Extravasation, Oncology
Conditions
Brief summary
This study aims to determine the feasibility of using the ivWatch (registered trademark) device to determine if there is an infiltration at the site of a peripheral intravenous (PIV) catheter. An infiltration is when the IV fluid leaks out of a vein and into the surrounding tissue. If medication starts leaking outside the vein, it can cause damage to the surrounding tissue. Using the ivWatch device may identify leaking fluid before the nurse is able to visually observe the signs or symptoms of the leaking fluid.
Detailed description
PRIMARY OBJECTIVE: I. Evaluate the feasibility of using the ivWatch device to detect extravasations of peripheral vesicants given in an adult oncology ambulatory population. SECONDARY OBJECTIVE: I. Evaluate the clinical outcomes of extravasations that occur with the use of the ivWatch device.
Interventions
DEVICEivWatch
Patients wear ivWatch device at time of already scheduled chemotherapy on study.
Sponsors
Roswell Park Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
* Patients requiring a peripheral IV for infusion of vesicant or vesicant-like agents (chemotherapy, other vesicant medications). * PIV must be inserted * Participant (or legal representative) must understand the nature of this study and verbally consent with the Research Study Information Sheet prior to receiving any study related procedure
Exclusion criteria
* Patients who are not getting a vesicant, irritant or vesicant like fluid infused. * Patients who are bruised, scarred, or tattooed in the area of the PIV. * Patients with skin integrity issues at the site of the PIV. * Patients who are on "light precautions." * Not for use in power injectors. * Not for use on mediports, implanted ports, IVAD, central lines, PICC lines. * Patients without a cancer diagnosis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection of extravasation in patients wearing ivWatch | Up to 1 year | Evaluated by the ratio of number ivWatch used for vesicant therapy over the total number of vesicant therapies for study participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in number of extravasations while wearing ivWatch | Up to 1 year | Summary of patient level data will be reported |
Countries
United States
Outcome results
None listed