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EZIO Compared to Central Venous Lines for Emergency Vascular Access

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2011 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00785252
First Posted: November 5, 2008
Last Update Posted: February 7, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  Purpose
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.

Condition Intervention Phase
Catheters, Indwelling Central Venous Line Intraosseous Needle Device: Powered Intraosseous device (EZIO) Device: standard central line Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Study of the EZIO Compared to Central Venous Lines Used for Emergency Vascular Access

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Time taken to place the device [ Time Frame: ED visit ]

Secondary Outcome Measures:
  • Incidence of complications [ Time Frame: ED visit ]
  • Costs for each of the two methods [ Time Frame: Ed visit ]

Estimated Enrollment: 50
Study Start Date: September 2008
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
EZIO
Device: Powered Intraosseous device (EZIO)
EZIO
Experimental: 2
Central line
Device: standard central line
placement of a central line

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00785252


Contacts
Contact: Thomas Philbeck, PhD 210-587-3989

Locations
United States, District of Columbia
Dept of Emergency Medicine, The George Washington University Medical Center Recruiting
Washington, District of Columbia, United States, 20037
Sponsors and Collaborators
Vidacare Corporation
Investigators
Principal Investigator: Jeremty Brown, MD George Washington University
Principal Investigator: Jeremy Brown Dept of Emergency Medicine, GWU
  More Information

Additional Information:
Responsible Party: Thomas E. Philbeck, PhD, MBA, Vidacare Corporation
ClinicalTrials.gov Identifier: NCT00785252     History of Changes
Other Study ID Numbers: 100731 (completed)
First Submitted: November 3, 2008
First Posted: November 5, 2008
Last Update Posted: February 7, 2011
Last Verified: February 2011

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Catheters, Indwelling

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes