Ultrasound Detection of Peripheral IV Infiltration

NCT01800552 | Completed

• 1 other identifier: IVWUS-001
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether commercial ultrasound imaging systems can discern normal from infiltrated tissue near a peripheral intravenous site.

Conditions

Infiltration; IV Infiltration

Keywords

Infiltration; Extravasation; Leaking; PIV Infiltration; IV Infiltration; Ultrasound Detection of Infiltration; Ultrasound Imaging

Outcome Measures

Primary Outcomes (1)

• Test diagnostic performance of ultrasound imaging for detection of peripheral IV infiltration.

  Ultrasound images are acquired before and after the induced infiltration on the test arm. Two additional ultrasound images are acquired from the normal control arm. At the end of the study, the before and after images from the test and control arms are evaluated and classified by clinicians blinded to the state of the tissue. Sensitivity and specificity metrics are used to evaluate the performance of ultrasound imaging for assessing peripheral IV infiltration.

  Within 15 minutes of intentional PIV infiltration

Interventions

Intentional infiltration of a peripheral IV site PROCEDURE

An intentional infiltration of isotonic saline solution is performed by pushing the needle through the vein wall into the subcutaneous tissue. A total volume less than or equal to 5 cc of saline is infiltrated into the tissue.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy adult volunteers (18 years or older) that were friends, family members, or employees of ivWatch, LLC participated in this study.

You may qualify if:

• years or older
• signed consent
• health form approved by professional practitioner

You may not qualify if:

• abnormal bleeding or hemophilia
• absence of sensation in arms
• anemia
• cardiopulmonary disorders
• clotting disorders
• dehydration
• dizziness or fainting
• hepatitis
• high blood pressure (\>160 systolic or \> 115 diastolic)
• HIV / AIDS
• immune deficiency disorders
• known history of difficult venous access
• lymphedema
• major surgery or scar tissue which would complicate venous access
• recent radiation or chemotherapy

Sponsors & Collaborators

• ivWatch, LLC: lead

Study Sites (1)

ivWatch,LLC

Williamsburg, Virginia, 23185, United States

Location

Study Officials

• Garret T Bonnema, Ph.D.

  ivWatch, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2013
• First Posted: February 27, 2013
• Study Start: February 1, 2013
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: February 27, 2013

Record last verified: 2013-02

Locations

US (1)