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Evaluation of VITLS Compared to Traditional Inpatient Monitoring in Cardiac Shunt-Dependent Children

NCT05526768 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2024-06-07

No results posted yet for this study

Summary

We are seeing how well a remote monitoring device that looks like a sticker placed on the chest, under the arm can monitor a child's vital signs including oxygen levels compared to the way that we usually get these measurements. The goal of this study is to see if the new sticker can be used for monitoring patients with cardiac shunt dependent heart conditions from home once they are discharged home. Participating children will be monitored for 6-72 hours with the new sticker in addition to his/her usual hospital monitors so the new sticker device can be compared to our hospital monitors.

Conditions

  • Congenital Heart Disease
  • Desaturation of Blood

Interventions

DEVICE

VITLS Device

VITLS remote vital sign monitoring device will be applied to consented patients so data obtained by the device can be compared to data obtained by traditional inpatient hospital monitoring devices.

Sponsors & Collaborators

  • Southwest National Pediatric Device Innovation Consortium (SWPDC)

    collaborator UNKNOWN

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Pamela C Petersen, MD · Texas Children's Hospital/Baylor College of Medicine

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-26
Primary Completion
2023-05-10
Completion
2023-05-10
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05526768 on ClinicalTrials.gov