Vitls Feasibility Physiologic Monitoring

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.

Study Overview

• Status: Completed
• Conditions: Pediatrics; Vital Signs; Remote Monitoring
• Intervention / Treatment: Device: Vitls Tego Device

Detailed Description

After disbursement of information sheet has occurred and verbal parental consent has been obtained, the research staff will determine the initial date of implementation of the Vitls Platform based on need and clinical status. Outcomes will include initiation (first date/time used), persistence (frequency of Tégo and Vitls platform use between first date of use and last date of use and any issues with transfer of data), and feasibility (actual fit with physiologic heart rate, respiratory rate, temperature, and oxygen saturation) compared with standard monitoring data.

After the Tégo sensor has been worn, an electronic REDCap survey for feedback from the parent-child dyad via email or via mobile phone (whichever is the preferred method at enrollment). The researchers will obtain the preferred method of documentation/contact at time of enrollment by the parent entering that into the REDCap. If the child-parent dyad is discharged and a study team member is not available, a link will be sent by the preferred method.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Kansas City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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).

Description

Inclusion Criteria:

• • 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.

Exclusion Criteria:

• • 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Children's Mercy Hospital Kansas City
• Collaborators: American College of Cardiology; Vitls Inc.
• Investigators: Principal Investigator: Lori Erickson, PhD, Children's Mercy Hospital Kansas City

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Vitls Website

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2022
• Primary Completion (Actual): May 16, 2023
• Study Completion (Actual): May 16, 2023

Study Registration Dates

• First Submitted: January 19, 2022
• First Submitted That Met QC Criteria: February 8, 2022
• First Posted (Actual): February 18, 2022

Study Record Updates

• Last Update Posted (Actual): May 18, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: pediatric; physiologic vital signs
• Other Study ID Numbers: Study00001853

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No