Infusion Flow Rates and Blood Sampling

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02021617
• Other study ID #: 2013-14
• Status: Enrolling by invitation
• Phase: N/A
• First received: October 24, 2013
• Last updated: December 19, 2013
• Start date: November 2013
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: Vidacare Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: December 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Age 21 years or older; Have no amputation of the upper or lower extremities; Able to lay flat on a table for up to 2 hours; Self-reported as healthy; Negative urine pregnancy test day of in-house study procedures (female subjects)

Exclusion Criteria:

• Have a known active infection in the body; Imprisoned; Pregnant ; Cognitively impaired ; Fracture in humerus or tibia, or significant trauma to the site; Excessive tissue and/or absence of adequate anatomical landmarks at proximal humerus and proximal tibia IO insertion sites; Infection in target area; Humeral/tibial IO insertion in past 48 hours, prosthetic limb or joint or other significant orthopedic procedure in humerus or tibia; Current use of anti-coagulants; Current cardiac condition requiring pacemaker or anti-arrhythmic drugs; Prior adverse reaction to lidocaine; History of impaired renal function; Prior adverse reaction to contrast media; Allergy to iodine containing medications; Allergy to shellfish; Have taken analgesics/anesthetics the day of in-house study procedures; Volunteers with any of the following characteristics may be excluded from the study at the discretion of the PI; Allergy to any food or drug; History of impaired hepatic function; History of cardiac disease; History of pheochromocytoma

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Bulverde Spring Branch EMS	Spring Branch	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Vidacare Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infusion Flow Rates	To evaluate infusion flow rates attainable when using the proximal humerus and proximal tibia IO vascular access. Intraosseous	1 Day	No
Secondary	IO blood versus venous blood	To evaluate that IO blood is equal to venous blood when used for laboratory testing when IO blood is the only option in an emergency situation. Intraosseous	1 Day	No
Secondary	IO needle insertion to IO access	To determine the time from IO needle insertion to IO access established. Intraosseous	1 Day	No