ivWatch in Prevention of Extravasation of Vesicants in an Oncology Setting

Roswell Park Comprehensive Cancer Center

Status

Enrolling

Conditions

Oncology

Extravasation

Treatments

Device: ivWatch

Study type

Interventional

Funder types

Other

Identifiers

NCT06758011

I-2794222

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,395 estimated patients

Sex

All

Ages

18 to 95 years old

Volunteers

No Healthy Volunteers

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.