Clinical trial NCT03622996: Noncontact Vital Sign Monitoring Using IR-UWB Radar
Official title: Noncontact Vital Sign Monitoring Using Impulse Radio Ultra-wideband (IR-UWB) Radar in Neonates and Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: NICU
Lead sponsor: Hanyang University
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We prospectively enrolls clinically stable full-term neonates (\> 37 weeks of gestational age) who do not use any respiratory support and have stable vital signs at the NICU

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* patients with congenital anomalies

Primary outcomes:
measure: Detection rate (total time of successful detection/total measurement time) between the IR-UWB radar and conventional monitor for HR and RR measurement
timeFrame: newborns (≥ 37 weeks gestational age) who are admitted in NICU within 28 days of birth (breathing without any respiratory/oxygen support)
measure: Correlation by Pearson coefficient between the IR-UWB radar and conventional monitor for HR and RR measurement
timeFrame: newborns (≥ 37 weeks gestational age) who are admitted in NICU within 28 days of birth (breathing without any respiratory/oxygen support)
measure: Mean difference by Bland-Altman analysis between the IR-UWB radar and conventional monitor for HR and RR measurement
timeFrame: newborns (≥ 37 weeks gestational age) who are admitted in NICU within 28 days of birth (breathing without any respiratory/oxygen support)
measure: Signal matching (%), defined bpm difference ≤ 5, between the IR-UWB radar and conventional monitor for HR measurement
timeFrame: newborns (≥ 37 weeks gestational age) who are admitted in NICU within 28 days of birth (breathing without any respiratory/oxygen support)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University College of Medicine
Study officials:
affiliation: Hanyang University, Seoul, Korea
name: JH Ahn
role: STUDY_DIRECTOR
References: