NCT03754231

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: KK Women's and Children's Hospital · Other Government
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Vital Sign
• Heart Rate
• Respiratory Rate

Interventions

Type	Name	Description
OTHER	Heart rate monitoring	The heart rate of recruited patients will be monitored for 15 minutes over 2 phases: i) 10 minutes at rest ii) 5 minutes during physical activity in the form of walking or playing
OTHER	Respiratory rate monitoring	The heart rate of recruited patients will be monitored for 15 minutes over 2 phases: i) 10 minutes at rest ii) 5 minutes during physical activity in the form of walking or playing

Timeline

• Start date: 2018-01-30
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2018-11-27
• Last updated: 2022-03-31

Locations

1 site across 1 country: Singapore