Validation Study on RENEW's Aingeal at KK Women's and Children's Hospital

Heart Rate Clinical Trial

Official title: Validation Study on RENEW's Aingeal at KK Women's and Children's Hospital

Status Completed

Clinical Trial Summary

This proposal describes the evaluation of a CE-marked, FDA cleared vital signs Surveillance Monitoring system in a paediatric outpatient population in KK Women's and Children's Hospital ("KKH"), the main tertiary women and children hospital in Singapore. User acceptance of Aingeal and the Surveillance System will be considered within the clinical settings.

Clinical Trial Description

RENEW's Surveillance Monitoring system is made up of two main components:

a patient-worn wireless vital signs monitor (Aingeal) that transmits data over Wi-Fi to a central station software platform (Surveillance Station). The Aingeal device measures single lead ECG, heart rate, respiration waveform and rate, and skin temperature. A snapshot of data is transmitted by the devices intermittently to the Surveillance Station, enabling vital signs trends to be plotted. This proposal describes the evaluation of RENEW's Aingeal device in a paediatric outpatient population in KK Women's and Children's Hospital ("KKH"), the main tertiary women and children hospital in Singapore. In the paediatric population, assessment of RENEW's Aingeal device will include the accuracy of the device at deriving heart rate from single lead ECG and at deriving respiratory rate when compared against a commonly used vital signs monitor. User acceptance of Aingeal and the Surveillance System will be considered within the clinical settings. ;

Related Conditions & MeSH terms

• Heart Rate
• Respiratory Rate
• Vital Sign

• NCT number: NCT03754231
• Study type: Interventional
• Source: KK Women's and Children's Hospital
• Status: Completed
• Phase: N/A
• Start date: January 30, 2018
• Completion date: December 1, 2021