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

Primary Purpose

Difficult Peripheral IV Access

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IO access using EZ-IO®
Sponsored by
WellSpan Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Difficult Peripheral IV Access focused on measuring Intraosseous (IO) vascular access

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital of the University of Pennsylvania
  • York Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of care

IO access using EZ-IO®

Arm Description

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

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®.

Outcomes

Primary Outcome Measures

Time to Successful Placement of a Functioning USGIV/IO
Number of Successful Placements

Secondary Outcome Measures

Full Information

First Posted
August 28, 2012
Last Updated
March 21, 2022
Sponsor
WellSpan Health
Collaborators
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT01676350
Brief Title
Intraosseous Access in the Emergency Department for Patients With Failed Attempts at Intravenous Access: A Randomized Trial Examining Resource Utilization and Patient Satisfaction
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
August 2014 (Actual)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
WellSpan Health
Collaborators
University of Pennsylvania

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Difficult Peripheral IV Access
Keywords
Intraosseous (IO) vascular access

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
If you are assigned to this group, ultrasound-guided IV will be used to obtain vascular access.
Arm Title
IO access using EZ-IO®
Arm Type
Experimental
Arm Description
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®.
Intervention Type
Procedure
Intervention Name(s)
IO access using EZ-IO®
Other Intervention Name(s)
EZ-IO®
Intervention Description
IO line placed using an FDA-approved device called an EZ-IO®.
Primary Outcome Measure Information:
Title
Time to Successful Placement of a Functioning USGIV/IO
Time Frame
at time of vascular access
Title
Number of Successful Placements
Time Frame
at time of vascular access

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age or older Hemodynamically stable Speaks English Able to consent 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik Kochert, MD
Organizational Affiliation
York Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
York Hospital
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17405
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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