Noncontact Vital Sign Monitoring Using IR-UWB Radar

NCT ID: NCT03622996

Last Updated: 2019-02-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2021-12-31

Brief 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.

Detailed 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.

Conditions

NICU

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• patients with congenital anomalies

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hanyang University

OTHER

Sponsor Role: lead

Responsible Party

Hyun-Kyung Park

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

JH Ahn

Role: STUDY_DIRECTOR

Hanyang University, Seoul, Korea

Locations

Hanyang University College of Medicine

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Hyun-Kyung Park, Prof

Role: CONTACT

neopark@hanyang.ac.kr

82-2-10-4749-1454

Facility Contacts

Hyun-Kyung Park, Prof

Role: primary

neopark@hanyang.ac.kr

82-2-01-4749-1454

Other Identifiers

NRF-2017M3A9E2064735

Identifier Type: -

Identifier Source: org_study_id