Ultrasound Detection of Peripheral IV Infiltration

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

Study Overview

• Status: Completed
• Conditions: Infiltration; IV Infiltration
• Intervention / Treatment: Procedure: Intentional infiltration of a peripheral IV site

Detailed Description

Peripheral intravenous (PIV) therapy is one of the most common invasive procedures performed in US hospitals. A majority of hospital patients require intravenous therapy each year in the United States. Despite widespread use, a number of potential complications can occur during PIV therapy. One of the most common causes of IV complications is IV infiltration or extravasation. Infiltration is the leakage of non-vesicant fluids like saline into the surrounding tissue. Extravasation is the leakage of vesicant fluids, which include cytotoxic drugs, intravenous nutrition, and calcium, potassium, and bicarbonate solutions. If not detected and corrected early, infiltration and extravasation can lead to significant complications such as severe inflammation, compartment syndrome, and skin necrosis.

ivWatch, LLC has developed an investigational device that may detect IV infiltration and extravasation occurrences using a near infrared light sensor. Previous studies have evaluated the performance of the ivWatch device by comparing to a nurse's diagnosis. The nursing standard of care relies on tactile and visual indicators to diagnose an infiltration event. The ivWatch product often signals an infiltration event before these indicators are apparent to clinicians. Consequently, comparisons to the nurse's diagnosis often lead to questionable false positives for the ivWatch device. A better reference is required to evaluate the performance of the ivWatch device.

The purpose of this research study is to evaluate the ability of ultrasound to detect PIV infiltrations. Ultrasound is a depth-resolved imaging technique for evaluating tissue microstructure. Researchers have used ultrasound to examine exogenous fluids injected into cutaneous and subcutaneous tissue. Ultrasound has been used to detect small volumes of fluids such as cosmetic fillers and subcutaneous injections. These studies suggest ultrasound may be a potential reference standard for future evaluation of ivWatch devices.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Williamsburg, Virginia, United States, 23185
      • ivWatch,LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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
• received IV therapy in past 30 days
• history of seizures
• history of strokes
• sick or had infection in past 30 days
• high temperature (>99.6F)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: ivWatch, LLC
• Investigators: Principal Investigator: Garret T Bonnema, Ph.D., ivWatch, LLC

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: February 22, 2013
• First Submitted That Met QC Criteria: February 25, 2013
• First Posted (Estimate): February 27, 2013

Study Record Updates

• Last Update Posted (Estimate): February 27, 2013
• Last Update Submitted That Met QC Criteria: February 25, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Ultrasound Imaging; Extravasation; Infiltration; Leaking; PIV Infiltration; IV Infiltration; Ultrasound Detection of Infiltration
• Other Study ID Numbers: IVWUS-001