NCT05245747

Brief Summary

A single site, cross-sectional, feasibility study will be used to evaluate the feasibility of the collection of physiologic data related to the use of the Vitls Platform in the pediatric (\< 2 year of age) congenital heart and general surgery populations in the hospital setting that is using 24 hour a day monitoring for routine care over a 48-hour period. A short questionnaire will be sent electronically for the parent-child dyad feedback after the participating child has worn the device. No data will be available at the time of placement for the Healthcare team and will not replace any routine/standard of care monitoring already in place for this complex population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2022

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

First Submitted

Initial submission to the registry

January 19, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 18, 2022

Completed
10 days until next milestone

Study Start

First participant enrolled

February 28, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2023

Completed
Last Updated

May 18, 2023

Status Verified

May 1, 2023

Enrollment Period

1.2 years

First QC Date

January 19, 2022

Last Update Submit

May 17, 2023

Conditions

Vital SignsPediatricsRemote Monitoring

Keywords

pediatricphysiologic vital signs

Outcome Measures

Primary Outcomes (4)

  • Vital sign Heart Rate Feasibility

    To evaluate the feasibility of collecting heart rate data with the Vitls Platform

    90 days

  • Vital sign Oxygen saturation Feasibility

    To evaluate the feasibility of collecting oxygen saturation data with the Vitls Platform

    90 days

  • Vital sign Temperature Feasibility

    To evaluate the feasibility of collecting temperature data with the Vitls Platform

    90 days

  • Vital sign respiratory rate Feasibility

    To evaluate the feasibility of collecting respiratory rate data with the Vitls Platform

    90 days

Interventions

Vitls Tego DeviceDEVICE

The Tégo VSS Sensor is a battery-operated adhesive patch with integrated sensors and wireless transceiver which is worn on the upper body and records heart rate (HR), respiration rate, blood oxygen levels (SpO2), and body temperature. The Tégo VSS Sensor continuously gathers multiparameter physiological data from the person being monitored and then transmits the encrypted data via bi-directional communication to a third-party connectivity relay.

Also known as: Tego VSS Sensor

Eligibility Criteria

AgeUp to 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Maximum of 50 infants to be enrolled (with the hope to have evaluable data from 20 of these subjects - i.e. this will allow us to account for possible participant attrition, particularly in the beginning of the trial, and the enrollment of up to 25 patients will allow for the learning curve that will have to be overcome by the study team).

You may qualify if:

  • Study participants will be pediatric patients who have undergone cardiac surgery, interventional or diagnostic cardiac catheterizations or former preterm infants undergoing a general surgery procedure at Children's Mercy Kansas City and are currently less than 2 years of age at the time of being approached for participation in this study.
  • Parents of qualifying subjects will also be included in this study.

You may not qualify if:

  • Two years of age or older
  • Left sided thoracotomy incision
  • Removal for sternal wound with infection/erythema to site
  • Parents under the age of 18 at the time the study team would approach the family.
  • Infants less than 37 weeks gestation at birth or as determined appropriate by the study team.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Mercy Kansas City

Kansas City, Missouri, 64108, United States

Location

Related Publications (2)

  • Kumar N, Akangire G, Sullivan B, Fairchild K, Sampath V. Continuous vital sign analysis for predicting and preventing neonatal diseases in the twenty-first century: big data to the forefront. Pediatr Res. 2020 Jan;87(2):210-220. doi: 10.1038/s41390-019-0527-0. Epub 2019 Aug 4.

    PMID: 31377752BACKGROUND

  • Sasangohar F, Davis E, Kash BA, Shah SR. Remote Patient Monitoring and Telemedicine in Neonatal and Pediatric Settings: Scoping Literature Review. J Med Internet Res. 2018 Dec 20;20(12):e295. doi: 10.2196/jmir.9403.

    PMID: 30573451BACKGROUND

Related Links

Study Officials

  • Lori Erickson, PhD

    Children's Mercy Hospital Kansas City

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Remote Health Solutions

Study Record Dates

First Submitted

January 19, 2022

First Posted

February 18, 2022

Study Start

February 28, 2022

Primary Completion

May 16, 2023

Study Completion

May 16, 2023

Last Updated

May 18, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)