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

Evaluation of a Novel Remote Vital Sign Monitor Compared to Traditional Inpatient Monitoring in Cardiac Shunt-Dependent Children

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.

Study Overview

• Status: Completed
• Conditions: Congenital Heart Disease; Desaturation of Blood
• Intervention / Treatment: Device: VITLS Device

Detailed Description

Children with congenital heart disease who are cardiac shunt dependent are at increased risk for physiologic decompensation compared to non-shunt dependent children. This can lead to prolonged hospitalizations to facilitate careful vital sign monitoring to detect signs of deterioration early. While home monitoring programs have shown promise in this population, there is currently a shortage of pediatric specific remote monitoring devices that seamlessly provide vital sign results to caregivers and the healthcare team.

Over the past few years, home monitoring programs utilizing portable pulse oximetry to monitor oxygen saturation at home have reported improved survival in infants with single ventricle (cardiac shunt dependent) heart disease. Monitoring vital signs in cardiac shunt-dependent children presents challenges as most pulse oximeters are designed to monitor saturation levels greater than 85% SpO2 and shunt dependent children have baseline saturations closer to 75-85% SpO2. Additionally, traditional pulse oximetry probes are connected to a stationary monitor by leads of varying lengths. Children can easily remove these leads, thereby requiring frequent repositioning of the pulse oximeter. Additional limitations to current technology include inaccurate measurements due to motion artifact, need for frequent probe changes, parental requirement to log and interpret results, and the machines' lack of recording ability. An ideal monitor would be one that has continuous monitoring and recording features and provides feedback to the health care team in real time.

This study aims to evaluate a potential solution to some of the problems faced in home monitoring of cardiac shunt-dependent children. The proposed study device continuously measures pulse oximetry, heart rate, respiratory rate and temperature via a wireless probe that is placed on the child's chest. The device wirelessly transmits and stores the vital sign data continuously and can be accessed by authorized medical providers and the patient's caregivers at all times. The goal of this pilot study is to measure how the study device performs in comparison to standard-of-care hospital monitoring in the patients of interest.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Cardiac shunt-dependent patients aged 0-1 year old located in the Texas Children's Hospital Cardiac Intensive Care Unit (CVICU)

Exclusion Criteria:

• Presence of any implanted metal or electronic medical devices present in the chest (i.e. pace makers)
• Allergy to medical grade (latexfree) adhesive
• Any congenital or acquired desquamating skin condition (e.g., staphylococcal scalded skin syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis)
• Any other medical condition which, in the opinion of the Investigator, could affect the participant's health during trial participation or could compromise his/her ability to participate in the trial.
• In the opinion of the investigator, the participant and his/her parent(s) or legal guardian(s) is not reliable for participation in the trial.
• Parental language of comfort is not English or Spanish.
• Parents do not consent for study inclusion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: VITLS Device; The remote monitoring device (VITLS) will be placed onto the chest of consented patients in a manner that will not interfere with standard in-patient monitoring devices. Subjects will simultaneously be monitored with conventional inpatient methods per the unit routine. The providers caring for participating patients will be blinded to the data being collected by the remote monitoring system and no patient care decisions will be made based on the remote monitoring system. The remote monitoring device will automatically monitor and store the data for each subject by subject ID number. Once at least 6, but up to 72 hours of data have been recorded, the investigational device will be removed. Researchers will then retrospectively obtain the corresponding data from the current standard of care inpatient monitoring devices.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of pulse oximetry	Evaluate the VITLS device's ability to accurately measure pulse oximetry compared to conventional inpatient wall-connected methods in cardiac shunt-dependent children.	6-72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the ability of VITLS to detect clinically significant SpO2 vital sign events compared to conventional inpatient methods.	Clinically significant SpO2 vital sign events are defined as SpO2 less than 75% or SpO2 greater than 90% sustained for 1 minute.	6-72 hours
Evaluate the ability of VITLS to detect clinically significant Heart Rate vital sign events compared to conventional inpatient methods.	Clinically significant vital sign events are defined as heart rate less than 100 bpm or heart rate greater than 180 bpm sustained for 1 minute.	6-72 hours

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Collaborators: Southwest National Pediatric Device Innovation Consortium (SWPDC)
• Investigators: Principal Investigator: Pamela C Petersen, MD, Texas Children's Hospital/Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2022
• Primary Completion (Actual): May 10, 2023
• Study Completion (Actual): May 10, 2023

Study Registration Dates

• First Submitted: August 30, 2022
• First Submitted That Met QC Criteria: August 31, 2022
• First Posted (Actual): September 2, 2022

Study Record Updates

• Last Update Posted (Actual): June 7, 2024
• Last Update Submitted That Met QC Criteria: June 6, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: remote monitoring; pulse oximeter; cardiac shunt dependent; Tego; VITLS
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: H-46463

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No