NCT01866501

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 31, 2013

Completed
Last Updated

May 31, 2013

Status Verified

May 1, 2013

Enrollment Period

Same day

First QC Date

May 28, 2013

Last Update Submit

May 30, 2013

Conditions

Intraosseous Vascular Access

Keywords

Intraosseous Vascular AccessIO AccessIO Vascular AccessEZ-IO

Outcome Measures

Primary Outcomes (1)

  • Successful IO insertion

    Successful IO needle insertion determined by x-ray images

    Day 1 after establishing proximal humerus IO vascular access

Secondary Outcomes (3)

  • Intraosseous Infusion flow rates

    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.

    Day 1 after IO insertion

  • Relationship between IO and peripheral venous blood

    Day 1 after establishing IO vascular access and peripheral venous access

Study Arms (1)

Blended Technique

EXPERIMENTAL

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

Procedure: Proximal Humerus Intraosseous Vascular AccessDevice: EZ-IO

Interventions

Proximal Humerus Intraosseous Vascular AccessPROCEDURE

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

Also known as: EZ-IO, Intraosseous Vascular Access, Proximal Humerus IO Access, IO
Blended Technique
EZ-IODEVICE
Blended Technique

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Previous training on establishing proximal humerus intraosseous vascular access

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bulverde-Spring Branch EMS

Spring Branch, Texas, 78070, United States

Location

MeSH Terms

Interventions

Jupiter

Intervention Hierarchy (Ancestors)

PlanetsSolar SystemAstronomical ObjectsAstronomical PhenomenaPhysical Phenomena

Study Officials

  • Larry J Miller, MD

    Vidacare Corporation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2013

First Posted

May 31, 2013

Study Start

May 1, 2013

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

May 31, 2013

Record last verified: 2013-05

Locations

US(1)