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OpenTrials
Completed

NCT Number: NCT05245747

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.

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Key information

Age range

Up to 2 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Mercy Kansas City

Kansas City, Missouri, 64108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitls Tego Device

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.

Other names: Tego VSS Sensor

Primary outcomes

  1. Vital sign Heart Rate Feasibility

    Time frame: 90 days

    To evaluate the feasibility of collecting heart rate data with the Vitls Platform

  2. Vital sign Oxygen saturation Feasibility

    Time frame: 90 days

    To evaluate the feasibility of collecting oxygen saturation data with the Vitls Platform

  3. Vital sign Temperature Feasibility

    Time frame: 90 days

    To evaluate the feasibility of collecting temperature data with the Vitls Platform

  4. Vital sign respiratory rate Feasibility

    Time frame: 90 days

    To evaluate the feasibility of collecting respiratory rate data with the Vitls Platform

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Collaborators

  • American College of Cardiology
  • Vitls Inc.

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 18, 2022
Registry last updated
May 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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