Infusion Flow Rates and Blood Sampling

NCT02021617 | Unknown

• 1 other identifier: 2013-14
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intraosseous Access; Infusion Rates; Intraosseous Blood; Venous Blood

Keywords

Intraosseous Access; EZ-IO

Outcome Measures

Primary Outcomes (1)

• Infusion Flow Rates

  To evaluate infusion flow rates attainable when using the proximal humerus and proximal tibia IO vascular access. Intraosseous

  1 Day

Secondary Outcomes (2)

• IO blood versus venous blood

  1 Day

• IO needle insertion to IO access

  1 Day

Study Arms (1)

Intraosseous Access

NO INTERVENTION

This study will evaluate the proximal humerus and proximal tibia IO infusion sites for infusion flow rates attainable at specified infusion pressures. We will evaluate the IO infusion pathway to determine the mean time from IO contrast injection at the proximal humerus and proximal tibia sites to delivery to central circulation. This study will provide additional data regarding the relationship between IO and IV blood when used for routine laboratory analysis, adding to the current sample size. Lastly, this study will provide data to determine the average time from IO needle insertion to access of the IO space for immediate drug administration, and the average time from IO needle insertion to the ability to infuse fluids in the conscious subject. Intraosseous access.

Device: Intraosseous access

Interventions

Intraosseous access DEVICE

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.

Also known as: EZ-IO

Intraosseous Access

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Vidacare Corporation: lead

Study Sites (1)

Bulverde Spring Branch EMS

Spring Branch, Texas, 78070, United States

Location

Study Officials

• Larry J. Miller, MD

  Vidacare Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2013
• First Posted: December 27, 2013
• Study Start: November 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 27, 2013

Record last verified: 2013-12

Locations

US (1)