Observation of Intraosseous Vascular Access in the Emergency Department

An Observational Study of Intraosseous Vascular Access Compared to Central Venous Catheters in the Emergency Department

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.

Study Overview

• Status: Completed
• Conditions: Patients Requiring Urgent Vascular Access
• Intervention / Treatment: Device: EZ-IO

• Study Type: Observational
• Enrollment (Actual): 105

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients requiring urgent vascular access

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 Names: EZ-IO by Vidacare, Powered intraosseous vascular access

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to vascular access	Time from opening intraosseous device packaging to initial infusion of drugs or fluids via the intraosseous route.	at time of patient's arrival to emergency department, average within 10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of complications with intraosseous device	Reported complications by intraosseous device operators.	time subject has intraosseous vascular access, an average of 24 hours

Collaborators and Investigators

• Sponsor: Vidacare Corporation

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: November 3, 2010
• First Submitted That Met QC Criteria: November 4, 2010
• First Posted (Estimate): November 5, 2010

Study Record Updates

• Last Update Posted (Estimate): July 2, 2012
• Last Update Submitted That Met QC Criteria: June 28, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: 2010-04 (AP HM)