EZIO Compared to Central Venous Lines for Emergency Vascular Access

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00785252
First received: November 3, 2008
Last updated: February 4, 2011
Last verified: February 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of complications [ Time Frame: ED visit ] [ Designated as safety issue: Yes ]
  • Costs for each of the two methods [ Time Frame: Ed visit ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Thomas E. Philbeck, PhD, MBA, Vidacare Corporation
ClinicalTrials.gov Identifier: NCT00785252     History of Changes
Other Study ID Numbers: 100731 (completed)
Study First Received: November 3, 2008
Last Updated: February 4, 2011
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 01, 2014