Vitls Feasibility Physiologic Monitoring

Pediatrics Clinical Trial

Official title:

Vitls Feasibility Physiologic Monitoring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05245747
• Other study ID #: Study00001853
• Status: Completed
• Start date: February 28, 2022
• Est. completion date: May 16, 2023

Study information

• Verified date: May 2023
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 16, 2023
• Est. primary completion date: May 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pediatrics
• Remote Monitoring
• Vital Signs

Intervention

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.

Locations

Country	Name	City	State
United States	Children's Mercy Kansas City	Kansas City	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City	American College of Cardiology, Vitls Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

Kumar N, Akangire G, Sullivan B, Fairchild K, Sampath V. Continuous vital sign analysis for predicting and preventing neonatal diseases in the twenty-first century: big data to the forefront. Pediatr Res. 2020 Jan;87(2):210-220. doi: 10.1038/s41390-019-0527-0. Epub 2019 Aug 4. — View Citation

Sasangohar F, Davis E, Kash BA, Shah SR. Remote Patient Monitoring and Telemedicine in Neonatal and Pediatric Settings: Scoping Literature Review. J Med Internet Res. 2018 Dec 20;20(12):e295. doi: 10.2196/jmir.9403. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vital sign Heart Rate Feasibility	To evaluate the feasibility of collecting heart rate data with the Vitls Platform	90 days
Primary	Vital sign Oxygen saturation Feasibility	To evaluate the feasibility of collecting oxygen saturation data with the Vitls Platform	90 days
Primary	Vital sign Temperature Feasibility	To evaluate the feasibility of collecting temperature data with the Vitls Platform	90 days
Primary	Vital sign respiratory rate Feasibility	To evaluate the feasibility of collecting respiratory rate data with the Vitls Platform	90 days

External Links

•   Vitls Website