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

Heart Rate Clinical Trial

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

Clinical Trial Summary

This proposal describes the evaluation of a CE-marked, FDA cleared vital signs Surveillance Monitoring system within an adult in-patient setting 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. If any heart, respiration rate or skin temperature values move outside of pre-defined high and low limits (individually set for each patient) an alert is raised. ECG arrhythmia detection algorithms automatically record and send ECG data if the patient is suspected to be experiencing an arrhythmia event (Asystole, Ventricular Fibrillation, Tachycardia or Bradycardia). This proposal describes the evaluation of RENEW's Aingeal device within an adult in-patient setting 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03750318
Study type Interventional
Source KK Women's and Children's Hospital
Contact
Status Active, not recruiting
Phase N/A
Start date January 31, 2019
Completion date December 31, 2024
View Details
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