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

Vidacare Corporation60 enrolled

Overview

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.

This was a non-controlled study using licensed/certified EMT/paramedics and licensed nurses as device operator subjects identifying the proximal humerus IO insertion site and inserting the IO catheter in healthy adult volunteers. Forty (40) clinicians with no prior training on establishing IO vascular access in the proximal humerus IO insertion site were enrolled in the study as device operator subjects. Twenty (20) healthy adult volunteers were enrolled in the study to have IO vascular access established bilaterally in the proximal humerus with one device operator accessing one of the subject's arms, according to their assigned method for identifying the proximal humerus intraosseous vascular access site.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Vascular Access

Interventions

Intraosseous Vascular AccessOTHER

Intraosseous vascular access in the proximal humerus.

Eligibility

Sex: ALLMin age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Bulverde-Spring Branch EMS

Spring Branch, Texas, United States

Outcomes

Primary Outcomes

Ease of Use Score

Device operators will score their perceived Ease of Use for their assigned Intraosseous Insertion method for their one unilateral proximal humerus IO site procedure. The Ease of Use scale scores range from 0 to 10, where 0=extremely difficult and 10=extremely easy. Higher scores indicate greater ease of use.

Time frame: Within 10 minutes of procedure

Level of Confidence Score

Device operators scored their perceived Level of Confidence with their assigned Intraosseous Insertion method for their one unilateral proximal humerus IO site procedure. The Level of Confidence scale scores range from 0 to 10, where. 0=no confidence and 10=extremely confident. Higher scores indicate greater level of confidence.

Time frame: within 10 minutes of procedure

Proximal Humerus Intraosseous (IO) Insertion Site Placement Score

The ability of the device operator to insert the Intraosseous device into the "ideal target area" was scored using an accuracy scoring scale. The "ideal target area" was defined as the center of the greater tubercle. The following scoring scale ranging from 0 to 3 was used. 3= center of the greater tubercle; 2=sightly off-center of the greater tubercle, 1=borderline of the greater tubercle, and 0=completely outside the greater tubercle. Higher scores indicate better insertion position.

Time frame: within 10 minutes of the procedure

Time to Intraosseous (IO) Catheter Placement

The amount of time it takes for the device operator to identify the proximal humerus intraosseous (IO) insertion site using their assigned proximal humerus IO site identification method and insert the IO needle Timing starts from the time the participant begins to palpate the proximal humerus and stops when the IO needle is inserted.

Time frame: within 10 minutes of the procedure

Data from ClinicalTrials.gov

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