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 currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by WellSpan Health
Sponsor:
Collaborator:
University of Pennsylvania
Information provided by (Responsible Party):
WellSpan Health
ClinicalTrials.gov Identifier:
NCT01676350
First received: August 28, 2012
Last updated: September 24, 2014
Last verified: September 2014
  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:
  • successful placement of a functioning USGIV/IO [ Time Frame: at time of vascular access ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • time to successful access [ Time Frame: at time of vascular access ] [ Designated as safety issue: No ]
  • number of attempts to successful access [ Time Frame: at time of vascular access ] [ Designated as safety issue: No ]
  • time to therapy including but not limited to time to fluids, antibiotics, and antiarrythmics [ Time Frame: at time of vascular access ] [ Designated as safety issue: No ]
  • access longevity [ Time Frame: at discharge ] [ Designated as safety issue: No ]
  • complication rates [ Time Frame: at discharge ] [ Designated as safety issue: No ]
  • patient satisfaction and pain scores [ Time Frame: within 48hrs from discharge ] [ Designated as safety issue: No ]

Estimated Enrollment: 280
Study Start Date: August 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, ultrasound-guided IV will be used to obtain vascular access.
Experimental: 'IO access using EZ-IO®
If you are assigned to this group, you will receive an IO line in the humeral head of the shoulder. 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. Hemodynamically stable
  3. Speaks English
  4. Able to consent
  5. Has difficult IV access

Exclusion Criteria:

1. Patients who are younger than 18 years of age, b) lack English fluency c) are unable to give informed consent d) require immediate central venous access e) have a history of osteomyelitis in the only target location of IO access f) have a fracture in the bone of the only target IO site g) have received an IO in the last 24 hours of the only target site h) are allergic to lidocaine i) pregnant or j) require a contrast CT scan as part of their ED care will be excluded.

While pregnant patients may benefit from rescue access the use of lidocaine to anesthetize the medullary space has not been studied in this population.

  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
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Nova Panebianco, MD, MPH    215-349-8506    Nova.Panebianco@uphs.upenn.edu   
Principal Investigator: Nova Panebianco, MD, MPH         
York Hospital Not yet recruiting
York, Pennsylvania, United States, 17405
Principal Investigator: Erik Kochert, MD         
Sponsors and Collaborators
WellSpan Health
University of Pennsylvania
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: September 24, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 23, 2014