NCT02553421

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
243

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 17, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
6 months until next milestone

Results Posted

Study results publicly available

January 5, 2017

Completed
Last Updated

April 6, 2017

Status Verified

March 1, 2017

Enrollment Period

11 months

First QC Date

September 16, 2015

Results QC Date

November 4, 2016

Last Update Submit

March 9, 2017

Conditions

Infiltration of Peripheral IV Therapy

Keywords

infiltrationextravasationperipheral intravenous therapy

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (3)

Pilot

EXPERIMENTAL

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

Non-alarming

EXPERIMENTAL

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

Alarming

EXPERIMENTAL

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

Interventions

ivWatch Model 400DEVICE

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.

AlarmingNon-alarmingPilot

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Results Point of Contact

Title
Jason Naramore
Organization
ivWatch, LLC
jason.naramore@ivwatch.com
855-485-2824

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2015

First Posted

September 17, 2015

Study Start

August 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

April 6, 2017

Results First Posted

January 5, 2017

Record last verified: 2017-03

Locations

US(1)