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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|ClinicalTrials.gov Identifier: NCT01676350|
Recruitment Status : Unknown
Verified June 2015 by WellSpan Health.
Recruitment status was: Recruiting
First Posted : August 30, 2012
Last Update Posted : June 8, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Difficult Peripheral IV Access||Procedure: IO access using EZ-IO®||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||280 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||August 2014|
|Estimated Primary Completion Date :||January 2016|
|Estimated Study Completion Date :||January 2016|
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 Name: EZ-IO®
- successful placement of a functioning USGIV/IO [ Time Frame: at time of vascular access ]
- time to successful access [ Time Frame: at time of vascular access ]
- number of attempts to successful access [ Time Frame: at time of vascular access ]
- time to therapy including but not limited to time to fluids, antibiotics, and antiarrythmics [ Time Frame: at time of vascular access ]
- access longevity [ Time Frame: at discharge ]
- complication rates [ Time Frame: at discharge ]
- patient satisfaction and pain scores [ Time Frame: within 48hrs from discharge ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01676350
|Contact: Erik Kochert, MDfirstname.lastname@example.org|
|United States, Pennsylvania|
|Hospital of the University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Nova Panebianco, MD, MPH 215-349-8506 Nova.Panebianco@uphs.upenn.edu|
|Principal Investigator: Nova Panebianco, MD, MPH|
|York, Pennsylvania, United States, 17405|
|Principal Investigator: Erik Kochert, MD|
|Principal Investigator:||Erik Kochert, MD||York Hospital|