Ultrasound Detection of Peripheral IV Infiltration
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.
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.
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)