NCT02021617

Infusion Flow Rates and Blood Sampling

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Vidacare Corporation · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

* 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.

Detailed description

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.

Conditions

• Intraosseous Access
• Infusion Rates
• Intraosseous Blood
• Venous Blood

Interventions

Type	Name	Description
DEVICE	Intraosseous access	The EZ-IO Intraosseous Vascular Access System (Vidacare Corporation, Shavano Park, TX, USA) has been cleared by the U.S. Food and Drug Administration, Health Canada, and the European Union for the administration of drugs and fluids anytime vascular access is difficult to obtain in emergent, urgent, or medically necessary cases. It consists of a driver-a small battery-powered drill-and a needle set designed for insertion into the IO space of the proximal tibia, distal tibia, or proximal humerus. Needles are 15 gauge and available in three lengths: 15 mm, 25 mm, and 45 mm. In this study the 45 mm EZ-IO needle set will be used for all humeral placements and the 25 mm needle set will be used for all tibial placements.

Timeline

• Start date: 2013-11-01
• Primary completion: 2013-11-01
• Completion: 2013-12-01
• First posted: 2013-12-27
• Last updated: 2013-12-27

Locations

1 site across 1 country: United States