CCU Wireless Vital Signs Monitoring

July 24, 2023 updated by: Stephanie Rangel, Northwestern University

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

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

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 18 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Children under 18 years of age

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent agreement with pilot sensor and current standard of vital signs monitoring
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

Ann & Robert H Lurie Children's Hospital of Chicago

Investigators

  • Study Director: Stephanie Rangel, Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2019

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

October 25, 2019

First Submitted That Met QC Criteria

October 25, 2019

First Posted (Actual)

October 29, 2019

Study Record Updates

Last Update Posted (Actual)

July 25, 2023

Last Update Submitted That Met QC Criteria

July 24, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SX08072018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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