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

V

Vidacare

Status

Unknown

Conditions

Proximal Humerus Intraosseous Vascular Access

Treatments

Procedure: Proximal Humerus Intraosseous Vascular Access

Study type

Interventional

Funder types

Industry

Identifiers

NCT01742780
2012-16

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

60 participants in 4 patient groups

Standard Vidacare Site Identification Method
Active Comparator group
Description:
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.
Treatment:
Procedure: Proximal Humerus Intraosseous Vascular Access
Saussy Site Identification Method
Active Comparator group
Description:
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.
Treatment:
Procedure: Proximal Humerus Intraosseous Vascular Access
Campbell Site Identification Method
Active Comparator group
Description:
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.
Treatment:
Procedure: Proximal Humerus Intraosseous Vascular Access
Davlantes Site Identification Method
Active Comparator group
Description:
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.
Treatment:
Procedure: Proximal Humerus Intraosseous Vascular Access

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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