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 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|
- Time to obtain vascular access [ Time Frame: at time of vascular access ] [ Designated as safety issue: No ]
|Study Start Date:||December 2014|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
No Intervention: Standard of care
If you are assigned to this group, you will be treated with whatever procedures your doctor feels are most appropriate to obtain vascular access. This may include additional attempts at an IV in your arms or legs with or without the use of an ultrasound, or your doctor may decide to attempt to place an IV in your neck or groin.
Experimental: 'IO access using EZ-IO®
If you are assigned to this group, you will receive an IO line at the location deemed most appropriate by your doctor. IO lines are placed in the shoulder, the shin below the knee, or, less commonly, in the ankle bone. 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®
Please refer to this study by its ClinicalTrials.gov identifier: NCT01676350
|Contact: Erik Kochert, MDfirstname.lastname@example.org|
|United States, Pennsylvania|
|York Hospital||Not yet recruiting|
|York, Pennsylvania, United States, 17405|
|Principal Investigator: Erik Kochert, MD|
|Principal Investigator:||Erik Kochert, MD||York Hospital|