Comparison of Continuous Non-invasive All Vital Signs Monitoring Devices With Invasive Gold Standard for Children

Hypertension Clinical Trial

— VT  

Official title:

Validation of Vital Signs Recording With VT-Patch® or VT-Watch® Connected Devices in Children Hospitalized in NICU and PICU

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05451875
• Other study ID #: VT001
• Status: Not yet recruiting
• Start date: January 15, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2022
• Source: VitalTracer Ltd.
• Contact: Azadeh Dastmalchi, PhD
• Phone: +1(613)2761413
• Email: azadeh.dastmalchi[@]vitaltracer.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this clinical study, the investigator will compare vital signs measurements obtained using the non-invasive, wireless VitalTracert monitoring devices (both a VT-Watch and a VT-Patch) to a proprietary continuous physiological data collection tool in 40 patients including 16 patients with an invasive arterial line catheter (radial or femoral) at the pediatric intensive care unit.

Description:

Detailed Description:

The VitalTracer non-invasive, wireless monitoring device is based on reflective photoplethysmograph (PPG) technology. It measures several vital signs, including Oxygen saturation, ECG, blood pressure, respiratory rate, heart rate and skin temperature. The data is transmitted to VitalTracer's application (in Google Play) and is available as a full monitoring system in a hospital setting. The aim of this study is to compare the VitalTracer monitor with the invasive method of blood pressure and SPO2 measurements. The study population includes 40 patients admitted to NICU and PICU. Once in the intensive care unit, the investigator will attach the VitalTracer non-invasive monitor (both a VT-watch and a VT-patch), which are identical in terms of the monitoring system, and monitor the participants for 24 hours. Though both methods are continuous, the investigator will record the vital signs every 1 minute during the 24 hours of the study.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 31, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 18 Years

Eligibility

Inclusion Criteria:

• PICU monitoring for the next 24 hours

Exclusion Criteria:

• Recent cardiac or thoracic surgery

• Thoracic skin lesion that contraindicates the VT patch

• No parental consent

• Intermittent presence of one study observer in the patient room considered inappropriate by the physician or the nurse in charge because of the child's medical condition

Related Conditions & MeSH terms

• Blood Pressure
• Children
• Hypertension
• Intensive Care Unit
• Neonatal
• Oxygen Saturation
• Vital Signs

Intervention

Device:
• Non-invasive monitoring
Comparison of VitalTracer monitoring devices with invasive and/or non-invasive gold standard reference

Locations

Country	Name	City	State
Canada	VitalTracer Ltd	Côte Saint-Luc	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
VitalTracer Ltd.	St. Justine's Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of VitalTracer devices Oxygen Saturation (SPO2) measurement	Percentage of the difference between the absolute value of SpO2 recorded by VT-Patch® or VT-Watch® and the one recorded in high resolution database.	24 hours per subject
Secondary	Accuracy of VitalTracer devices blood pressure, heart rate, skin temperature, and Electrocardiogram (ECG) measurement.	Percentage of the difference between the absolute value of Blood Pressure, Heart Rate and skin temperature and the quality of ECG signals recorded by the VT-Patch® or VT-Watch® and the one recorded in high resolution database.	24 hours per subject