EZIO Compared to Central Venous Lines for Emergency Vascu... | NCT00785252

Studies
EZIO Compared to Central Venous Lines for Emergency Vascular Access

NCT00785252

Sponsor

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

Status

Withdrawn

Last Update Posted

Sep 28, 2021Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Catheters, Indwelling
Central Venous Line
Intraosseous Needle

Interventions

Powered Intraosseous device (EZIO)
standard central line

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor termination

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Sep 2010Estimated

Completion Date

Sep 2010Estimated

First Submitted Date

Nov 3, 2008

First Submission Date that Met QC Criteria

Nov 3, 2008

First Posted Date

Nov 5, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2021

Last Update Posted Date

Sep 28, 2021Actual

Name	Class
Vidacare Corporation	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	EZIO	Device: Powered Intraosseous device (EZIO)
2	Experimental	Central line	Device: standard central line

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Powered Intraosseous device (EZIO)	Device	EZIO	1
standard central line

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time taken to place the device		ED visit

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeremty Brown, MD	George Washington University	Principal Investigator
Jeremy Brown	Dept of Emergency Medicine, GWU	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept of Emergency Medicine, The George Washington University Medical Center		Washington D.C.	District of Columbia	20037	United States