ivWatch in Prevention of Extravasation of Vesicants in an Oncology Setting
Purpose
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.
Conditions
- Oncology
- Extravasation
Eligibility
- Eligible Ages
- Between 18 Years and 95 Years
- Eligible Sex
- All
- Accepts 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Prevention
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Medical Device Usage |
Patients utilize ivWatch device at time of already scheduled chemotherapy on study |
|
Recruiting Locations
Buffalo 5110629, New York 5128638 14263
More Details
- Status
- Recruiting
- Sponsor
- Roswell Park Cancer Institute
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.