Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Noncontact Vital Sign Monitoring Using IR-UWB Radar

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03622996
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Hyun-Kyung Park, Hanyang University

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.


Condition or disease
NICU

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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 10 Days
Official Title: Noncontact Vital Sign Monitoring Using Impulse Radio Ultra-wideband (IR-UWB) Radar in Neonates and Children
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vital Signs




Primary Outcome Measures :
  1. Detection rate (total time of successful detection/total measurement time) between the IR-UWB radar and conventional monitor for HR and RR measurement [ Time Frame: newborns (≥ 37 weeks gestational age) who are admitted in NICU within 28 days of birth (breathing without any respiratory/oxygen support) ]
    to assess the potential of IR-UWB radar for monitoring vital signs in neonates, compared to the gold standard monitoring in the NICU

  2. Correlation by Pearson coefficient between the IR-UWB radar and conventional monitor for HR and RR measurement [ Time Frame: newborns (≥ 37 weeks gestational age) who are admitted in NICU within 28 days of birth (breathing without any respiratory/oxygen support) ]
    to evaluate accuracy of IR-UWB radar for monitoring vital signs in neonates, compared to the gold standard monitoring in the NICU

  3. Mean difference by Bland-Altman analysis between the IR-UWB radar and conventional monitor for HR and RR measurement [ Time Frame: newborns (≥ 37 weeks gestational age) who are admitted in NICU within 28 days of birth (breathing without any respiratory/oxygen support) ]
    to evaluate accuracy of IR-UWB radar for monitoring vital signs in neonates, compared to the gold standard monitoring in the NICU

  4. Signal matching (%), defined bpm difference ≤ 5, between the IR-UWB radar and conventional monitor for HR measurement [ Time Frame: newborns (≥ 37 weeks gestational age) who are admitted in NICU within 28 days of birth (breathing without any respiratory/oxygen support) ]
    to evaluate accuracy of IR-UWB radar for monitoring heart rate in neonates, compared to the gold standard monitoring in the NICU



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • patients with congenital anomalies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03622996


Contacts
Layout table for location contacts
Contact: Hyun-Kyung Park, Prof 82-2-10-4749-1454 neopark@hanyang.ac.kr

Locations
Layout table for location information
Korea, Republic of
Hanyang University College of Medicine Recruiting
Seoul, Korea, Republic of, 04763
Contact: Hyun-Kyung Park, Prof    82-2-01-4749-1454    neopark@hanyang.ac.kr   
Sponsors and Collaborators
Hanyang University
Investigators
Layout table for investigator information
Study Director: JH Ahn Hanyang University, Seoul, Korea

Additional Information:

Layout table for additonal information
Responsible Party: Hyun-Kyung Park, MD, PhD, Hanyang University
ClinicalTrials.gov Identifier: NCT03622996    
Other Study ID Numbers: NRF-2017M3A9E2064735
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No