Noncontact Vital Sign Monitoring Using IR-UWB Radar

NCT03622996 | Unknown

• 1 other identifier: NRF-2017M3A9E2064735
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

NICU

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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

  newborns (≥ 37 weeks gestational age) who are admitted in NICU within 28 days of birth (breathing without any respiratory/oxygen support)

Eligibility Criteria

• Age: 1 Day - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

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

You may not qualify if:

• patients with congenital anomalies

Sponsors & Collaborators

• Hanyang University: lead

Study Sites (1)

Hanyang University College of Medicine

Seoul, 04763, South Korea

RECRUITING

Study Officials

• JH Ahn

  Hanyang University, Seoul, Korea

  STUDY DIRECTOR

Central Study Contacts

Hyun-Kyung Park, Prof

CONTACT

82-2-10-4749-1454; neopark@hanyang.ac.kr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 14, 2018
• First Posted: August 9, 2018
• Study Start: November 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: December 1, 2021
• Last Updated: February 26, 2019

Record last verified: 2019-02

Locations

KR (1)