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

Not Applicable

Completed

• Conditions: Difficult Peripheral IV Access
• Interventions: Procedure: IO access using EZ-IO®

• Registration Number: NCT01676350
• Lead Sponsor: WellSpan Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-28
• Study First Submitted QC: 2012-08-29
• Study First Posted: 2012-08-30
• Study Start: 2014-08
• Primary Completion: 2015-05
• Study Completion: 2015-06
• Results First Submitted: 2017-10-31
• Results First Submitted QC: 2022-01-03
• Status Verified: 2022-03
• Results First Posted: 2022-03-08
• Last Update Submitted: 2022-03-21
• Last Update Posted: 2022-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IO access using EZ-IO®	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®.

Primary Outcome Measures

Name	Time	Method
Time to Successful Placement of a Functioning USGIV/IO	at time of vascular access
Number of Successful Placements	at time of vascular access

Trial Locations

Locations (2)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

York Hospital; 🇺🇸 York, Pennsylvania, United States