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Follow-Up Study Validating a Blended Technique

NCT ID: NCT01866501

Last Updated: 2013-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Intraosseous Vascular Access

Keywords

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Intraosseous Vascular Access IO Access IO Vascular Access EZ-IO

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Blended Technique

Using the blended technique device operators will establish proximal humerus intraosseous vascular access.

Group Type EXPERIMENTAL

Proximal Humerus Intraosseous Vascular Access

Intervention Type PROCEDURE

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

EZ-IO

Intervention Type DEVICE

Interventions

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Proximal Humerus Intraosseous Vascular Access

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

Intervention Type PROCEDURE

EZ-IO

Intervention Type DEVICE

Other Intervention Names

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EZ-IO Intraosseous Vascular Access Proximal Humerus IO Access IO

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vidacare Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Larry J Miller, MD

Role: PRINCIPAL_INVESTIGATOR

Vidacare Corporation

Locations

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Bulverde-Spring Branch EMS

Spring Branch, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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2013-06

Identifier Type: -

Identifier Source: org_study_id