Clinical trial NCT05245747: Vitls Feasibility Physiologic Monitoring
Official title: Vitls Feasibility Physiologic Monitoring
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vital Signs
Pediatrics
Remote Monitoring
Keywords: pediatric
physiologic vital signs
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
Collaborators: name: Vitls Inc.
name: American College of Cardiology
First posted: 2022-02-18
Enrollment: 20
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Maximum of 50 infants to be enrolled (with the hope to have evaluable data from 20 of these subjects - i.e. this will allow us to account for possible participant attrition, particularly in the beginning of the trial, and the enrollment of up to 25 patients will allow for the learning curve that will have to be overcome by the study team).

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Vital sign Heart Rate Feasibility
timeFrame: 90 days
measure: Vital sign Oxygen saturation Feasibility
timeFrame: 90 days
measure: Vital sign Temperature Feasibility
timeFrame: 90 days
measure: Vital sign respiratory rate Feasibility
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Kansas City
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: Lori Erickson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.