Vitls Feasibility Physiologic Monitoring

Completed

• Conditions: Vital Signs; Pediatrics; Remote Monitoring

• Registration Number: NCT05245747
• Lead Sponsor: Children's Mercy Hospital Kansas City

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.

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 Timeline

• Study First Submitted: 2022-01-19
• Study First Submitted QC: 2022-02-08
• Study First Posted: 2022-02-18
• Study Start: 2022-02-28
• Status Verified: 2023-05
• Primary Completion: 2023-05-16
• Study Completion: 2023-05-16
• Last Update Submitted: 2023-05-17
• Last Update Posted: 2023-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vital sign Heart Rate Feasibility	90 days	To evaluate the feasibility of collecting heart rate data with the Vitls Platform
Vital sign Oxygen saturation Feasibility	90 days	To evaluate the feasibility of collecting oxygen saturation data with the Vitls Platform
Vital sign Temperature Feasibility	90 days	To evaluate the feasibility of collecting temperature data with the Vitls Platform
Vital sign respiratory rate Feasibility	90 days	To evaluate the feasibility of collecting respiratory rate data with the Vitls Platform

Trial Locations

Locations (1)

Children's Mercy Kansas City; 🇺🇸 Kansas City, Missouri, United States