KK Women's and Children's Hospital
Singapore, 229899
NCT Number: NCT03754231
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.
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Notify Me3 year–17 year
All sexes
Interventional
Not applicable
Singapore, 229899
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Time frame: 15 minutes
Heart rate is calculated manually via ECG waveform and compared against the Aingeal device using Bland Altman approach
Time frame: 15 minutes
Repiratory rate measurement is compared between Aingeal device and Capnostream device using Bland Altman approach.
KK Women's and Children's Hospital
Other Gov
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