Pediatrics Clinical Trial
Official title:
Vitls Feasibility Physiologic Monitoring
Verified date | May 2023 |
Source | Children's Mercy Hospital Kansas City |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Children's Mercy Kansas City | Kansas City | Missouri |
Lead Sponsor | Collaborator |
---|---|
Children's Mercy Hospital Kansas City | American College of Cardiology, Vitls Inc. |
United States,
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
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 |
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