Observation of Intraosseous Vascular Access in the Emergency Department

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vidacare Corporation
ClinicalTrials.gov Identifier:
NCT01235078
First received: November 3, 2010
Last updated: June 28, 2012
Last verified: June 2012
  Purpose

The purpose of this study is to evaluate the use of powered intraosseous vascular access (EZ-IO by Vidacare) in the emergency department for patients requiring urgent vascular access. Data collected will be compared to historical data on central venous catheter use in the emergency department. The primary hypothesis is that powered intraosseous vascular access will decrease the amount of time needed to obtain vascular access.


Condition Intervention
Patients Requiring Urgent Vascular Access
Device: EZ-IO

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: An Observational Study of Intraosseous Vascular Access Compared to Central Venous Catheters in the Emergency Department

Further study details as provided by Vidacare Corporation:

Primary Outcome Measures:
  • Time to vascular access [ Time Frame: at time of patient's arrival to emergency department, average within 10 minutes ] [ Designated as safety issue: No ]
    Time from opening intraosseous device packaging to initial infusion of drugs or fluids via the intraosseous route.


Secondary Outcome Measures:
  • Incidence of complications with intraosseous device [ Time Frame: time subject has intraosseous vascular access, an average of 24 hours ] [ Designated as safety issue: No ]
    Reported complications by intraosseous device operators.


Enrollment: 105
Study Start Date: April 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Intraosseous vascular access
subjects with urgent vascular access needs in whom intraosseous vascular access has been attempted and/or established.
Device: EZ-IO
powered intraosseous vascular access system
Other Name: EZ-IO by Vidacare, Powered intraosseous vascular access

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients requiring urgent vascular access

Criteria

Inclusion Criteria:

  • Patients requiring vascular access who would otherwise receive a central venous catheter due to lack of other options.

Exclusion Criteria:

  • Fracture in target bone, or significant trauma to the site
  • Excessive tissue and/or absence of adequate anatomical landmarks in target bone
  • Infection in target area
  • IO insertion in past 24 hours, prosthetic limb or joint or other significant orthopedic procedure in target bone
  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: NCT01235078

Locations
United States, Florida
Gulf Breeze Hospital
Gulf Breeze, Florida, United States, 32561
Baptist Hospital Pensacola
Pensacola, Florida, United States, 32522
United States, Illinois
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States, 60068
United States, Nebraska
Omaha Children's Hospital and Medical Center
Omaha, Nebraska, United States, 68198
United States, Tennessee
Methodist Healthcare, University Hospital
Memphis, Tennessee, United States, 38104
United States, Texas
Texas Tech University Medical Center
El Paso, Texas, United States, 79905
Sponsors and Collaborators
Vidacare Corporation
  More Information

No publications provided

Responsible Party: Vidacare Corporation
ClinicalTrials.gov Identifier: NCT01235078     History of Changes
Other Study ID Numbers: 2010-04
Study First Received: November 3, 2010
Last Updated: June 28, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 16, 2014