ivWatch in Prevention of Extravasation of Vesicants in an Oncology Setting

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

2395 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-17

Study Completion Date

2026-11-17

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Oncology Extravasation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Medical Device Usage

Patients utilize ivWatch device at time of already scheduled chemotherapy on study

Group Type EXPERIMENTAL

ivWatch

Intervention Type DEVICE

Patients wear ivWatch device at time of already scheduled chemotherapy on study.

Interventions

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ivWatch

Patients wear ivWatch device at time of already scheduled chemotherapy on study.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No