Ignite Creation Date:
2024-05-06 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03622996
Status:
UNKNOWN
Last Update Posted:
2019-02-26
First Post:
2018-07-14
Brief Title:
Noncontact Vital Sign Monitoring Using IR-UWB Radar
Sponsor:
Hanyang University
Organization:
Hanyang University
Study Overview
Official Title:
Noncontact Vital Sign Monitoring Using Impulse Radio Ultra-wideband IR-UWB Radar in Neonates and Children
Status:
UNKNOWN
Status Verified Date:
2019-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 sleepingcalm 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
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 sleepingcalm 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None