Optical Detection of Intravenous Infiltration:A Pilot Study

Not Applicable

Completed

• Conditions: Infiltration of Peripheral IV Therapy
• Interventions: Device: ivWatch Model 400

• Registration Number: NCT02553421
• Lead Sponsor: ivWatch, LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-09-16
• Study First Submitted QC: 2015-09-16
• Study First Posted: 2015-09-17
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Results First Submitted: 2016-11-04
• Results First Submitted QC: 2016-11-04
• Results First Posted: 2017-01-05
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-09
• Last Update Posted: 2017-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 243

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pilot	ivWatch Model 400	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.
Non-alarming	ivWatch Model 400	150 patients will be enrolled in the non-alarming group. The ivWatch device will monitor the IV sites but will not issue infiltration notifications.
Alarming	ivWatch Model 400	150 patients will be enrolled in the alarming group. The IV sites will be monitored with the ivWatch Model 400 infiltration notifications enabled.

Primary Outcome Measures

Name	Time	Method
Time Infiltration Detected by Nurse	Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week	The difference in time to detection between the clinician and the ivWatch device is measured from the non-alarming group. This measurement reveals how much earlier the infiltration could have been detected by the ivWatch device compared to the clinician assessments. This metric is measured using the patients in the non-alarming group since an infiltration notification by the ivWatch device could bias the clinician's diagnosis.
Infiltration Sensitivity	Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week	The infiltration sensitivity is defined as the percentage of the clinician-confirmed infiltrations that are detected by the ivWatch device before the clinician's diagnosis. This metric is measured and reported separately for non-alarming and alarming groups, since an infiltration notification by the ivWatch device could bias the clinician's diagnosis.
Notification Rate of ivWatch Device	Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week	The notification rate is defined as the number of ivWatch device infiltration notifications issued in a certain amount of time, typically reported in units of notifications per day. The notification rate is the number of notifications per day, excluding cases with clinician confirmed infiltrations. This metric is measured using the subjects in the alarming group since the number of notifications could potentially depend on how quickly nurses reset the device.

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States