Ultrasound Detection of Peripheral IV Infiltration

NCT ID: NCT01800552

Last Updated: 2013-02-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2013-02-28

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.

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.

Conditions

Infiltration; IV Infiltration

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Interventions

Intentional infiltration of a peripheral IV site

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ivWatch, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Garret T Bonnema, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

ivWatch, LLC

Locations

ivWatch,LLC

Williamsburg, Virginia, United States

Countries

United States

Other Identifiers

IVWUS-001

Identifier Type: -

Identifier Source: org_study_id