An interventional study of Heart rate monitoring and Respiratory rate monitoring in Vital Sign, Heart Rate and Respiratory Rate, sponsored by KK Women's and Children's Hospital. Completed at 1 site in Singapore. Open to participants aged 3 Years to 17 Years. Per ClinicalTrials.gov, last updated 2022-03-31.
Sponsored by KK Women's and Children's Hospital · Not applicable, Interventional, and Supportive care
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.
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.
KK Women's and Children's Hospital is the lead sponsor of 136 studies on the registry; 33 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All recruited patients will wear the Aingeal device as a form of heart rate monitoring and respiratory rate monitoring in a paediatric outpatient clinic setting.
Other: Heart rate monitoring · 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
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
Heart rate comparison
Heart rate is calculated manually via ECG waveform and compared against the Aingeal device using Bland Altman approach
Time frame: 15 minutes
Respiratory rate comparison
Repiratory rate measurement is compared between Aingeal device and Capnostream device using Bland Altman approach.
Time frame: 15 minutes
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Plan to share: No
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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KK Women's and Children's Hospital