Observation of Intraosseous Vascular Access in the Emergency Department

Completed

• Conditions: Patients Requiring Urgent Vascular Access
• Interventions: Device: EZ-IO

• Registration Number: NCT01235078
• Lead Sponsor: Vidacare Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-11-03
• Study First Submitted QC: 2010-11-04
• Study First Posted: 2010-11-05
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-28
• Last Update Posted: 2012-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intraosseous vascular access	EZ-IO	subjects with urgent vascular access needs in whom intraosseous vascular access has been attempted and/or established.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Incidence of complications with intraosseous device	time subject has intraosseous vascular access, an average of 24 hours	Reported complications by intraosseous device operators.

Trial Locations

Locations (6)

Gulf Breeze Hospital; 🇺🇸 Gulf Breeze, Florida, United States

Omaha Children's Hospital and Medical Center; 🇺🇸 Omaha, Nebraska, United States

Advocate Lutheran General Hospital; 🇺🇸 Park Ridge, Illinois, United States

Baptist Hospital Pensacola; 🇺🇸 Pensacola, Florida, United States

Texas Tech University Medical Center; 🇺🇸 El Paso, Texas, United States

Methodist Healthcare, University Hospital; 🇺🇸 Memphis, Tennessee, United States