Follow-Up Study Validating a Blended Technique

Not Applicable

Completed

• Conditions: Intraosseous Vascular Access
• Interventions: Procedure: Proximal Humerus Intraosseous Vascular Access; Device: EZ-IO

• Registration Number: NCT01866501
• Lead Sponsor: Vidacare Corporation

Brief Summary

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

Detailed Description

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 Timeline

• Status Verified: 2013-05
• Study Start: 2013-05
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Study First Submitted: 2013-05-28
• Study First Submitted QC: 2013-05-30
• Last Update Submitted: 2013-05-30
• Study First Posted: 2013-05-31
• Last Update Posted: 2013-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blended Technique	Proximal Humerus Intraosseous Vascular Access	Using the blended technique device operators will establish proximal humerus intraosseous vascular access.
Blended Technique	EZ-IO	Using the blended technique device operators will establish proximal humerus intraosseous vascular access.

Primary Outcome Measures

Name	Time	Method
Successful IO insertion	Day 1 after establishing proximal humerus IO vascular access	Successful IO needle insertion determined by x-ray images

Secondary Outcome Measures

Name	Time	Method
Intraosseous Infusion flow rates	Day 1 after establishing IO vascular access	Intraosseous infusion flow rates attained using 4 different infusion pressures Gravity; 100 mmHg, 200 mmHg and 300 mmHg.
Relationship between IO and peripheral venous blood	Day 1 after establishing IO vascular access and peripheral venous access	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 in seconds for fluid delivery from the proximal humerus to the heart, using visualization of contrast injection under fluoroscopy.	Day 1 after IO insertion

Trial Locations

Locations (1)

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