Status:
COMPLETED
Vitls Feasibility Physiologic Monitoring
Lead Sponsor:
Children's Mercy Hospital Kansas City
Collaborating Sponsors:
Vitls Inc.
American College of Cardiology
Conditions:
Vital Signs
Pediatrics
Eligibility:
All Genders
Up to 2 years
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...
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 ...
Eligibility Criteria
Inclusion
- • 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
- • 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.
Key Trial Info
Start Date :
February 28 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 16 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05245747
Start Date
February 28 2022
End Date
May 16 2023
Last Update
May 18 2023
Active Locations (1)
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1
Children's Mercy Kansas City
Kansas City, Missouri, United States, 64108