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

NCT01676350 | Completed Results

• 1 other identifier: 299341
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Difficult Peripheral IV Access

Keywords

Intraosseous (IO) vascular access

Outcome Measures

Primary Outcomes (2)

• Time to Successful Placement of a Functioning USGIV/IO

  at time of vascular access

• Number of Successful Placements

  at time of vascular access

Study Arms (2)

Standard of care

NO INTERVENTION

If you are assigned to this group, ultrasound-guided IV will be used to obtain vascular access.

IO access using EZ-IO®

EXPERIMENTAL

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®

Interventions

IO access using EZ-IO® PROCEDURE

IO line placed using an FDA-approved device called an EZ-IO®.

Also known as: EZ-IO®

IO access using EZ-IO®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Hemodynamically stable
• Speaks English
• Able to consent
• Has difficult IV access

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• WellSpan Health: lead
• University of Pennsylvania: collaborator

Study Sites (2)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

York Hospital

York, Pennsylvania, 17405, United States

Location

Results Point of Contact

• Title: Brent Becker
• Organization: WellSpan York Hospital

bbecker2@wellspan.org

717-851-2223

Study Officials

• Erik Kochert, MD

  York Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2012
• First Posted: August 30, 2012
• Study Start: August 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: June 1, 2015
• Last Updated: March 23, 2022
• Results First Posted: March 8, 2022

Record last verified: 2022-03

Locations

US (2)