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Infusion Flow Rates and Blood Sampling

NCT02021617 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2013-12-27

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Vidacare Corporation

    lead INDUSTRY

Principal Investigators

  • Larry J. Miller, MD · Vidacare Corporation

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2013-11-30
Completion
2013-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02021617 on ClinicalTrials.gov