NCT00785252

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

September 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 5, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

September 28, 2021

Status Verified

September 1, 2021

Enrollment Period

2 years

First QC Date

November 3, 2008

Last Update Submit

September 22, 2021

Conditions

Catheters, IndwellingCentral Venous LineIntraosseous Needle

Keywords

Catheters, Indwelling

Outcome Measures

Primary Outcomes (1)

  • Time taken to place the device

    ED visit

Secondary Outcomes (2)

  • Incidence of complications

    ED visit

  • Costs for each of the two methods

    Ed visit

Study Arms (2)

1

EXPERIMENTAL

EZIO

Device: Powered Intraosseous device (EZIO)

2

EXPERIMENTAL

Central line

Device: standard central line

Interventions

Powered Intraosseous device (EZIO)DEVICE

EZIO

1
standard central lineDEVICE

placement of a central line

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Emergency Medicine, The George Washington University Medical Center

Washington D.C., District of Columbia, 20037, United States

Location

Related Links

Study Officials

  • Jeremty Brown, MD

    George Washington University

    PRINCIPAL INVESTIGATOR

  • Jeremy Brown

    Dept of Emergency Medicine, GWU

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2008

First Posted

November 5, 2008

Study Start

September 1, 2008

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

September 28, 2021

Record last verified: 2021-09

Locations

US(1)