No ]
    Device operators will complete a level of confidence questionnaire regarding their assigned site identification method.

  • Site identification success/failure [ Time Frame: within 10 minutes of the procedure ] [ Designated as safety issue: No ]
    The ability of the device operator to identify the proximal humerus intraosseous insertion site will be graded as success or failure.

  • Time to intraosseous catheter placement [ Time Frame: within 10 minutes of the procedure ] [ Designated as safety issue: No ]
    The amount of time it takes for the device operator to identify the proximal humerus intraosseous insertion site and insert the needle.


Estimated Enrollment: 60
Study Start Date: December 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard Vidacare Site Identification Method
Palpate up the proximal humerus towards the anterior shoulder just above the surgical neck, to the greater tubercle of the proximal humerus. Insert the needle set perpendicular to skin with a slight downward angle at the most prominent aspect of greater tubercle to establish proximal humerus intraosseous vascular access.
Procedure: Proximal Humerus Intraosseous Vascular Access
EZ-IO Intraosseous Vascular Access System
Other Name: EZ-IO proximal humerus intraosseous vascular access
Active Comparator: Saussy Site Identification Method
Palpate the proximal humerus to locate the intertubercular groove; rotate the forearm medially and laterally to isolate the groove. Move one finger breadth laterally from the groove to the greater tubercle. Insert perpendicular to skin with a slight downward angle to establish proximal humerus intraosseous vascular access.
Procedure: Proximal Humerus Intraosseous Vascular Access
EZ-IO Intraosseous Vascular Access System
Other Name: EZ-IO proximal humerus intraosseous vascular access
Active Comparator: Campbell Site Identification Method
With the fingers on both hands fully extended similar to a karate chop, place one hand into the anterior joint space (acromioclavicular joint) of the patient. Place the second "karate chop" hand along the midline of the patient's lateral shoulder; touch the pinkie fingers over the superior aspect of the patient's shoulder. Overlap the thumbs on the patient's shoulder, which will be at the most prominent aspect of the greater tubercle. Insert the needle set perpendicular to skin with a slight downward angle to establish proximal humerus intraosseous vascular access.
Procedure: Proximal Humerus Intraosseous Vascular Access
EZ-IO Intraosseous Vascular Access System
Other Name: EZ-IO proximal humerus intraosseous vascular access
Active Comparator: Davlantes Site Identification Method
Using one hand, place the thumb on the acromioclavicular joint in the natural recess or "pocket" between the distal clavicle and the humeral head, wrapping the rest of the hand around the upper arm. The hand should be oriented such that the index finger and rest of the hand is at a 90-degree angle to the thumb. The webspace between the thumb and index finger will be approximately where the surgical neck of the humerus is; move one finger breadth (approximately 1 cm) superior. Insert perpendicular to skin with a slight downward angle to establish proximal humerus intraosseous vascular access.
Procedure: Proximal Humerus Intraosseous Vascular Access
EZ-IO Intraosseous Vascular Access System
Other Name: EZ-IO proximal humerus intraosseous vascular access

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria Device Operators:

  • Recent/current experience in the medical field as a practicing clinician.
  • Currently licensed/certified Emergency Medicine Technician, paramedic, or nurse
  • Have had no formal training on use of the proximal humerus intraosseous insertion site.

Exclusion Criteria Device Operators:

There is no exclusion criteria

Inclusion Criteria Healthy Volunteers

  • Age 21 years or older.
  • Has no amputation of the upper extremities.
  • Able to lay flat on table for up to 2 hours.
  • Self-reported as healthy.

Exclusion Criteria Healthy Volunteers:

  • Have an active infection in the body
  • Imprisoned
  • Pregnant
  • Cognitively impaired
  • Fracture in humerus, or significant trauma to the site
  • Excessive tissue and/or absence of adequate anatomical landmarks in humerus
  • Infection in target area
  • Humeral intraosseous insertion in past 48 hours, prosthetic limb or joint or other significant orthopedic procedure in humerus
  • Current use of anti-coagulants
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01742780

Locations
United States, Texas
Bulverde-Spring Branch EMS
Spring Branch, Texas, United States, 78070
Sponsors and Collaborators
Vidacare Corporation
Investigators
Principal Investigator: Larry J Miller, MD Vidacare Corporation