Optical Detection of Intravenous Infiltration:A Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Infiltration of Peripheral IV Therapy
• Intervention / Treatment: Device: ivWatch Model 400

• Study Type: Interventional
• Enrollment (Actual): 243
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Pilot; 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.	Device: ivWatch Model 400; The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses.
EXPERIMENTAL: Non-alarming; 150 patients will be enrolled in the non-alarming group. The ivWatch device will monitor the IV sites but will not issue infiltration notifications.	Device: ivWatch Model 400; The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses.
EXPERIMENTAL: Alarming; 150 patients will be enrolled in the alarming group. The IV sites will be monitored with the ivWatch Model 400 infiltration notifications enabled.	Device: ivWatch Model 400; The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time Infiltration Detected by Nurse	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.	Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week
Infiltration Sensitivity	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.	Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week
Notification Rate of ivWatch Device	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.	Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week

Collaborators and Investigators

• Sponsor: ivWatch, LLC

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (ACTUAL): July 1, 2016
• Study Completion (ACTUAL): July 1, 2016

Study Registration Dates

• First Submitted: September 16, 2015
• First Submitted That Met QC Criteria: September 16, 2015
• First Posted (ESTIMATE): September 17, 2015

Study Record Updates

• Last Update Posted (ACTUAL): April 6, 2017
• Last Update Submitted That Met QC Criteria: March 9, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: infiltration; extravasation; peripheral intravenous therapy
• Other Study ID Numbers: IVW-CLR-CS09-400