NCT05526768

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Congenital Heart Disease
• Desaturation of Blood

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-10-26
• Primary completion: 2023-05-10
• Completion: 2023-05-10
• First posted: 2022-09-02
• Last updated: 2024-06-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study