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Clinical Trials/NCT04142073
NCT04142073
Completed
N/A

Advanced Wireless and Wearable Sensors for Patients With Critical Neonatal and Pediatric Congenital Heart Defects

Northwestern University1 site in 1 country30 target enrollmentApril 16, 2019
ConditionsCCU Inpatients

Overview

Phase
N/A
Intervention
Not specified
Conditions
CCU Inpatients
Sponsor
Northwestern University
Enrollment
30
Locations
1
Primary Endpoint
Percent agreement with pilot sensor and current standard of vital signs monitoring
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

This is a pilot study is to test a wireless, skin-sensor device against current technology in the CCU to monitor vitals

Detailed Description

This is a single center, prospective, observational study that will recruit subjects from Lurie Children's Hospital to test a wireless vitals monitor against the current vitals monitors used in the Cardiac Care Unit.

Registry
clinicaltrials.gov
Start Date
April 16, 2019
End Date
June 30, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Stephanie Rangel

Director CTU

Northwestern University

Eligibility Criteria

Inclusion Criteria

  • Patients under the age of eighteen admitted to the Lurie's Children's Cardiac Care Unit will be eligible to participate

Exclusion Criteria

  • Patients at imminent risk of death
  • Patients with a skin abnormality that precludes assessment
  • Patients with hyperbilirubinemia and requiring a need for UV light

Outcomes

Primary Outcomes

Percent agreement with pilot sensor and current standard of vital signs monitoring

Time Frame: 1 year

Study Sites (1)

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