NCT05245747

Vitls Feasibility Physiologic Monitoring

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Children's Mercy Hospital Kansas City · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vital Signs
• Pediatrics
• Remote Monitoring

Interventions

Type	Name	Description
DEVICE	Vitls Tego Device	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.

Timeline

• Start date: 2022-02-28
• Primary completion: 2023-05-16
• Completion: 2023-05-16
• First posted: 2022-02-18
• Last updated: 2023-05-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study