Noncontact Vital Sign Monitoring Using IR-UWB Radar

NICU Clinical Trial

Official title:

Noncontact Vital Sign Monitoring Using Impulse Radio Ultra-wideband (IR-UWB) Radar in Neonates and Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03622996
• Other study ID #: NRF-2017M3A9E2064735
• Status: Recruiting
• Start date: November 1, 2018
• Est. completion date: December 2021

Study information

• Verified date: February 2019
• Source: Hanyang University
• Contact: Hyun-Kyung Park, Prof
• Phone: 82-2-10-4749-1454
• Email: neopark[@]hanyang.ac.kr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Background: Contact sensors can cause injuries and infections in newborn infants with fragile skin. The impulse radio ultra-wideband (IR-UWB) radar is recently demonstrated in adults as a contactless method to measure heart rate. The purpose of this study is to assess heart rate (HR) in neonates using IR-UWB radar and evaluate its accuracy, compared to the electrocardiogram (ECG) in the neonatal intensive care unit (NICU).

Methods: HR is recorded in newborn infants using both IR-UWB radar 35 cm away from the chest and ECG simultaneously in the NICU. The HR data during sleeping/calm state are automatically collected by a software algorithm. A total values averaged from a 30-second window every 10 s is used for the analysis. Data acquired on the same patient with standard electrocardiogram has been used for comparison.

Description:

Vital sign is recorded by the radar and bedside ECG simultaneously in supine position within an open-air crib.

The three electrodes of the ECG are attached at the standard positions and connected to the BSM-6501K patient monitor (Nihon Kohden, Tokyo, Japan), and vital signs are recorded and extracted.

The data from the radar is connected to a computer through a USB interface, and signal processing has been automatically performed by a software algorithm described by our previous study. A Fourier transform decomposes a signal with respect to time into a frequency component.

Vital sign is recorded continuously, and digital outputs are extracted from periods when no large noise or fluctuation occurs in both methods. While vital sign acquisition is significantly interfered with moving extensively, being in nursing care, repetitive myoclonus, hiccupping, flopping, or crying, the IR-UWB radar system stops the measurements and deletes the motion-contaminated observations automatically by itself. To investigate the artifact and interference by body movement during measurement, the level of movement is integrated based on the change of distance of the body from the radar. The radar transmits dozens of these signals (frames) to the computer every second, and the frame would not be changed if there was no movement within the range of the radar. However, if there is any movement, the difference of two frames (previous - current) is calculated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2021
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Months

Eligibility

Inclusion Criteria:

• full-term neonates (> 37 weeks of gestational age)

Exclusion Criteria:

• patients with congenital anomalies

Related Conditions & MeSH terms

• NICU

Locations

Country	Name	City	State
Korea, Republic of	Hanyang University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanyang University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection rate (total time of successful detection/total measurement time) between the IR-UWB radar and conventional monitor for HR and RR measurement	to assess the potential of IR-UWB radar for monitoring vital signs in neonates, compared to the gold standard monitoring in the NICU	newborns (= 37 weeks gestational age) who are admitted in NICU within 28 days of birth (breathing without any respiratory/oxygen support)
Primary	Correlation by Pearson coefficient between the IR-UWB radar and conventional monitor for HR and RR measurement	to evaluate accuracy of IR-UWB radar for monitoring vital signs in neonates, compared to the gold standard monitoring in the NICU	newborns (= 37 weeks gestational age) who are admitted in NICU within 28 days of birth (breathing without any respiratory/oxygen support)
Primary	Mean difference by Bland-Altman analysis between the IR-UWB radar and conventional monitor for HR and RR measurement	to evaluate accuracy of IR-UWB radar for monitoring vital signs in neonates, compared to the gold standard monitoring in the NICU	newborns (= 37 weeks gestational age) who are admitted in NICU within 28 days of birth (breathing without any respiratory/oxygen support)
Primary	Signal matching (%), defined bpm difference = 5, between the IR-UWB radar and conventional monitor for HR measurement	to evaluate accuracy of IR-UWB radar for monitoring heart rate in neonates, compared to the gold standard monitoring in the NICU	newborns (= 37 weeks gestational age) who are admitted in NICU within 28 days of birth (breathing without any respiratory/oxygen support)