EZIO Compared to Central Venous Lines for Emergency Vascular Access

September 22, 2021 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Randomized Study of the EZIO Compared to Central Venous Lines Used for Emergency Vascular Access

Multicenter randomized study to compare powered intraosseous access to standard central line access for the administration of fluids and drugs for patients in the Emergency Dept.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • Dept of Emergency Medicine, The George Washington University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Over 18 years old Requires central access after peripheral access attempts have failed or are not otherwise feasible

Exclusion Criteria:

Fracture in target bone Not able to sign informed consent Excessive tissue or absence of adequate anatomical landmarks Known or suspected coagulopathies Pregnancy Patients in custody Patients with suspected great vessel injury Not fluid in English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
EZIO
Device: Powered Intraosseous device (EZIO)
EZIO
Experimental: 2
Central line
Device: standard central line
placement of a central line

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time taken to place the device
Time Frame: ED visit
ED visit

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of complications
Time Frame: ED visit
ED visit
Costs for each of the two methods
Time Frame: Ed visit
Ed visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborators

Vidacare Corporation

Investigators

  • Principal Investigator: Jeremty Brown, MD, George Washington University
  • Principal Investigator: Jeremy Brown, Dept of Emergency Medicine, GWU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Anticipated)

September 1, 2010

Study Completion (Anticipated)

September 1, 2010

Study Registration Dates

First Submitted

November 3, 2008

First Submitted That Met QC Criteria

November 3, 2008

First Posted (Estimate)

November 5, 2008

Study Record Updates

Last Update Posted (Actual)

September 28, 2021

Last Update Submitted That Met QC Criteria

September 22, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100731 (completed)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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