Follow-Up Study Validating a Blended Technique

Vidacare Corporation10 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

Masking

NONE

Enrollment

Conditions

Intraosseous Vascular Access

Interventions

Proximal Humerus Intraosseous Vascular AccessPROCEDURE

Using the blended technique, device operators will establish proximal humerus intraosseous vascular access by inserting an IO needle.

EZ-IODEVICE

Eligibility

Sex: ALLMin age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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: * Previous training on establishing proximal humerus intraosseous vascular access

Locations (1)

Bulverde-Spring Branch EMS

Spring Branch, Texas, United States

Outcomes

Primary Outcomes

Successful IO insertion

Successful IO needle insertion determined by x-ray images

Time frame: Day 1 after establishing proximal humerus IO vascular access

Secondary Outcomes

Intraosseous Infusion flow rates

Intraosseous infusion flow rates attained using 4 different infusion pressures 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, using visualization of contrast injection under fluoroscopy.

Time frame: Day 1 after IO insertion

Relationship between IO and peripheral venous blood

IO blood and peripheral venous blood will be collected and analyzed for routine blood tests and the results will be compared to determine if there is a relationship.

Time frame: Day 1 after establishing IO vascular access and peripheral venous access

Data from ClinicalTrials.gov

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