NICUNCT03622996
Noncontact Vital Sign Monitoring Using IR-UWB Radar
An observational study of NICU, run by Hanyang University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 1 day to 12 months
- Conditions the study is for
- NICU
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2018to Dec 2021
- How long will I take part?
- 10 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 12 months
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- full-term neonates (> 37 weeks of gestational age)
Who cannot join
- patients with congenital anomalies
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Hanyang University College of Medicine
Seoul, 04763
Hyun-Kyung Park, Prof, 82-2-01-4749-1454, neopark@hanyang.ac.kr
About this study
Official title: Noncontact Vital Sign Monitoring Using Impulse Radio Ultra-wideband (IR-UWB) Radar in Neonates and Children
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.
Read the 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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: newborns (≥ 37 weeks gestational age) who are admitted in NICU within 28 days of birth (breathing without any respiratory/oxygen support)
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
Measured: newborns (≥ 37 weeks gestational age) who are admitted in NICU within 28 days of birth (breathing without any respiratory/oxygen support)
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
Measured: newborns (≥ 37 weeks gestational age) who are admitted in NICU within 28 days of birth (breathing without any respiratory/oxygen support)
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
Measured: newborns (≥ 37 weeks gestational age) who are admitted in NICU within 28 days of birth (breathing without any respiratory/oxygen support)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start1 Nov 2018
- Primary completionMar 2019 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NICUStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 10 Days
Sponsor and investigators
- Lead sponsor
- Hanyang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun-Kyung Park, Hanyang University
- Investigators
- JH Ahn, Study director, Hanyang University, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622996
- Sponsor's protocol ID
- NRF-2017M3A9E2064735
- Status last verified
- Feb 2019
- First submitted
- 14 Jul 2018
- Last updated
- 26 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noncontact Vital Sign Monitoring Using Impulse Radio Ultra-wideband (IR-UWB) Radar in Neonates and Children
- ClinicalTrials.gov ID
- NCT03622996
- Acronym / sponsor ID
- NRF-2017M3A9E2064735
- Conditions
- NICU
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hanyang UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 9 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 10 Days
Who may qualify
- Ages
- 1 day to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (1 listed)
- full-term neonates (> 37 weeks of gestational age)
Key exclusion criteria (1 listed)
- patients with congenital anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JH Ahn study director
Hanyang University, Seoul, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NICU, run by Hanyang University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyun-Kyung Park, Prof (82-2-10-4749-1454, neopark@hanyang.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.