Back to resultsEZIO Compared to Central Venous Lines for Emergency Vascular Access
Primary Purpose
Catheters, Indwelling, Central Venous Line, Intraosseous Needle
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Powered Intraosseous device (EZIO)
standard central line
Sponsored by
About this trial
This is an interventional treatment trial for Catheters, Indwelling focused on measuring Catheters, Indwelling
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
Sites / Locations
- Dept of Emergency Medicine, The George Washington University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
EZIO
Central line
Outcomes
Primary Outcome Measures
Time taken to place the device
Secondary Outcome Measures
Incidence of complications
Costs for each of the two methods
Full Information
NCT ID
NCT00785252
First Posted
November 3, 2008
Last Updated
September 22, 2021
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
Vidacare Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00785252
Brief Title
EZIO Compared to Central Venous Lines for Emergency Vascular Access
Official Title
Randomized Study of the EZIO Compared to Central Venous Lines Used for Emergency Vascular Access
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor termination
Study Start Date
September 2008 (undefined)
Primary Completion Date
September 2010 (Anticipated)
Study Completion Date
September 2010 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
Vidacare Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catheters, Indwelling, Central Venous Line, Intraosseous Needle
Keywords
Catheters, Indwelling
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
EZIO
Arm Title
2
Arm Type
Experimental
Arm Description
Central line
Intervention Type
Device
Intervention Name(s)
Powered Intraosseous device (EZIO)
Intervention Description
EZIO
Intervention Type
Device
Intervention Name(s)
standard central line
Intervention Description
placement of a central line
Primary Outcome Measure Information:
Title
Time taken to place the device
Time Frame
ED visit
Secondary Outcome Measure Information:
Title
Incidence of complications
Time Frame
ED visit
Title
Costs for each of the two methods
Time Frame
Ed visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremty Brown, MD
Organizational Affiliation
George Washington University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeremy Brown
Organizational Affiliation
Dept of Emergency Medicine, GWU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept of Emergency Medicine, The George Washington University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.vidacare.com/
Description
Related Info
Learn more about this trial
EZIO Compared to Central Venous Lines for Emergency Vascular Access
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