Intraosseous Access in the Emergency Department for Patients With Failed Attempts at Intravenous Access: A Randomized Trial Examining Resource Utilization and Patient Satisfaction

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by WellSpan Health
Sponsor:
Information provided by (Responsible Party):
WellSpan Health
ClinicalTrials.gov Identifier:
NCT01676350
First received: August 28, 2012
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

By doing this study, the investigators hope to learn whether patients with difficult to obtain IV access who are treated with IO access are more satisfied with their care and have better outcomes. The investigators are specifically studying the time difference between groups and the difference in the number of attempts required to obtain vascular access and begin to treat with fluids and medications. The study will also measure patient satisfaction and procedural pain, the frequency of central line placement, the length of stay in the hospital and emergency department, and adverse events to intravascular access to determine whether IO access can improve these measures.

The investigators hypothesize that the use of a protocol utilizing an IO device for select patients with failed IV access will reduce the time requirements to obtain vascular access, reduce the number of attempts needed to obtain IV access, reduce the ED LOS, and have no negative impact on patient satisfaction compared to the current ED practices.


Condition Intervention
Difficult Peripheral IV Access
Procedure: IO access using EZ-IO®

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intraosseous Access in the Emergency Department for Patients With Failed Attempts at Intravenous Access: A Randomized Trial Examining Resource Utilization and Patient Satisfaction

Further study details as provided by WellSpan Health:

Primary Outcome Measures:
  • Time to obtain vascular access [ Time Frame: at time of vascular access ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: December 2014
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard of care
If you are assigned to this group, you will be treated with whatever procedures your doctor feels are most appropriate to obtain vascular access. This may include additional attempts at an IV in your arms or legs with or without the use of an ultrasound, or your doctor may decide to attempt to place an IV in your neck or groin.
Experimental: 'IO access using EZ-IO®
If you are assigned to this group, you will receive an IO line at the location deemed most appropriate by your doctor. IO lines are placed in the shoulder, the shin below the knee, or, less commonly, in the ankle bone. IO lines are placed using an FDA-approved device called an EZ-IO®.
Procedure: IO access using EZ-IO®
IO line placed using an FDA-approved device called an EZ-IO®.
Other Name: EZ-IO®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 years of age or older
  2. Presenting to the York Hospital ED in need of IV access
  3. Patient will have no IV access despite 2 separate attempts at peripheral IV access by 2 different nurses.
  4. In addition, the IV team will have been consulted to place an IV and been unsuccessful.

Exclusion Criteria:

  1. Patients requiring immediate IV access for whom waiting until the IV team arrives is unacceptable
  2. Patients requiring central line for one of the following reasons:

    • Hemodynamic monitoring
    • Frequent blood draws
    • Administration of parenteral nutrition or vasoactive medications
    • Transvenous pacing or hemodialysis
    • Multiple lumen availability for administration of incompatible medications
  3. Patients not suitable for IO access based on one of the following reasons:

    • Fractures at preferred IO sites
    • Previous orthopedic procedures (prosthetic limb or joint) near preferred IO sites
    • IO needle in the preferred IO sites in previous 48 hours
    • Infection at the preferred IO sites
    • Inability to locate landmarks for placement at the preferred sites due to excessive tissue
  4. Inability to provide informed research consent (intoxicated, altered mental status, non-English speaking)
  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: NCT01676350

Contacts
Contact: Erik Kochert, MD 717-851-2450 ekochert@wellspan.org

Locations
United States, Pennsylvania
York Hospital Not yet recruiting
York, Pennsylvania, United States, 17405
Principal Investigator: Erik Kochert, MD         
Sponsors and Collaborators
WellSpan Health
Investigators
Principal Investigator: Erik Kochert, MD York Hospital
  More Information

No publications provided

Responsible Party: WellSpan Health
ClinicalTrials.gov Identifier: NCT01676350     History of Changes
Other Study ID Numbers: 299341
Study First Received: August 28, 2012
Last Updated: December 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by WellSpan Health:
Intraosseous (IO) vascular access

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 01, 2014