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

Not Applicable

• Conditions: Proximal Humerus Intraosseous Vascular Access
• Interventions: Procedure: Proximal Humerus Intraosseous Vascular Access

• Registration Number: NCT01742780
• Lead Sponsor: Vidacare Corporation

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2012-11-30
• Status Verified: 2012-12
• Study Start: 2012-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted QC: 2012-12-03
• Last Update Submitted: 2012-12-03
• Study First Posted: 2012-12-05
• Last Update Posted: 2012-12-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Davlantes Site Identification Method	Proximal Humerus Intraosseous Vascular Access	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.
Saussy Site Identification Method	Proximal Humerus Intraosseous Vascular Access	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.
Campbell Site Identification Method	Proximal Humerus Intraosseous Vascular Access	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.
Standard Vidacare Site Identification Method	Proximal Humerus Intraosseous Vascular Access	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.

Primary Outcome Measures

Name	Time	Method
Ease of use score	Within 10 minutes of procedure	Device operators will complete an ease of use questionnaire regarding the assigned site identification method.
Level of confidence score	within 10 minutes of procedure	Device operators will complete a level of confidence questionnaire regarding their assigned site identification method.
Site identification success/failure	within 10 minutes of the procedure	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	within 10 minutes of the procedure	The amount of time it takes for the device operator to identify the proximal humerus intraosseous insertion site and insert the needle.

Trial Locations

Locations (1)

Bulverde-Spring Branch EMS; 🇺🇸 Spring Branch, Texas, United States