Vitls Feasibility Physiologic Monitoring

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05245747
Study type	Observational
Source	Children's Mercy Hospital Kansas City
Contact
Status	Completed
Phase
Start date	February 28, 2022
Completion date	May 16, 2023

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