Ultrasound Detection of Peripheral IV Infiltration

Infiltration Clinical Trial

Official title:

Ultrasound Detection of Peripheral IV Infiltration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01800552
• Other study ID #: IVWUS-001
• Status: Completed
• Phase: N/A
• First received: February 22, 2013
• Last updated: February 25, 2013
• Start date: February 2013
• Est. completion date: February 2013

Study information

• Verified date: February 2013
• Source: ivWatch, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Infiltration
• IV Infiltration

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United States	ivWatch,LLC	Williamsburg	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
ivWatch, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes