Follow-Up Study Validating a Blended Technique to Identify the Proximal Humerus Intraosseous Vascular Access Site

Vidacare Corporation15 enrolled

Overview

A Follow-up Study Validating a Blended Technique for Identifying the Proximal Humerus Intraosseous Vascular Access Insertion Site

In 2012, the investigators from Vidacare evaluated 4 techniques commonly used to identify the proximal humerus IO insertion site to determine if one technique resulted in more consistent successful placement of the IO needle set with a higher level of confidence among device operators performing the techniques. Results suggest that a combination of the best features of the 4 techniques may lead to optimal IO needle set placement more consistently. This study is needed to validate the "Blended" proximal humerus IO insertion technique to confirm that use of the technique results in proper site identification among device operators and results in increased confidence.To most closely evaluate the Blended proximal humerus insertion technique and how it is received by clinicians who perform these procedures in actual patients, device operators will include licensed/certified clinicians including, emergency medicine technicians/paramedics and nurses.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Intraosseous Vascular Access Vascular Access

Interventions

Intraosseous Vascular AccessDEVICE

Intraossesous Vascular Access in the proximal humerus

Eligibility

Sex: ALLMin age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria Device Operators: * Currently licensed/certified Emergency Medicine Technicians, paramedic, or nurse * Have had no formal training on use of the proximal humerus IO insertion site * Demonstrate proper use of the device and technique during training portion and obtain approval from the device trainer to participate Exclusion Criteria for Device Operators: None Inclusion Criteria Healthy Subjects: * Age 21 years or older * Have no amputation of the upper extremities * Able to lay flat on a table for up to 2 hours * Self-reported as healthy, as confirmed by the PI Exclusion Criteria Health Subjects: * 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 IO insertion in past 48 hours, prosthetic limb or joint or other significant orthopedic procedure in humerus * Current use of anti-coagulants * Current cardiac condition requiring pacemaker or anti-arrhythmic drugs * Prior adverse reaction to lidocaine * Volunteers with any of the following characteristics may be excluded from the infusion pathway evaluation involving administration of contrast dye at the discretion of the PI: * Prior adverse reaction to contrast dye * Allergy to any food or drug * History of impaired renal function * History of impaired hepatic function * History of cardiac disease * History of pheochromocytoma

Locations (1)

Bulverde-Spring Branch EMS

Spring Branch, Texas, United States

Outcomes

Primary Outcomes

Proximal Humerus Intraosseous (IO) Insertion Site Placement Total Score

X-ray images of the inserted IO needle will be used to evaluate placement success and scored. Each insertion is scored by a musculoskeletal radiologist for two measures: Insertion Site Accuracy (scale range 0 - 3) and Needle Tip Location (scale range -7 to 7) as described below. The Total score is the sum of Insertion Site Accuracy Score and Needle Tip Location Score. Scale range -7 to 10; higher score indicates greater accuracy. Insertion Site Accuracy Score Scale is 0 to 3 where higher scores indicate greater accuracy: 3=center of greater tubercle, 2=perimeter of greater tubercle, 1=junction of greater tubercle and shaft or head, and 0=outside the greater tubercle. Needle tip Location Score Scale ranges from -7 to 7 where higher scores indicate more favorable needle tip location: 7=within center of proximal humerus (PH), 5=within PH not centered, 3= Near miss of PH, -3=In humeral head, -3=on epiphyseal line, -5=lateral miss (of the humerus), -7=medial miss (of the humerus).

Time frame: Day 1 Within 10 minutes following procedure

Time to Intraosseous 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: 1 day, within 10 minutes of procedure

Level of Confidence Score Pre-intraosseous Insertion

Device operators scored their perceived Level of Confidence with their assigned Intraosseous (IO) Insertion method. The score was reported following the completion of training but before performing the unilateral IO insertion. The Level of Confidence scale scores range from 1 to 5, where. 1=not at all confident, 2=slightly confident, 3=moderately confident, 4=very confident, and 5=extremely confident. Higher scores indicate greater level of confidence.

Time frame: Day 1 within 10 minutes of completing training

Level of Confidence Score Post-intraosseous Insertion

Data from ClinicalTrials.gov

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Secondary Outcomes

Intraosseous Infusion Flow Rates

Intraosseous infusion flow rates attained at tested infusion pressures, which may include Gravity; 100 mmHg, 200 mmHg and 300 mmHg.

Time frame: Day 1 after establishing IO vascular access

Time in Seconds for Fluid Delivery From the Proximal Humerus to the Heart

Time in seconds for fluid delivery from the proximal humerus to the heart, using visualization of contrast injection under fluoroscopy was performed and measured once for the participants in the Healthy Subjects: Blended Technique arm.

Time frame: Day 1 after IO insertion

Success Rate of Obtaining Laboratory Results for Both Intraosseous and Peripheral Venous Specimens

Number of Participants with Laboratory Results Successfully Obtained from both intraosseous (IO) and peripheral venous blood specimens. Success was determined if the point-of-care laboratory analysis system provided laboratory results values for both IO and Peripheral Venous specimens. It was deemed unsuccessful if the point-of-care system provided no laboratory results values and/or noted an error for at least one specimen. An intraosseous blood specimen and a peripheral venous blood specimen were collected from each subject

Time frame: Day 1 within 30 minutes after establishing proximal humerus IO vascular access and peripheral venous access