Optical Detection of Intravenous Infiltration:A Pilot Study

ivWatch

Status

Completed

Conditions

Infiltration of Peripheral IV Therapy

Treatments

Device: ivWatch Model 400

Study type

Interventional

Funder types

Industry

Identifiers

NCT02553421

IVW-CLR-CS09-400

Details and patient eligibility

About

This study will examine the use of the ivWatch Model 400 to monitor PIV sites in pediatric patients. Half the participants will be monitored by the device without infiltration notifications and the other half will be monitored by the device with infiltration notifications enabled.

Enrollment

243 patients

Sex

All

Ages

Under 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Signed consent and/or assent
Newborn to 17 years of age
Weight > 2.5 kg

Exclusion criteria

Severe skin integrity issues such as severe eczema, burns, epidermolysis bullosa, rash, hives
Severe scarring of tissue (excessive IV use)
Tattoo in area of PIV site
IV site located in antecubital fossa

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

243 participants in 3 patient groups

Pilot

Experimental group

Description:

A non-alarming ivWatch device will monitor the IV sites of these subjects. The goal of this small pilot study is to give clinicians an opportunity to perform the protocol and operate the ivWatch device and to give researchers the ability to make adjustments prior to starting the subsequent non-alarming group.

Treatment:

Device: ivWatch Model 400

Non-alarming

Experimental group

Description:

150 patients will be enrolled in the non-alarming group. The ivWatch device will monitor the IV sites but will not issue infiltration notifications.

Treatment:

Device: ivWatch Model 400

Alarming

Experimental group

Description:

150 patients will be enrolled in the alarming group. The IV sites will be monitored with the ivWatch Model 400 infiltration notifications enabled.