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

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.

Study Overview

• Status: Completed
• Conditions: Difficult Peripheral IV Access
• Intervention / Treatment: Procedure: IO access using EZ-IO®

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • York, Pennsylvania, United States, 17405
      • York Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: EZ-IO®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to Successful Placement of a Functioning USGIV/IO	at time of vascular access
Number of Successful Placements	at time of vascular access

Collaborators and Investigators

• Sponsor: WellSpan Health
• Collaborators: University of Pennsylvania
• Investigators: Principal Investigator: Erik Kochert, MD, York Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: August 28, 2012
• First Submitted That Met QC Criteria: August 29, 2012
• First Posted (Estimate): August 30, 2012

Study Record Updates

• Last Update Posted (Actual): March 23, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Intraosseous (IO) vascular access
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: 299341