NCT01866475

Continuous Intraosseous Vascular Access Over 48 Hours

A Study to Determine the Safety of Continuous Intraosseous Vascular Access Over a Period of 48 Hours

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: Vidacare Corporation · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

A prospective study to determine the safety of intraosseous (IO) access for a period up to 48 hours in healthy adult volunteers and volunteers with a history of mild to moderate renal disease and/or controlled diabetes.

Detailed description

A prospective, study to determine the safety of intraosseous (IO) access for a period up to 48 hours, in healthy adult volunteers and volunteers with a history of being health-compromised, including patients with mild to moderate renal disease (National Health and Nutrition Examination Survey Stage 1 to 3) and/or patients with controlled diabetes. Subjects will be randomized to receive IO access in the proximal tibia insertion site or the proximal humerus insertion site using the EZ-IO intraosseous vascular access system. The hypothesis is that there will be no serious complications for the subjects during a 48 hour IO catheter dwell time in either place.

Conditions

• Intraosseous Vascular Access

Interventions

Type	Name	Description
DEVICE	EZ-IO	To have an EZ-IO placed up to 48 hours

Timeline

• Start date: 2014-11-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2013-05-31
• Last updated: 2024-04-09
• Results posted: 2024-04-09

Locations

1 site across 1 country: United States