Children's Mercy Kansas City
Kansas City, Missouri, 64108, United States
NCT Number: NCT05245747
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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Notify MeUp to 2 year
All sexes
Observational
Kansas City, Missouri, 64108, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 90 days
To evaluate the feasibility of collecting heart rate data with the Vitls Platform
Time frame: 90 days
To evaluate the feasibility of collecting oxygen saturation data with the Vitls Platform
Time frame: 90 days
To evaluate the feasibility of collecting temperature data with the Vitls Platform
Time frame: 90 days
To evaluate the feasibility of collecting respiratory rate data with the Vitls Platform
Children's Mercy Hospital Kansas City
Other
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