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

NCT05526768 | Completed FDA Device

• 1 other identifier: H-46463
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

remote monitoring; pulse oximeter; cardiac shunt dependent; Tego; VITLS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Evaluate the ability of VITLS to detect clinically significant SpO2 vital sign events compared to conventional inpatient methods.

  6-72 hours

• Evaluate the ability of VITLS to detect clinically significant Heart Rate vital sign events compared to conventional inpatient methods.

  6-72 hours

Study Arms (1)

VITLS Device

EXPERIMENTAL

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

Interventions

VITLS Device 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.

VITLS Device

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Southwest National Pediatric Device Innovation Consortium (SWPDC): collaborator

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Pamela C Petersen, MD

  Texas Children's Hospital/Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The providers caring for the 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.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatric Critical Care Medicine

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 2, 2022
• Study Start: October 26, 2022
• Primary Completion: May 10, 2023
• Study Completion: May 10, 2023
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)