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Vitls Feasibility Physiologic Monitoring

NCT05245747 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2023-05-18

No results posted yet for this study

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.

Conditions

  • Vital Signs
  • Pediatrics
  • Remote Monitoring

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Lori Erickson, PhD · Children's Mercy Hospital Kansas City

Eligibility

Max Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-28
Primary Completion
2023-05-16
Completion
2023-05-16
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05245747 on ClinicalTrials.gov