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

NCT ID: NCT01742780

Last Updated: 2012-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Proximal Humerus Intraosseous Vascular Access

Keywords

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Intraosseous Vascular Access IO Access IO Vascular Access EZ-IO

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Proximal Humerus Intraosseous Vascular Access

Intervention Type PROCEDURE

EZ-IO Intraosseous Vascular Access System

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.

Group Type ACTIVE_COMPARATOR

Proximal Humerus Intraosseous Vascular Access

Intervention Type PROCEDURE

EZ-IO Intraosseous Vascular Access System

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.

Group Type ACTIVE_COMPARATOR

Proximal Humerus Intraosseous Vascular Access

Intervention Type PROCEDURE

EZ-IO Intraosseous Vascular Access System

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.

Group Type ACTIVE_COMPARATOR

Proximal Humerus Intraosseous Vascular Access

Intervention Type PROCEDURE

EZ-IO Intraosseous Vascular Access System

Interventions

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Proximal Humerus Intraosseous Vascular Access

EZ-IO Intraosseous Vascular Access System

Intervention Type PROCEDURE

Other Intervention Names

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EZ-IO proximal humerus intraosseous vascular access

Eligibility Criteria

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Inclusion Criteria

* 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.


* 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

* 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
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

References

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Reades R, Studnek JR, Vandeventer S, Garrett J. Intraosseous versus intravenous vascular access during out-of-hospital cardiac arrest: a randomized controlled trial. Ann Emerg Med. 2011 Dec;58(6):509-16. doi: 10.1016/j.annemergmed.2011.07.020.

Reference Type BACKGROUND
PMID: 21856044 (View on PubMed)

Reades R, Studnek JR, Garrett JS, Vandeventer S, Blackwell T. Comparison of first-attempt success between tibial and humeral intraosseous insertions during out-of-hospital cardiac arrest. Prehosp Emerg Care. 2011 Apr-Jun;15(2):278-81. doi: 10.3109/10903127.2010.545479. Epub 2011 Jan 28.

Reference Type BACKGROUND
PMID: 21275573 (View on PubMed)

Wampler D, Schwartz D, Shumaker J, Bolleter S, Beckett R, Manifold C. Paramedics successfully perform humeral EZ-IO intraosseous access in adult out-of-hospital cardiac arrest patients. Am J Emerg Med. 2012 Sep;30(7):1095-9. doi: 10.1016/j.ajem.2011.07.010. Epub 2011 Oct 24.

Reference Type BACKGROUND
PMID: 22030185 (View on PubMed)

Other Identifiers

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2012-16

Identifier Type: -

Identifier Source: org_study_id