Continuous Intraosseous Vascular Access Over 48 Hours

NCT01866475 | Completed Results

• 1 other identifier: 2011-16
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intraosseous Vascular Access

Keywords

IO access; Intraosseous vascular access; EZ-IO

Outcome Measures

Primary Outcomes (1)

• Serious Complications From Intraosseous (IO) Access

  Presence of serious complications from 48 hour intraosseous (IO) vascular access using EZ-IO.

  48 hours

Study Arms (4)

Renal Disease

ACTIVE COMPARATOR

Those with mild to moderate renal disease and had an EZ-IO for 48 hours

Device: EZ-IO

Diabetes

ACTIVE COMPARATOR

Those with controlled diabetes and had an EZ-IO for 48 hours

Device: EZ-IO

Renal disease and diabetes

ACTIVE COMPARATOR

Those with both mild to moderate renal disease and controlled diabetes and had an EZ-IO for 48 hours

Device: EZ-IO

Healthy adults

ACTIVE COMPARATOR

Those who are healthy, defined as lacking co-morbidities that are a study exclusion, and had an EZ-IO for 48 hours

Device: EZ-IO

Interventions

EZ-IO DEVICE

To have an EZ-IO placed up to 48 hours

Diabetes; Healthy adults; Renal Disease; Renal disease and diabetes

Eligibility Criteria

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

You may qualify if:

• years or older
• Self Identifying as having poor vascular access
• Healthy or Having at least one of the following conditions:
• Controlled diabetes, as evidenced by a glycosylated hemoglobin A1c (HbA1c) value of less than or equal to 8% at the time of screening. or
• Renal disease, Stages 1 to 3, as evidenced by the presence of albuminuria at the time of screening. Subjects albumin-creatinine ratio (ACR) must fall within the microalbuminuria or macroalbuminuria values: Microalbuminuria - ACR 17-250 mcg/mg for men; 25-355 mcg/mg for women or, Macroalbuminuria- ACR \>250 mcg/mg for men; \>355 mcg/mg for women

You may not qualify if:

• Imprisoned
• Self identifying as pregnant
• Cognitively impaired
• Fracture in target bone
• Excessive tissue and/or absence of adequated anatomical landmarks in target bone
• Signs and symptoms of infection in target area
• IO insertion in past 48 hours, prosthetic limb or joint or other significant orthopedic procedure in target bone
• Intravenous infusion within the past 30 days
• Current use of anti-coagulants
• Previous adverse reaction or known allergy to Lidocaine
• Current cardiac condition requiring pacemaker
• Currently taking beta blockers or calcium channel blockers for heart arrhythmia (use of beta blockers or calcium channel blocker for hypertension is allowed when indication of hypertension can be confirmed by physician
• Previous surgery for peripheral arterial disease
• History of ulcers to the extremities
• History of bilateral lymph node dissection in the arms or legs

Sponsors & Collaborators

• Vidacare Corporation: lead

Study Sites (1)

ICON Early Phase Services

San Antonio, Texas, 78209, United States

Location

Results Point of Contact

• Title: Tatiana Puga
• Organization: Teleflex

tatiana.puga@teleflex.com

2104451794

Study Officials

• Emanuel DeNoia, MD

  ICON Early Phase Services

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2013
• First Posted: May 31, 2013
• Study Start: November 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: April 9, 2024
• Results First Posted: April 9, 2024

Record last verified: 2024-03

Locations

US (1)