Intraosseous Access Clinical Trial
Official title:
A Study Comparing Infusion Flow Rates Using the Proximal Humerus and Proximal Tibia Intraosseous Vascular Access Insertion Sites and Comparing Intraosseous and Venous Blood for Laboratory Specimen Sampling
- To evaluate infusion flow rates attainable when using the proximal humerus and proximal
tibia IO vascular access sites.
- To evaluate the intraosseous infusion physiology when using the proximal humerus and
proximal tibia IO infusion sites.
- To further evaluate the relationship between IO and venous blood when used for
laboratory testing.
- To determine the time from IO needle insertion to IO access established.
Often in emergencies and other medical situations, doctors must gain vascular access (access
to the blood stream) in order to give drugs and/or fluids to patients. The most common way
to gain vascular access is to place a needle into a vein through the skin, but sometimes
this is not possible. Another way to gain vascular access is to insert a needle through the
skin, into the bone and give drugs and/or fluids to patients through the center of the bone,
which is hollow and contains blood vessels. This is called intraosseous (IO) vascular
access. One device used to gain intraosseous vascular access is called the EZ-IO®
Intraosseous Vascular Access System and it can be used in the proximal humerus (upper arm
bone), proximal tibia (upper shin bone), and the distal tibia (lower shin bone). The EZ-IO
has been cleared by the FDA to establish IO vascular access in the sites identified above
for the infusion of drugs and fluids anytime vascular access is difficult to obtain in
emergent, urgent, or medically necessary cases.
IV fluids and medicines must be infused into a patient's blood stream at different speeds
depending upon what is being infused. Some IV fluids and medications must be given slowly
and some must be given quickly. How fast IV fluids and medicines are infused into the blood
stream is called infusion flow rate. One way to increase the infusion flow rate is to apply
pressure to (squeeze) the IV fluid bag being used. This is done by applying a pressure bag
around the IV fluid bag, which acts like a blood pressure cuff and inflates when pumped up.
The purpose of this study is to see how quickly IV fluids can be infused into your blood
stream through the proximal humerus (upper arm bone) and the proximal tibia (upper shin
bone) by measuring the infusion flow rate. We want to see how fast IV fluids can be infused
into your blood stream at different infusion pressures. We will also look at the route the
fluid travels from the IO needle in your arm and leg to the heart.
Another purpose of the study is to determine if blood drawn from the bone can be used for
laboratory tests the same as blood drawn from a vein or collected using a finger stick.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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